RESEARCH, RESULTS AND STUDIES
A critical aim of the BDI is to engage in small-scale and large-scale research projects to help us better understand the emotional and psychological aspects of diabetes and how we might better use this knowledge to support people with diabetes around the world. To provide an overall sense of BDI’s efforts and directions in this area, we have included here a select list of peer-reviewed published studies that were directed by the BDI or that included BDI staff as key contributors.
AUTHORS: Aaisha Farooqi, Clare Gillies, Harini Sathanapally, Sophia Abner, Sam Seidu, Melanie J Davies, William H Polonsky, Kamlesh Khunti
DATE: November 19, 2021
AIMS: Diabetes can significantly impact quality of life and mental health. However, inconsistencies have been reported in the prevalence of depression in those with Type 1 and Type 2 diabetes, and those without. Systematic reviews also included studies without adequate control subjects. We update existing literature, by comparing depression prevalence between individuals with and without Type 1 and Type 2 diabetes.
METHODS: A systematic review and meta-analysis. We searched MEDLINE, EMBASE and PSYCHINFO, from January 1985 to August 2021. Studies were excluded if they failed to have an adequate control group, specified type of diabetes, or reported depression prevalence by type of diabetes.
RESULTS: 44 studies were selected for inclusion. The prevalence of depression was significantly higher in people with Type 1 (22% vs 13%, OR = 2.10 (95% CI: 1.23, 3.52)), or Type 2 diabetes (19% vs 11%, OR = 1.76 (1.55, 2.01)) compared to those without diabetes. There was no association between study effect size and mean age or gender. Findings did not significantly differ between methods of depression assessment. Prevalence of depression in people with diabetes was higher in studies carried out in specialist care (36%, OR = 3.14 (2.12, 4.63)) compared to those in community or primary care (12%, OR = 1.51 (1.35, 1.70) and in low- and middle-income countries (OR = 2.58 (1.91, 3.50) compared to countries with high income economies (OR = 1.59 (1.39, 1.82)).
CONCLUSIONS: Depression prevalence remains significant in those with type 1 and type 2 diabetes. Effective chronic disease management in people with diabetes is important, particularly screening and managing depression and diabetes distress in specialist care settings.
AUTHORS: Marc Evans, Susanne Engberg, Mads Faurby, João Diogo Da Rocha Fernandes, Pollyanna Hudson, William Polonsky
DATE: November 14, 2021
We designed a systematic literature review to identify available evidence on adherence to and persistence with antidiabetic medication in people with type 2 diabetes (T2D). Electronic screening and congress searches identified real-world noninterventional studies (published between 2010 and October 2020) reporting estimates of adherence to and persistence with antidiabetic medication in adults with T2D, and associations with glycaemic control, microvascular and/or macrovascular complications, hospitalizations and healthcare costs. Ninety-two relevant studies were identified, the majority of which were retrospective and reported US data. The proportions of patients considered adherent (median [range] 51.2% [9.4%-84.3%]) or persistent (median [range] 47.7% [16.9%-94.0%]) varied widely across studies. Multiple studies reported an association between greater adherence/persistence and greater reductions in glycated haemoglobin levels. Better adherence/persistence was associated with fewer microvascular and/or macrovascular outcomes, although there was little consistency across studies in terms of which outcomes were improved. More adherent and more persistent patients were typically less likely to be hospitalized or to have emergency department visits/admissions and spent fewer days in hospital annually than less adherent/persistent patients. Greater adherence and persistence were generally associated with lower hospitalization costs, higher pharmacy costs and lower or budget-neutral total healthcare costs compared with lower adherence/persistence. In conclusion, better adherence and persistence in people with T2D is associated with lower rates of microvascular and/or macrovascular outcomes and inpatient hospitalization, and lower or budget-neutral total healthcare expenditure. Education and treatment strategies to address suboptimal adherence and persistence are needed to improve clinical and economic outcomes.
AUTHORS: Stephanie Edwards, Xuanyao He, Wenjie Wang, Jiat-Ling Poon, Eric Meadows, David Price, Jennal Johnson, Howard Wolpert, William Polonsky
DATE: November 1, 2021
OBJECTIVE: This study used connected pen to determine missed bolus dose (MBD) frequency during masked and unmasked continuous glucose monitoring (CGM) periods and examined its link with time-in-range (TIR), time-above-range (TAR), time-below-range (TBR), and key participant characteristics in people with diabetes.
METHODS:This was a 12-week, single-arm, exploratory, two-period study for people with type 1 diabetes (T1D) or type 2 diabetes (T2D). The primary objective was to estimate the average number of MBD during masked and real-time CGM use. The secondary objective was to estimate the average percent TIR and its relationship to MBD. An exploratory objective was to investigate the participant characteristics that were associated with MBD. Data were analyzed for differences in MBD by diabetes type and other participant characteristics, by CGM period, and by hypoglycemic fear scores.
RESULTS:Participants (n = 64; T1D, n = 38; T2D, n = 26) were 48 ± 11.9 years old and 44% were female. From the masked to the unmasked period, MBD, %TAR, %TBR, and glycated hemoglobin decreased significantly (0.74 MBD/day to 0.62 MBD/day, P = 0.008; 53.6%-48.1%, P = 0.004; 4.49%-2.93%, P < 0.001; mean 8.8%-8.4%, P < 0.001, respectively), while %TIR increased significantly (41.9%-49.0%, P < 0.001). MBD/day was negatively associated with TIR (P = 0.016) and positively associated with TAR (P = 0.015) for T1D and positively associated with TBR (P = 0.024) for T2D in the masked period only. MBD was significantly associated with fear of hypoglycemia for T2D, but not T1D.
CONCLUSIONS: MBD is associated with reduced TIR when CGM is masked and tailored therapeutic approaches are needed for T1D and T2D populations.
AUTHORS: Grazia Aleppo, Roy W. Beck, Ryan Bailey, Katrina J. Ruedy, Peter Calhoun, Anne L. Peters, Rodica Pop-Busui, Athena Philis-Tsimikas, Shichun Bao, Guillermo Umpierrez, Georgia Davis, Davida Kruger, Anuj Bhargava, Laura Young, John B. Buse, Janet B. McGill, Thomas Martens, Quang T. Nguyen, Ian Orozco, William Biggs, K. Jean Lucas, William H. Polonsky, David Price, Richard M. Bergenstal, MOBILE Study Group
DATE: September 29, 2021
OBJECTIVE: To explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin.
RESEARCH DESIGN AND METHODS:This multicenter trial had an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months followed by 6 months in which the BGM group continued to use BGM (n = 57) and the CGM group was randomly reassigned either to continue CGM (n = 53) or discontinue CGM with resumption of BGM for glucose monitoring (n = 53).
RESULTS: In the group that discontinued CGM, mean time in range (TIR) 70–180 mg/dL, which improved from 38% before initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months −12% [95% CI −21% to −3%], P = 0.01). In the group that continued CGM use, little change was found in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%, mean change from 8 to 14 months 1% [95% CI −11% to 12%], P = 0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was −6% (95% CI −16% to 4%, P = 0.20).
CONCLUSIONS: In adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about one-half of the initial gain in TIR that had been achieved during CGM use.
AUTHORS: Thomas Martens, Roy W Beck, Ryan Bailey, Katrina J Ruedy, Peter Calhoun, Anne L Peters, Rodica Pop-Busui, Athena Philis-Tsimikas, Shichun Bao, Guillermo Umpierrez, Georgia Davis, Davida Kruger, Anuj Bhargava, Laura Young, Janet B McGill, Grazia Aleppo, Quang T Nguyen, Ian Orozco, William Biggs, K Jean Lucas, William H Polonsky, John B Buse, David Price, Richard M Bergenstal, MOBILE Study Group
DATE: June 8, 2021
IMPORTANCE:Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.
OBJECTIVE: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.
DESIGN, SETTING AND PARTICIPANTS: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.
INTERVENTIONS:Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).
MAIN OUTCOMES AND MEASURES:The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.
RESULTS:Among 175 randomized participants (mean [SD] age, 57  years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.
CONCLUSIONS AND RELEVANCE: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.
AUTHORS: William Polonsky, Cory Gamble, Neeraj Iyer, Mona Martin, Carol Hamersky
DATE: May, 2021
OBJECTIVE: Despite the demonstrated benefits of glucagon-like peptide 1 (GLP-1) receptor agonist therapy, adherence and persistence with this therapy is often challenging. The purpose of this study was to expand current understanding of patients’ experiences, motivations, and challenges relevant to their persistence with GLP-1 receptor agonist therapy.
DESIGN AND METHODS: This noninterventional, cross-sectional, qualitative study used face-to-face interviews with 36 adults with type 2 diabetes who had been treated with at least one GLP-1 receptor agonist medication. Inclusion criteria were: ≥18 years of age, diagnosed with type 2 diabetes, and currently treated with a GLP-1 receptor agonist for ≥1 month at the time of screening (“continuers”) or discontinued use of a GLP-1 receptor agonist ≤1 year of screening but with a total ≥1 month of treatment (“discontinuers”). Interviews were conducted using a semi-structured qualitative interview guide that included open-ended questions and probes to obtain both spontaneous and prompted input from participants about their current and past treatment experiences with GLP-1 receptor agonist therapy.
RESULTS: Among continuers (n = 16), the most commonly identified facilitators supporting the decision to continue were the observations of improved glucose control (50%) and weight loss (55%). Among discontinuers (n = 20), the most commonly identified challenges leading to treatment discontinuation were side effects (55%) and high cost (50%). Continuers were more likely than discontinuers to receive clinically relevant information from their health care team, including facts about GLP-1 receptor agonist medications, likely treatment benefits, the importance of gradual dose titration, and the need to adjust diet after initiation.
CONCLUSIONS:Although cost is a major obstacle to treatment continuation, it can only be resolved through changes in ongoing reimbursement coverage and policies. However, many other obstacles could potentially be addressed (e.g., reducing side effects with gradual dosage titration and setting appropriate expectations regarding efficacy) through more collaborative patient-clinician interactions before initiating therapy.
AUTHORS: W H Polonsky, A L Fortmann, D Price, L Fisher
DATE: March 29, 2021
AIMS: To investigate the problem of adults with type 1 diabetes (T1D) who purposefully keep their glucose levels low, and to explore contributors to, and possible impact of, this potentially dangerous phenomenon.
METHODS: We developed three self-report items as a means to identify individuals who endorse a consistent preference for hypoglycemia over hyperglycemia (“Hyperglycemia Aversives”). In a large T1D survey (n = 219), validated measures of well-being, emotional distress and hypoglycemic awareness, and glycemic metrics derived from the past 14-day period, were used to examine whether Hyperglycemia Aversives could be characterized as a distinct group.
RESULTS: Hyperglycemia Aversives comprised 16.4% of the sample. This unique group demonstrated significantly higher mean %TIR (71.6% vs. 63.6%) and %TBR (5.1% vs. 2.2%), lower mean %TAR > 250 mg/dL (6.0% vs. 10.1%), and higher rates of impaired hypoglycemic awareness and recurrent severe hypoglycemia episodes than the remaining study sample (“Non-Aversives”) (all ps < 0.01). The two groups did not demonstrate significant differences on psychosocial outcomes.
CONCLUSIONS: We identified a group of T1D adults reporting a consistent preference for hypoglycemia over hyperglycemia. These individuals achieve significantly greater %TIR and less %TAR, but at the cost of greater %TBR and more frequent severe hypoglycemia episodes.
AUTHORS: Howard Wolpert, William H Polonsky, David Rodbard
DATE: March 29, 2021
The advent of connected insulin pens will generate an avalanche of digital insulin data, especially in the context of prandial- and multiple daily injection-insulin regimens. There is a need for the diabetes community to develop standards for such data, analogous to what has been achieved using the ambulatory glucose profile and associated metrics for glucose, permitting harmonization of data reporting for multiple devices and facilitating integration of glucose, insulin, food intake, and physical activity data. Several studies have estimated the timing of meals by analyses of glucose excursions but using diverse criteria. There is need for uniform criteria for multiple types of insulin boluses, including premeal, perimeal, delayed, missed, and correction boluses to facilitate research studies and patient care. This article contains a first preliminary proposal for standards regarding reporting of insulin dosing data. Clinical usage of these reports will require sensitive communication between health care providers and patients.
AUTHORS: Frank J Snoek, Lawrence Fisher, William H Polonsky, Heather Stuckey, Danielle Hessler, Tricia Tang, Norbert Hermanns, Xavier Mundet, Maria Silva, Jackie Sturt, Kentaro Okazaki, Irene Hadjiyianni, Urvi Desai, Magaly Perez-Nieves
DATE: March 27, 2021
Despite the demonstrated benefits of using insulin, nearly a third of the patients with type 2 diabetes (T2D) are initially reluctant to initiate insulin therapy when it is first recommended by their healthcare provider (HCP). Several studies have documented the reasons for this phenomenon known as psychological insulin resistance (PIR) and also identified actionable strategies for HCPs to assist people with T2D to overcome their PIR. However, most strategies are based on the experiences of HCPs, rather than of patients. Based on findings from a study exploring real-world patient experience around HCP actions for mitigating PIR, we suggest that HCPs use collaborative strategies throughout the course of T2D treatment to 1) explore reasons for PIR, 2) help patients overcome PIR, and 3) follow-up regarding experience with insulin.
AUTHORS: Chioma Uzoigwe, Michael Radin, Carol M Hamersky, Mitch DeKoven, Cassie Holt, Swapna Karkare, William H Polonsky
DATE: February 7, 2021
PURPOSE: Five quality of life (QoL) domains are particularly important to patients with type 2 diabetes (T2D) using basal insulin-sense of physical well-being, sense of safety regarding hypoglycemia, sense of diabetes as burdensome, feelings of freedom and flexibility, and sleep quality.
METHODS: An online survey assessed these QoL domains in adult patients with T2D in the USA who had switched from a previous basal insulin to insulin degludec (IDeg): modified versions of the World Health Organization (Five) Well-Being Index (WHO-5), Hypoglycemia Attitudes and Behavior Scale (HABS; confidence and anxiety subscales only), and Diabetes Distress Scale (DDS; emotional burden and regimen-related distress subscales only); three items assessing feelings of freedom and flexibility; and one item assessing sleep quality (hours of restful sleep). Patients rated each item for their previous basal insulin and currently while using IDeg. Correlations between sleep quality and the other QoL scales were also assessed.
RESULTS: In total, 152 patients completed the survey and were included in the study sample. Patients reported significantly improved scores while using IDeg on all WHO-5, DDS, HABS, feelings of freedom and flexibility item scores, and total raw/mean subscale scores (P < 0.0001). Patients also reported a significantly greater number of hours of restful sleep [mean (SD) 6.6 (2.0) vs. 5.5 (1.8); P < 0.0001]. Better sleep quality statistically significantly correlated with improved QoL in all other domains assessed.
CONCLUSIONS: Treatment with IDeg after switching from a previous basal insulin was associated with statistically significant improvements in all QoL domains assessed.
STUDY TITLE: The majority of people with type 1 diabetes and multiple daily insulin injections benefit from using continuous glucose monitoring: An analysis based on the GOLD randomized trial (GOLD-5)
AUTHORS: Arndís F Ólafsdóttir, Jan Bolinder, Tim Heise, William Polonsky, Magnus Ekelund, Magnus Wijkman, Aldina Pivodic, Elsa Ahlén, Erik Schwarcz, Thomas Nyström, Jarl Hellman, Irl B Hirsch, Marcus Lind
DATE: February, 2021
AIM: To identify responders to continuous glucose monitoring (CGM) in relation to reductions in HbA1c and percentage of time spent in hypoglycaemia after initiation of CGM for individuals with type 1 diabetes treated with multiple daily insulin injections.
MATERIALS and METHODS: We analysed data from 142 participants in the GOLD randomized clinical trial. We evaluated how many lowered their HbA1c by more than 0.4% (>4.7 mmol/mol) or decreased the time spent in hypoglycaemia over 24 hours by more than 20 or 30 minutes, and which baseline variables were associated with those improvements.
RESULTS: Lower reduction of HbA1c was associated with greater reduction of hypoglycaemia (r = -0.52; P < .0001). During CGM, 47% of participants lowered their HbA1c values by more than 0.4% (>4.7 mmol/mol) than with self-measurement of blood glucose, and 47% decreased the time spent in hypoglycaemia by more than 20 minutes over 24 hours. Overall, 78% either reduced their HbA1c by more than 0.4% (>4.7 mmol/mol) or the time spent in hypoglycaemia by more than 20 minutes over 24 hours, but only 14% improved both. Higher HbA1c, a lower percentage of time at less than 3.0 or 3.9 mmol/L, a lower coefficient of variation (CV) and a higher percentage of time above 13.9 mmol/L (P = .016) were associated with greater HbA1c reduction during CGM. The variables associated with a greater reduction of time in hypoglycaemia were female sex, greater time with glucose levels at less than 3.0 mmol/L, higher CV, and higher hypoglycaemia confidence as evaluated by a hypoglycaemic confidence questionnaire.
CONCLUSIONS: The majority of people with type 1 diabetes managed by multiple daily insulin injections benefit from CGM; some experienced reduced HbA1c while others reduced the time spent in hypoglycaemia. These factors need to be considered by healthcare professionals and decision-makers for reimbursement and diabetes guidelines.
AUTHORS: William H. Polonsky
DATE: January, 2021
EDITOR’S NOTE: This article is adapted from the virtual address Dr. Polonsky delivered as the recipient of the American Diabetes Association’s (ADA’s) Outstanding Educator in Diabetes Award for 2020. He delivered the address in June 2020 during the Association’s 80th Scientific Sessions, held online as a result of the coronavirus disease 2019.
AUTHORS: Timothy Gilbert, Adam Noar, Olivia Blalock, William Polonsky
DATE: January 20, 2021
BACKGROUND: Initiating continuous glucose monitoring (CGM) can affect HbA1c levels and patients’ relationship to their diabetes. We used real-world HbA1c data to quantify short-term changes in glycemia and validated psychosocial questionnaires to assess changes in quality of life (QoL) indicators in people during their first few months of CGM use.
METHODS: Eligibility was assessed during calls to Dexcom sales regarding its G6 CGM System. Eligibility criteria included ages 25-65 years, type 1 (T1D) or type 2 diabetes (T2D) on intensive insulin therapy, and no prior CGM use. Participants use a web-based portal to complete the 17-item Diabetes Distress Scale (DDS) and the 14-item Hypoglycemia Attitudes and Behavior Scale (HABS); provide validated HbA1c measurements; and share their CGM data pre- and 3-5 months post-CGM initiation. Satisfaction and ease of use with the G6 System were also assessed.
RESULTS: Data were available from 248 patients (182 with T1D, 66 with T2D; 57% male, 88% non-Hispanic white). Mean (SD) HbA1c fell significantly from 8.2 (1.9)% at baseline to 7.1 (1.1)% at the end of the study (p<0.001); more than half (54.4%) of those with initial HbA1c values >7% experienced absolute HbA1c reductions of >1%. Significant reductions in diabetes distress (DDS) and hypoglycemic concerns (HABS) were observed (p<0.001). Most (93%) participants were satisfied or very satisfied with the G6 System and 73% found it very easy to use.
CONCLUSIONS: The first three months of CGM use was correlated with improvements in psychosocial outcomes and improved HbA1c levels for people with T1D or T2D who use intensive insulin therapy.
AUTHORS: Marcus Lind, Arndís F Ólafsdóttir, Irl B Hirsch, Jan Bolinder, Sofia Dahlqvist, Aldina Pivodic, Jarl Hellman, Magnus Wijkman, Erik Schwarcz, Henrik Albrektsson, Tim Heise, William Polonsky
DATE: January, 2021
OBJECTIVE: Continuous glucose monitoring (CGM) reduces HbA1c and time spent in hypoglycemia in people with type 1 diabetes (T1D) treated with multiple daily insulin injections (MDI) when evaluated over shorter time periods. It is unclear to what extent CGM improves and helps to maintain glucose control, treatment satisfaction, diabetes distress, hypoglycemic concerns, and overall well-being over longer periods of time.
RESEARCH DESIGN and METHODS: The GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in people with T1D treated with MDI. People completing the trial (n = 141) were invited to participate in the current SILVER extension study in which 107 patients continued CGM treatment over 1 year along with the support of a diabetes nurse every 3 months.
RESULTS: The primary end point of the change in HbA1c over 1.0-1.5 years of CGM use compared with previous self-monitoring of blood glucose during GOLD showed a decrease in HbA1c of 0.35% (95% CI 0.19-0.50, P < 0.001). Time spent in hypoglycemia <3.0 mmol/L (54 mg/dL) and <4.0 mmol/L (72 mg/dL) decreased from 2.1% to 0.6% (P < 0.001) and from 5.4% to 2.9% (P < 0.001), respectively. Overall well-being (World Health Organization 5-item well-being index, P = 0.009), treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire, P < 0.001), and hypoglycemic confidence (P < 0.001) increased, while hypoglycemic fear (Hypoglycemia Fear Survey-Worry, P = 0.016) decreased and diabetes distress tended to decrease (Problem Areas in Diabetes Scale, P = 0.06). From randomization and screening in GOLD, HbA1c was lowered by 0.45% (P < 0.001) and 0.68% (P < 0.001) after 2.3 and 2.5 years, respectively.
CONCLUSIONS: The SILVER study supports beneficial long-term effects from CGM on HbA1c, hypoglycemia, treatment satisfaction, well-being, and hypoglycemic confidence in people with T1D managed with MDI.
AUTHORS: W H Polonsky, A L Fortmann
DATE: December, 2020
AIMS: To investigate the impact of time in range (TIR) on mood in adults with type 1 diabetes (T1D).
METHODS: We followed a cohort of 219 T1D adults, all currently employing a real-time continuous glucose monitoring system (RT-CGM), to investigate how daily changes in CGM metrics were associated with nightly reports of positive and negative mood over a two-week period.
RESULTS: Greater daily %TIR (70-180 mg/dL) and less time in “severe” hyperglycemia (% time above range (TAR) > 300 mg/dL) were both significantly associated with higher ratings on all positive mood elements and lower ratings on most negative mood elements (all ps < 0.05). When entered together as predictors, %TIR but not %TAR >300 emerged as an independent predictor of many of the positive and negative mood variables. Neither daily changes in time spent in hypoglycemia (< 70 mg/dL) nor glycemic variability (represented by the coefficient of variation) were significantly related to reported mood.
CONCLUSIONS: This study provides the first evidence that time in range (%TIR) is associated with, and likely enhances, daily mood. Consistent with previous studies, we also found that more time spent in “severe” hyperglycemia is linked to more negative mood.
AUTHORS: Lawrence Fisher, William Polonsky, Adijat Asuni, Yasmin Jolly, Danielle Hessler
DATE: December, 2020
AIMS: To describe the effects of the COVID-19 pandemic on adults with T1D or T2D in the U.S.
METHODS: Participants, recruited from the Taking Control of Your Diabetes Research Registry, were ≥19 years old and diagnosed with either T1D or T2D for ≥12 months. Participants completed an online survey on a HIPAA-protected platform.
RESULTS: Completed surveys were received from 763 T1Ds and 619 T2Ds. Average T1D age was 53.3 (SD = 15.3); average T2D age was 64.9 (SD = 10.3). Both samples were predominantly female, non-Hispanic white and well-educated. Average self-reported HbA1c was 6.9 (SD = 1.0; 52 mmol/mol) for T1Ds and 7.1 (SD = 1.1; 54 mmol/mol) for T2Ds. About 40% of respondents reported that all of their diabetes healthcare appointments at the time were cancelled or postponed, 40% reported a switch to telehealth appointments and almost half reported lower overall satisfaction with these visits (compared to pre-pandemic). There were widespread increases in general and diabetes-related stress and social isolation, and negative effects on disease management. About 25% reported increases in highs, lows, and glucose variability in both groups.
CONCLUSIONS: There has been a substantive increase in level of diabetes-related and general life stress and social isolation due to the pandemic, with a significant impact on disease management.
AUTHORS: William H Polonsky, Jennifer E Layne, Christopher G Parkin, Coco M Kusiak, Nathan A Barleen, David P Miller, Howard Zisser, Ronald F Dixon
DATE: October, 2020
The Onduo Virtual Diabetes Clinic is a telehealth program for people with type 2 diabetes that combines mobile app technology, remote personalized lifestyle coaching, connected blood glucose meters, real-time continuous glucose monitoring (rtCGM) devices, and clinical support from board-certified endocrinologists. This analysis evaluated change in diabetes distress among 228 program participants who reported moderate distress (score 2.0-2.9) or high distress (score ≥3.0) on the 17-item Diabetes Distress Scale (DDS17) at enrollment. Participants reported significant reductions in overall distress from 3.0 ± 0.8 at baseline to 2.5 ± 0.9 (P <0.001) at an average of 6 months of follow-up. Significant reductions in all DDS17 subscale scores were observed; most notable were reductions in the regimen-related and emotional distress subscales (-0.9 and -0.4, respectively; both P <0.001). Significantly greater reductions in overall distress (P = 0.012) and regimen-related distress (P <0.001) were reported by participants who were prescribed and used intermittent rtCGM (n = 77) versus nonusers (n = 151). Although the generalizability of these findings may be limited by the study’s small sample size and potential for self-selection bias, these results do suggest that telemedicine programs such as the Onduo VDC could be a valuable tool for addressing the problem of diabetes-related distress.
AUTHORS: William H Polonsky, Addie L Fortmann
DATE: September 29, 2020
BACKGROUND: To examine experiences with real-time continuous glucose monitoring (RT-CGM) data sharing and its impact on health-related outcomes.
METHODS: Adults with type 1 diabetes (T1D) (N = 302) using the Dexcom G5 Mobile or G6 RT-CGM system and sharing data with ≥1 family/friend follower completed a survey exploring their perceived value of data sharing, the impact of sharing on health and quality of life (QoL) outcomes, and how their chief follower (CF) used shared data to support their diabetes management. Regression analyses examined whether CF actions were linked to reported changes in health and QoL outcomes for the T1D adult.
RESULTS: The majority had lived with T1D >10 years, (76.5%), used RT-CGM >1 year (58.0%), and identified their spouse/partner as CF (51.9%). Data sharing reportedly contributed to improved hypoglycemic confidence (for 89.4% of respondents), improved overall well-being (54.3%), and reduced diabetes distress (36.1%). Benefits related to data sharing included fewer episodes of severe hypoglycemia (62.2%), better sleep (52.4%), and A1C improvement (47.3%). In particular, three positive CF actions were independent predictors of health and QoL benefits: celebrating success related to glycemic control, providing encouragement when glycemic control is challenging, and teamwork discussions about how CF should respond to out-of-range values.
CONCLUSIONS: RT-CGM data sharing was associated with a range of health and QoL-related benefits. The occurrence of benefits was influenced by the collaborative management approaches taken by RT-CGM users and their data-sharing followers. Longitudinal trials are needed to determine the most effective patterns of collaborative data sharing, leading to their implementation into routine diabetes management.
STUDY TITLE: The Association Between HbA 1c and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4)
AUTHORS: Shilan Seyed Ahmadi, Klara Westman, Aldina Pivodic, Arndís F Ólafsdóttir, Sofia Dahlqvist, Irl B Hirsch, Jarl Hellman, Magnus Ekelund, Tim Heise, William Polonsky, Magnus Wijkman, Erik Schwarcz, Marcus Lind
DATE: September, 2020
OBJECTIVE: According to recent guidelines, individuals with type 1 diabetes should spend <4.0% of time per day with glucose levels <3.9 mmol/L (<70 mg/dL) and <1.0% per day with glucose levels <3.0 mmol/L (<54 mg/dL).
RESEARCH DESIGN AND METHODS: In the GOLD randomized crossover trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomized to continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated over 16 months. We estimated the association between time spent in hypoglycemia and various mean glucose and HbA1c levels.
RESULTS: Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA1c and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA1c <7.5% (<58 mmol/mol) had <1.0% time spent in hypoglycemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycemia <3.9 mmol/L. During CGM, mean time spent in hypoglycemia for individuals with mean HbA1c 7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for <3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%, respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
CONCLUSIONS: Reaching current targets for time in hypoglycemia while at the same time reaching HbA1c targets is challenging for patients with type 1 diabetes treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycemia than SMBG at a broad range of HbA1c levels and is crucial for patients with MDI treatment if they are to have a chance to approach hypoglycemia targets.
AUTHORS: Thomas Danne, Vijay N Joish, Marion Afonso, Phillip Banks, Sangeeta Sawhney, Pablo Lapuerta, Michael J Davies, John B Buse, Dee Lin, Matthew Reaney, Sophie Guillonneau, Frank J Snoek, Timothy S Bailey, William Polonsky
DATE: July 28, 2020
BACKGROUND: Diabetes-related distress is common among persons affected by diabetes and is associated with suboptimal glycemic control and complications, thus constituting a relevant patient-report outcome (PRO). Improving glycemic control may reduce diabetes distress and improve treatment satisfaction. This post hoc analysis evaluated PRO data for a pooled cohort of adults with type 1 diabetes (T1D) receiving sotagliflozin as adjunct to optimized insulin in the inTandem1 and inTandem2 studies.
METHODS: Clinically meaningful changes in the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and the two-item Diabetes Distress Scale (DDS2) total and individual scores were examined in the pooled data from the first 24 weeks of the studies.
RESULTS: In the cohort of patients with a baseline DTSQs total score ≤32 (~76% of entire cohort), nearly twice as many patients treated with sotagliflozin 200 (45.9%) or 400 mg (42.3%) experienced a >3-point improvement from baseline vs. those treated with placebo (24%). Treatment with sotagliflozin led to statistically significant (P<0.05) improvements across all DTSQs items. Approximately 42% of all patients were considered to have a high risk of diabetes distress (total DDS2 score ≥6) at baseline, following insulin optimization. More patients shifted from high to low risk with sotagliflozin compared to placebo (~40% vs. 23%; P≤0.0002). The baseline-adjusted difference in DDS2 from placebo was significantly (P<0.001) reduced by -0.5 and -0.6 for sotagliflozin 200 and 400 mg, respectively.
CONCLUSIONS: Patients with T1D treated with sotagliflozin in addition to optimized insulin therapy reported meaningful improvements in treatment satisfaction and diabetes distress.
AUTHORS: W H Polonsky, L Fisher, D Hessler, J Liu, L Fan, A H McAuliffe-Fogarty
DATE: July, 2020
AIMS: To examine the factor structure, validity and reliability of the Hypoglycemic Attitudes and Behavior Scale (HABS) in T1D adults (previously examined only in T2D adults), and to determine if it has unique value, after controlling for hypoglycemic fear.
METHODS: The original 14 HABS items were submitted to a confirmatory factor analysis (CFA) with T1D participants. Construct validity criteria included diabetes distress, generalized anxiety, well-being, hypoglycemic fear, hypoglycemia history and self-reported glycemic control.
RESULTS: A CFA yielded a similar 3-factor solution, with all items loading on the same factors as in the analyses with T2D adults: Hypoglycemia Anxiety, Avoidance and Confidence. Higher levels of Anxiety and Avoidance were significantly associated with poorer well-being and higher levels of generalized anxiety, diabetes distress and hypoglycemic fear, with correlations in the reverse direction for Confidence. After controls (including hypoglycemic fear), the HABS subscales were significantly linked to several criterion variables.
CONCLUSIONS: Though originally developed and validated with T2D adults, the HABS demonstrates sufficient validity and reliability for use with a T1D population; and it captures unique critical elements of hypoglycemic concerns. Thus, it may contribute to a greater understanding of hypoglycemia management and more targeted clinical interventions in a T1D population.
AUTHORS: Tricia Tang, Danielle Hessler, William H Polonsky, Lawrence Fisher, Beverly Reed, Tanya Irani, Urvi Desai, Magaly Perez-Nieves
DATE: March-April, 2020
PURPOSE: To identify specific actions and characteristics of health care providers (HCPs) in the United States and Canada that influenced patients with type 2 diabetes who were initially reluctant to begin insulin.
METHODS: Patients from the United States (n = 120) and Canada (n = 74) were recruited via registry, announcements, and physician referrals to complete a 30-minute online survey based on interviews with patients and providers regarding specific HCP actions that contributed to the decision to begin insulin.
RESULTS: The most helpful HCP actions were patient-centered approaches to improve patients’ understanding of the injection process (ie, “My HCP walked me through the whole process of exactly how to take insulin” [helped moderately or a lot, United States: 79%; Canada: 83%]) and alleviate concerns (“My HCP encouraged me to contact his/her office immediately if I ran into any problems or had questions after starting insulin” [United States: 76%; Canada: 82%]). Actions that were the least helpful included referrals to other sources (ie, “HCP referred patient to a class to help learn more about insulin” [United States: 40%; Canada: 58%]).
CONCLUSIONS: The study provides valuable insight that HCPs can use to help patients overcome psychological insulin resistance, which is a critical step in the design of effective intervention protocols.
AUTHORS: Esteban Jódar, Marie Michelsen, William Polonsky, Rosangela Réa, Anna Sandberg, Tina Vilsbøll, Mark Warren, Signe Harring, Uwe Ziegler, Stephen Bain
DATE: March 30, 2020
AIM: To assess what drives change in health-related quality of life (HRQoL) in type 2 diabetes in the SUSTAIN 6 trial and identify potential mediators of the treatment effect of semaglutide on HRQoL scores.
MATERIALS AND METHODS: The Short Form (SF)-36v2® questionnaire [comprising physical component summary (PCS) and mental component summary (MCS)] was used to assess changes in HRQoL from baseline to week 104, by treatment, in a prespecified analysis. This post-hoc analysis assessed change in PCS and MCS using the following factors as parameter/covariate, using descriptive statistics and linear regressions: major adverse cardiac events, hypoglycaemia, gastrointestinal adverse events, at least one episode of nausea, vomiting or diarrhoea, and change in glycated haemoglobin (HbA1c), body weight, blood pressure, heart rate and estimated glomerular filtration rate.
RESULTS: Mean change in overall PCS score was +1.0 with semaglutide versus +0.4 with placebo, and +0.5 versus -0.2 for MCS. The treatment effect of semaglutide versus placebo (unadjusted estimate) was 0.7 [(95% confidence interval 0.1, 1.2); P = 0.018] on PCS and this was reduced when adjusted for change in HbA1c [0.4 (-0.2, 1.0), P = .167] and body weight [0.3 (-0.3, 0.9), P = .314]. The unadjusted treatment effect on MCS [0.7 (-0.0, 1.5), P = .054] was only reduced when adjusted for change in HbA1c [0.3 (-0.4, 1.1), P = .397]. When adjusting for all other parameters separately, the estimated effect of semaglutide on PCS and MCS qualitatively did not change.
CONCLUSIONS: Semaglutide improved HRQoL versus placebo; greater improvements with semaglutide versus placebo were possibly mediated, in part, by change in HbA1c and body weight. Clinicaltrials.gov: NCT01720446 (SUSTAIN 6).
AUTHORS: Winkley K, Upsher R, Polonsky WH, Holmes-Truscott E.
DATE: March, 2020
AIM: The aim of this narrative review was to determine the contribution of behavioural and psychosocial research to the field of medication-taking for adults with type 2 diabetes over the past 25 years. We review the behavioural and psychosocial literature relevant to adults with type 2 diabetes who are treated with oral antidiabetes agents, glucagon-like peptide-1 receptor agonists and insulin. Delayed uptake of, omission of and non-persistence with medications are significant problems among adults with type 2 diabetes. At each stage of the course of diabetes, during which medication to lower blood glucose is initiated or intensified, ~50% of people take less medication than prescribed. Research aimed at increasing optimal medication-taking behaviour has targeted ‘forgetfulness’, developing interventions which aid medication-taking, such as reminder devices, with limited success. In parallel, investigation of beliefs about medication has provided insights into the perceived necessity of and concerns about medication and how these inform medication-taking decisions. Guidance is available for health professionals to facilitate shared decision-making, particularly with insulin therapy; however, interventions addressing medication beliefs are limited. Optimal medication-taking behaviour is essential to prevent hyperglycaemia in adults with type 2 diabetes. Evidence from the past 25 years has demonstrated the association between medication beliefs and medication-taking behaviour. Health professionals need to address medication concerns, and establish and demonstrate the utility of diabetes medication with the individual within the clinical consultation. There are interventions that may assist diabetes health professionals in the shared decision-making process, but further development and more robust evaluation of these tools and techniques is required.
AUTHOR: William H Polonsky
DATE: March, 2020
The success of diabetes technologies depends on the attitudes and behavior of the individuals who choose to adopt them. Real-time continuous glucose monitoring, continuous subcutaneous insulin infusion, and sensor-augmented pump systems may positively affect diabetes-related quality of life (QOL), although the influence on QOL outcomes seems to be modest and the results from randomized controlled trials are limited and controversial. In contrast, more consistently positive QOL-related responses are apparent from observational data. The newer generations of devices hold the promise for more strongly enhancing diabetes-related QOL. Appropriate training and ongoing support are likely to be the key to successful uptake.
AUTHOR: Guzman, SJ.
DATE: February, 2020
From a behavioral perspective, therapeutic inertia can happen when obstacles to changing a diabetes treatment plan outweigh perceived benefits. There is a complex interaction of important treatment-related obstacles for people with diabetes (PWD), their treating health care professional (HCP), and the clinical setting in which they interact. Tipping the scales toward more effective action involve strategies that increase perceptions of the benefits of treatment intensification while addressing important obstacles so that treatment changes are seen by both PWD and HCPs as worthwhile and achievable.
AUTHORS: Lawrence Fisher, William Polonsky, Vicky Bowyer, Danielle Hessler
DATE: January 11, 2020
AIMS: To assess between-group differences in participant experiences in a two-arm diabetes distress (DD) reduction RCT and to determine their relationship to clinical outcomes (reductions in DD and HbA1C).
METHODS: For high DD adults with Type 1 diabetes and HbA1c ≥7.5% participating in T1-REDEEM, we evaluated post intervention 5-point ratings of overall program “helpfulness” and program component “helpfulness,” along with open-ended feedback statements using 10 qualitative codes. We compared responses of those in OnTrack, a distressed-focused intervention, with KnowIt, an education/management intervention.
RESULTS: Those in OnTrack reported significantly higher levels of overall program helpfulness and greater helpfulness of each component of the program, greater group support, far fewer negative experiences, and more active and meaningful group engagement than those who participated in KnowIt. Ratings of helpfulness were unrelated to reductions in DD and HbA1C in both study arms. As previously reported, these findings occurred despite significant reductions in both DD and HbA1C in both arms with no between-group differences.
CONCLUSIONS: Findings highlight the importance of addressing the personal experience of diabetes interventions in clinical care as separate, distinct outcomes. Personal experience may not always be related to changes in traditional clinical indicators.
AUTHORS: Heather Stuckey, Lawrence Fisher, William H Polonsky, Danielle Hessler, Frank J Snoek, Tricia S Tang, Norbert Hermanns, Xavier Mundet-Tuduri, Maria Elizabeth Rossi da Silva, Jackie Sturt, Kentaro Okazaki, Dachuang Cao, Irene Hadjiyianni, Jasmina I Ivanova, Urvi Desai, Magaly Perez-Nieves
DATE: December 11, 2019
OBJECTIVE: To understand participant perceptions about insulin and identify key behaviors of healthcare professionals (HCPs) that motivated initially reluctant adults from seven countries (n=40) who had type 2 diabetes (T2D) to start insulin treatment.
RESEARCH DESIGN AND METHODS: Telephone interviews were conducted with a subset of participants from an international investigation of adults with T2D who were reluctant to start insulin (EMOTION). Questions related to: (a) participants’ thoughts about insulin before and after initiation; (b) reasons behind responses on the survey that were either ‘not helpful at all’ or ‘helped a lot’; (c) actions their HCP may have taken to help start insulin treatment; and (d) advice they would give to others in a similar situation of starting insulin. Responses were coded by two independent reviewers (kappa 0.992).
RESULTS: Starting insulin treatment was perceived as a negative experience that would be painful and would lead down a ‘slippery slope’ to complications. HCPs engaged in four primary behaviors that helped with insulin acceptance: (1) showed the insulin pen/needle and demonstrated the injection process; (2) explained how insulin could help with diabetes control and reduce risk of complications; (3) used collaborative communication style; and (4) offered support and willingness to answer questions so that participants would not be ‘on their own’. Following initiation, most participants noted that insulin was not ‘as bad as they thought’ and recommended insulin to other adults with T2D.
CONCLUSIONS: Based on these themes, two actionable strategies are suggested for HCPs to help people with psychological insulin resistance: (1) demonstrate the injection process and discuss negative perceptions of insulin as well as potential benefits; (2) offer autonomy in a person-centred collaborative approach, but provide support and accessibility to address concerns. These findings help HCPs to better understand ways in which they can engage reluctant people with T2D with specific strategies.
AUTHORS: Polonsky WH, Fortmann AL, Johnson KE, Nguyen A, Beebe C.
DATE: November 8, 2019
BACKGROUND: Hypoglycemic confidence (HC) represents the degree to which an individual feels secure regarding his or her ability to stay safe from hypoglycemia-related problems. Self-report scales assessing HC in adults with type 1 diabetes (T1D) have found that greater HC is associated with better glycemic control and that HC rises significantly after real-time continuous glucose monitoring is introduced. To determine whether HC might be similarly meaningful in the partners of T1D adults, we developed the Hypoglycemic Confidence Scale for Partners (Partner-HCS). This article describes the construction and validation of the Partner-HCS and examines how HC in T1D partners is related to hypoglycemia-related experience and key psychosocial constructs.
METHODS: Items were developed from interviews with seven T1D partners, resulting in 12 self-report items. Exploratory factor analysis (EFA) was then conducted on data collected from T1D partners (n = 218). Variables to establish construct validity for the Partner-HCS included partner-reported diabetes distress, hypoglycemic fear, generalized anxiety, and confidence regarding glucagon use, as well as frequency of recent severe hypoglycemia in the T1D adult. Hierarchical regression analyses examined the unique contribution of Partner-HCS scores, independent of hypoglycemic fear, to key psychosocial constructs and hypoglycemia-related factors.
RESULTS: EFA of the 12 items yielded a single-factor solution, accounting for 51.2% of the variance. Construct validity was demonstrated by significant univariate associations with key psychosocial constructs. Importantly, Partner-HCS total score was, independent of hypoglycemic fear, significantly associated with diabetes distress (P < 0.05), overall relationship satisfaction (P = 0.004), number of severe hypoglycemic episodes in the last 6 months (P < 0.05), and confidence using glucagon (P = 0.007). In total, 38.5% of T1D partners indicated relatively low HC.
CONCLUSIONS: HC is an important facet of the experiences of T1D partners. It is related to, yet distinct from, hypoglycemic fear. The Partner-HCS is a reliable, valid method for assessing HC in partners of T1D adults.
AUTHORS: Leahy JJL, Aleppo G, Fonseca VA, Garg SK, Hirsch IB, McCall AL, McGill JB, Polonsky WH.
DATE: October 7, 2019
Faster-acting insulins, new noninsulin drug classes, more flexible insulin-delivery systems, and improved continuous glucose monitoring devices offer unprecedented opportunities to improve postprandial glucose (PPG) management and overall care for adults with insulin-treated diabetes. These developments led the Endocrine Society to convene a working panel of diabetes experts in December 2018 to assess the current state of PPG management, identify innovative ways to improve self-management and quality of life, and align best practices to current and emerging treatment and monitoring options. Drawing on current research and collective clinical experience, we considered the following issues for the ∼200 million adults worldwide with type 1 and insulin-requiring type 2 diabetes: (i) the role of PPG management in reducing the risk of diabetes complications; (ii) barriers preventing effective PPG management; (iii) strategies to reduce PPG excursions and improve patient quality of life; and (iv) education and clinical tools to support endocrinologists in improving PPG management. We concluded that managing PPG to minimize or prevent diabetes-related complications will require elucidating fundamental questions about optimal ways to quantify and clinically assess the metabolic dysregulation and consequences of the abnormal postprandial state in diabetes and recommend research strategies to address these questions. We also identified practical strategies and tools that are already available to reduce barriers to effective PPG management, optimize use of new and emerging clinical tools, and improve patient self-management and quality of life.
AUTHORS: Shumway M, Fisher L, Hessler D, Bowyer V, Polonsky WH, Masharani U.
DATE: August 15, 2019
AIM: This study evaluated the implementation costs of two group interventions, one focused on diabetes education (KnowIt) and one focused directly on diabetes distress (OnTrack), that reduced diabetes distress and HbA1C in adults with poorly controlled type 1 diabetes (T1DM) in the T1-REDEEM trial.
METHODS: Resources used to provide interventions were enumerated using activity-based micro-costing methods. Costs were assigned to resources in 2017 US dollars. US median wage and benefit rates were used to calculate costs of staff time. Cost per unit change was calculated for diabetes distress and HbA1C.
RESULTS: For both interventions, per participant implementation costs were approximately $250 and cost per 1.0 percentage point (11 mmol/mol) change in HbA1C was $1400. Cost per unit change in diabetes distress was $364 for KnowIt and $335 for OnTrack. No statistically significant differences in costs were observed.
CONCLUSIONS: This is the first study to examine the costs of implementing interventions targeting diabetes distress in the context of T1DM. Both interventions had per participant implementation costs in the lower end of the range of previously examined diabetes self-management interventions ($219 to $5390). These inventions and their costs merit further attention because reducing diabetes distress may impact long term T1DM outcomes.
CLINICAL TRIALS REGISTRATION: ClinicalTrials.govNCT02175732.
AUTHORS: Hessler D, Fisher L, Polonsky W, Strycker L, Parra J, Bowyer V, Dedhia M, Masharani U.
DATE: August 5, 2019
AIM: To compare the effect of targeted interventions to reduce high diabetes distress among adults with Type 1 diabetes with a comparison sample of similar but untreated individuals, and to document the stability of untreated diabetes distress over time.
METHODS: A total of 51 adults with Type 1 diabetes with elevated baseline diabetes distress (distress score ≥ 2.0) and HbA1c levels (≥ 58 mmol/mol) were identified from a longitudinal, non-intervention study, and compared with a similar sample of 51 participants in an intervention study. Both groups completed the T1-DDS diabetes distress questionnaire at baseline and 9 months.
RESULTS: Large and significant reductions in diabetes distress scores were recorded in the intervention group (mean ± sd change = -0.6 ± 0.6), while minimal change was found in the non-intervention group (-0.2 ± 0.6, group effect P = 0.002; effect size d = 0.67). Additional analyses using the established minimal clinically important difference for the T1-DDS showed that diabetes distress increased significantly (minimal clinically important difference ≥ 1) or persisted at high levels for 51% of participants in the non-intervention group, compared with 23.5% in the intervention group.
CONCLUSIONS: Our results showed that targeted interventions led to dramatic reductions in diabetes distress compared with a lack of treatment. We also conclude that elevated diabetes distress, when left unaddressed, does not resolve over time and often remains chronic. (Clinical Trials Registry no.: NCT02175732).
AUTHORS: Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Håkan-Bloch J, Tadayon S, Davies MJ.
DATE: June 19, 2019
AIM: To investigate treatment satisfaction with semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, versus placebo/active comparators in the SUSTAIN clinical trial programme.
METHODS: In SUSTAIN 2-5 and 7, the Diabetes Treatment Satisfaction Questionnaire was used to evaluate patient-perceived treatment satisfaction, hyperglycaemia and hypoglycaemia. Post hoc subgroup analyses were conducted to explore the effects of gastrointestinal adverse events (GI AEs), weight loss (≥5%) or achieving glycaemic (HbA1c < 7%) targets on treatment satisfaction.
RESULTS: Overall treatment satisfaction increased from baseline to end of treatment with all treatments across trials. Improvements were significantly greater with semaglutide versus comparators/placebo in SUSTAIN 2-5 (all P < 0.05), and generally greater in patients who achieved versus did not achieve weight loss and glycaemic targets, often with greater improvements with semaglutide 1.0 mg versus comparator/placebo in both weight loss groups. In SUSTAIN 7, improvements in overall treatment satisfaction were generally similar between semaglutide and dulaglutide, irrespective of weight loss or glycaemic control. In SUSTAIN 7, changes in overall treatment satisfaction score were generally lower in patients with versus without GI AEs at week 16 (except dulaglutide 0.75 mg), but similar by week 40. Perceived hyperglycaemia was significantly reduced from baseline to end of treatment with semaglutide versus all comparators/placebo (all P < 0.05). No differences between treatments were observed for perceived hypoglycaemia.
CONCLUSIONS: Semaglutide was associated with significantly greater (SUSTAIN 2-5) or similar (SUSTAIN 7) improvements in overall treatment satisfaction versus comparators/placebo. Improvements in overall treatment satisfaction were generally greater in patients achieving versus not achieving treatment targets. Clinicaltrials.gov: NCT01930188 (SUSTAIN 2), NCT01885208 (SUSTAIN 3), NCT02128932 (SUSTAIN 4), NCT02305381 (SUSTAIN 5) and NCT02648204 (SUSTAIN 7). EudraCT: 2012-004827-19 (SUSTAIN 2), 2012-004826-92 (SUSTAIN 3), 2013-004392-12 (SUSTAIN 4), 2013-004502-26 (SUSTAIN 5) and 2014-005375-91 (SUSTAIN 7).
AUTHORS: Barnard-Kelly KD, Polonsky WH.
DATE: May 21, 2019
BACKGROUND: Increasing numbers of people with diabetes, especially those with type 1 diabetes (T1D), are using continuous glucose monitoring (CGM) systems to support their diabetes self-management, yet even so only approximately 30% of individuals with T1D meet the American Diabetes Association HbA1c target of 58 mmol/mol (7.5%) for children and 53 mmol/mol (7.0%) for adults. We aimed to produce a useful tool for people with diabetes to improve personalized understanding of CGM.
METHOD: A brief leaflet titled “Guidelines to Improve Glucose Control Using CGM” was developed for people with diabetes. Semistructured interviews were held with 12 adults with T1D, focusing on their views regarding the relevance, readability, and usability of the newly revised leaflet. Participants were specifically asked to share what they would find most useful in terms of information and advice provided as well as how to make use of that in the context of their own diabetes self-management. Data were analyzed thematically and used to inform revisions of the leaflet content.
RESULTS: Data highlighted information and advice needs as well as personalization in terms of own diabetes management.
CONCLUSIONS: CGM systems are associated with improved medical and psychosocial outcomes, especially when used effectively to meet the individual needs of the user. Ensuring greater understanding of the individual’s expectations when first starting CGM, matching experience and skills to meet those expectations, and tailoring use to the individual needs of each person with diabetes (PWD) are all required to achieve widespread and consistent benefit.
AUTHORS: Fisher L, Polonsky WH, Hessler D
DATE: April 15, 2019
Addressing the emotional side of diabetes and its management has received considerable attention in recent years. At the centre of most of these efforts is the concept of ‘diabetes distress’, a generic term that captures the primary sources and intensity of emotional distress associated with diabetes and its management over time. As interest in diabetes distress has grown, however, it has been difficult to integrate and translate the various strands of clinical research in a manner that can guide diabetes distress intervention efforts in the real world of clinical care. The aim of this paper is to fill this gap by outlining practical strategies for intervention in clinical settings and to assist diabetes healthcare professionals in thinking through how diabetes distress might be addressed practically in their clinics. To address these goals, this review is divided into five sections: a definition of diabetes distress, ways diabetes distress can be assessed and monitored, information about diabetes distress for use in intervention planning, topics to be considered for inclusion in diabetes distress interventions, and alternatives for where in the care process a diabetes distress intervention might be considered. We focus on diabetes distress experienced by adults with both Type 1 and Type 2 diabetes.
AUTHORS: Polonsky WH, Fisher L, Hessler D, Stuckey H, Snoek FJ, Tang T, Hermanns N, Mundet X, Silva M, Sturt J, Okazaki K, Hadjiyianni I, Cao D, Ivanova J, Desai U, Perez-Nieves M
DATE: April, 2019
AIMS: To identify actions of healthcare professionals (HCPs) that facilitate the transition to insulin therapy (IT) in type 2 diabetes (T2D) adults.
METHODS: Included were T2Ds in seven countries (n = 594) who reported initial IT reluctance but eventually began IT. An online survey included 38 possible HCP actions: T2Ds indicated which may have occurred and their helpfulness. Also reported were delays in IT start after initial recommendation and any period of IT discontinuation.
RESULTS: Exploratory factor analysis of HCP actions yielded five factors: “Explained Insulin Benefits” (EIB), “Dispelled Insulin Myths” (DIM), “Demonstrated the Injection Process” (DIP), “Collaborative Style” (CS) and “Authoritarian Style” (AS). Highest levels of helpfulness occurred for DIP, EIB and CS; lowest for AS. Participants who rated DIP as helpful were less likely to delay IT than those who rated DIP as less helpful (OR = 0.75, p = 0.01); participants who rated CS and EIB as helpful were less likely to interrupt IT than those who rated these as less helpful (OR = 0.55, p < 0.01; OR = 0.51, p = 0.01, respectively).
CONCLUSIONS: Three key HCP actions to facilitate IT initiation were identified as helpful and were associated with more successful initiation and persistence. These findings may aid the development of interventions to address reluctance to initiating IT.
AUTHORS: Down S, Alzaid A, Polonsky WH, Belton A, Edelman S, Gamerman V, Nagel F, Lee J, Emmerson J, Capehorn M.
DATE: February, 2019
AIMS: Physician-patient communication when discussing the need for additional oral medication for type 2 diabetes (add-on) may affect the self-care of people with this condition. We aimed to investigate physicians’ recalled experiences of the add-on consultation.
METHODS: We conducted a cross-sectional survey of physicians treating people with type 2 diabetes in 26 countries, as part of a large cross-national study of physician-patient communication during early treatment of type 2 diabetes (IntroDia®). The survey battery included novel questions about physician experiences at add-on and the Jefferson Scale of Physician Empathy.
RESULTS: Of 9247 eligible physicians, 6753 responded (73.0% response rate). Most (82%) agreed that physician-patient discussions at add-on strongly influence patients’ disease acceptance and treatment adherence. Half the physicians reported ≥1 challenge in most or all add-on conversations, with a significant inverse relationship between frequency of challenges and Jefferson Scale of Physician Empathy score (standardised β coefficient: -0.313; p < 0.001). Physicians estimated that only around half their patients with type 2 diabetes follow their self-care advice. Exploratory factor analysis of physician beliefs about why their patients did not follow recommendations yielded two distinct dimensions: psychosocial barriers (e.g. depressed mood) and personal failings of the patient (e.g. not enough willpower) (r = 0.37, p < 0.001).
CONCLUSIONS: Physicians’ empathy and beliefs about their patients may play a significant role in their success with the add-on conversation and, consequently, promotion of patient engagement and self-care. Although the study was limited by its retrospective, cross-sectional nature, the findings from IntroDia® may inform efforts to improve diabetes care.
AUTHORS: Edelman S, Belton A, Down S, Alzaid A, Capehorn M, Gamerman V, Nagel F, Lee J, Emmerson J, Polonsky WH.
DATE: January 24, 2019
AIMS: To investigate experiences of people with type 2 diabetes (T2DM) at the clinic visit when an additional oral antidiabetes drug (OAD) is prescribed, and how this affects their quality of life, self-management and key outcomes.
METHODS: We surveyed adults with T2DM from a large multinational study of patient-physician communication during early T2DM treatment (IntroDia®). We examined their experiences when an additional OAD is prescribed (“add-on”) after initial OAD monotherapy, focusing on 24 key conversational elements, overall patient-perceived communication quality (PPCQ), and associations with current patient-reported outcomes. The links between PPCQ and people’s efforts to delay add-on therapy were also assessed.
RESULTS: 4235 people with T2DM prescribed an additional OAD, or a combination of two, were analysed. Exploratory factor analyses of the conversational elements during add-on yielded three coherent, meaningful factors: Encouraging (Cronbach’s α = 0.62), Collaborative (α = 0.81), and Discouraging (α = 0.81). PPCQ was positively associated with Encouraging (β = +1.252, p < 0.001) and Collaborative (β = +1.206, p < 0.001), but negatively associated with Discouraging (β = -0.895, p < 0.001). Better PPCQ at add-on was associated with less diabetes distress, greater well-being and better self-care at the present time. Approximately 20% of people bargained (two-thirds successfully) with their physician to delay additional medication. Non-bargaining individuals reported significantly better mean PPCQ, diabetes distress, well-being and self-care than those who bargained.
CONCLUSIONS: Encouraging and patient-inclusive conversations at add-on moments may improve patient well-being and self-care outcomes. People with T2DM who attempted to delay additional medication reported poorer PPCQ and outcomes.
AUTHORS: Ray KK, Kendall DM, Zhao Z, Peng X, Caballero AE, Polonsky WH, Nordstrom BL, Fan L, Curtis BH, Davies MJ.
DATE: December, 2018
AIMS: To describe global patterns of insulin treatment and to assess the impact of patient, provider, health system and economic influences on treatment decisions for patients with insulin-treated type 2 diabetes (T2D).
METHODS: This prospective cohort study of insulin-treated patients with T2D was conducted across 18 countries categorized as high, upper-middle or lower-middle income regions. Information collected from patients included knowledge of diabetes, experiences and interactions with their healthcare provider. Physician information included specialty, practice size, availability of diabetes support services, volume of diabetes patients treated and time spent per patient. Physicians determined an individualized haemoglobin A1c (HbA1c) target for each patient by the start of the study. Changes in T2D therapies and HbA1c were recorded for 2 years.
RESULTS: Complete treatment data were available for 2528 patients. Median age was 61 years and median duration of diabetes was 11.4 years. Changes to treatment regimen occurred in 90.0% of patients, but changes were less common in countries with a higher economic status (P < 0.001). Most treatment changes involved insulin, with changes in dose the most common. Overall predictors of change in insulin therapy included younger age, use of any insulin regimen other than basal only, higher mean baseline HbA1c and longer duration of T2D. HbA1c levels remained constant regardless of regional economic status. At baseline, 20.6% of patients were at their HbA1c target; at 2 years this was 26.8%.
CONCLUSIONS: Among insulin-treated patients with T2D, treatment changes were common; however, only approximately one-fourth of individuals achieved their HbA1c target.
AUTHORS: Goldman JD, Gill J, Horn T, Reid T, Strong J, Polonsky WH.
DATE: October, 2018
INTRODUCTION: Persistence with basal insulin therapy can be suboptimal, despite recent improvements in insulin formulations and delivery systems. Patient support programs may help increase adherence. This study evaluated the impact of the Toujeo® COACH support program, which provides patients with continuing and individualized education and advice on lifestyle changes, by assessing its effect on number of refills and days on therapy.
METHODS: The study population included 1724 patients with diabetes who filled a first prescription for insulin glargine 300 U/mL (Gla-300) between April and December 2015 and received a welcome call from a Guide, and 1724 matched control patients from the Symphony Health Integrated Dataverse® prescription claims database. Control patients received Gla-300 but did not enroll in the program. These patients were matched based on age, gender, location, prior use of insulin, insulin dose, number of concomitant drugs, and copay tier.
RESULTS: The COACH and control groups comprised 52% men and 48% women; 22% were aged 18-47 years, 23% were 48-55 years, 27% 56-61 years, and 28% ≥ 62 years. Most (99%) had used insulin in the year before receiving the welcome call. At 6 months, patients in the COACH group had refilled their prescription 3.2 times on average, compared with 2.4 times for control patients (P < 0.0001); at 9 months, the average number of refills was 4.7 and 3.6, respectively (P < 0.0001). The average number of days on therapy at 6 months was 102.2 days in the COACH group and 81.5 days in the control group (P < 0.0001); at 9 months, the average number of days on therapy was 151.9 and 121.6, respectively (P < 0.0001).
CONCLUSIONS: Patients in the COACH program were significantly more likely to refill their prescriptions and stay on therapy. Patient support programs such as the COACH program could be an effective way to help improve diabetes care.
AUTHORS: Fisher L, Hessler D, Polonsky WH, Masharani U, Guzman S, Bowyer V, Strycker L, Ahmann A, Basina M, Blumer I, Chloe C, Kim S, Peters AL, Shumway M, Weihs K, Wu P
DATE: September, 2018
OBJECTIVE: To compare the effectiveness of two interventions to reduce diabetes distress (DD) and improve glycemic control among adults with type 1 diabetes (T1D).
RESEARCH DESIGN AND METHODS: Individuals with T1D (n = 301) with elevated DD and HbA1c were recruited from multiple settings and randomly assigned to OnTrack, an emotion-focused intervention, or to KnowIt, an educational/behavioral intervention. Each group attended a full-day workshop plus four online meetings over 3 months. Assessments occurred at baseline and 3 and 9 months. Primary and secondary outcomes were change in DD and change in HbA1c, respectively.
RESULTS: With 12% attrition, both groups demonstrated dramatic reductions in DD (effect size d = 1.06; 78.4% demonstrated a reduction of at least one minimal clinically important difference). There were, however, no significant differences in DD reduction between OnTrack and KnowIt. Moderator analyses indicated that OnTrack provided greater DD reduction to those with initially poorer cognitive or emotion regulation skills, higher baseline DD, or greater initial diabetes knowledge than those in KnowIt. Significant but modest reductions in HbA1c occurred with no between-group differences. Change in DD was modestly associated with change in HbA1c (r = 0.14, P = 0.01), with no significant between-group differences.
CONCLUSIONS: DD can be successfully reduced among distressed individuals with T1D with elevated HbA1c using both education/behavioral and emotion-focused approaches. Reductions in DD are only modestly associated with reductions in HbA1c. These findings point to the importance of tailoring interventions to address affective, knowledge, and cognitive skills when intervening to reduce DD and improve glycemic control.
AUTHORS: Hessler DM, Fisher L, Polonsky WH, Bowyer V, Potter M
DATE: July, 2018
OBJECTIVE: To identify and assess patient motivation to initiate or maintain behavior changes.
METHODS: Attitudinal statements were developed from structured patient interviews and translated into 18 survey items. Items were analyzed with exploratory factor analysis (EFA).
RESULTS: An EFA with 340 type 2 diabetes patients identified three areas of patient attitudes toward changing health behaviors: (1) willingness to make changes (3 items; α = 0.69), (2) perceived ability to make or maintain changes (3 items; α = 0.74), and (3) and feeling changes are worthwhile (3 items; α = 0.61). Greater perceived ability and feelings of worthwhileness were associated with positive psychosocial and behavioral management indicators. All three areas were associated with confidence and attitudes toward making a specific behavioral change (e.g., improve diet).
CONCLUSIONS: MATCH is an internally consistent and valid 9-item scale that provides a profile of factors influencing motivation that can be used in clinical and research settings.
AUTHORS: Weatherall J, Polonsky WH, Lanar S, Knoble N, Håkan-Bloch J, Constam E, Philis-Tsimikas A, Marrel A
DATE: May 3, 2018
BACKGROUND: Anecdotal reports suggest that insulin degludec (IDeg) may offer unique health-related quality of life (HRQoL) benefits. As the nature of these benefits remain unclear, this study utilized qualitative research methods to investigate and elucidate the experience of “feeling better” after initiating IDeg.
METHODS: Twenty adults with type 2 diabetes (T2D) who reported “feeling better” on IDeg for > 3 months participated in 90-min interviews. One focus group and nine telephone interviews were conducted at two sites in the United States (US) and one focus group was conducted in Switzerland. Patients were ≥ 18 years of age, did not take mealtime insulin, and had switched to IDeg from another basal insulin. Discussions were audio-recorded, transcribed and translated (Swiss German). Utilizing grounded theory, transcripts were analyzed by sorting quotes into concepts using thematic analysis.
RESULTS: Participants’ mean age was 66 years and the average duration of T2D was 17.6 years. Mean duration of IDeg use was 1.45 years. Four major factors were identified as key contributors to patients’ sense of “feeling better”: 1) reduced sense of diabetes as burdensome and requiring excessive attention; 2) enhanced feelings of adaptability and freedom; 3) heightened sense of security, especially regarding concerns about hypoglycemia; and 4) greater sense of physical well-being (greater energy/less fatigue). Content saturation was achieved. Generally, patients from the US sites were more focused on medical results than Swiss patients, who were more likely to identify IDeg’s effect on overall HRQoL. A limitation of the study was that the population was primarily white, > 60 and otherwise healthy (no comorbid physical or mental condition).
CONCLUSIONS: A group of patients with T2D, who had switched to IDeg from another basal insulin, reported HRQoL benefits which were attributed to both diabetes-specific improvements (feeling less burdened by day-to-day diabetes demands) and non-specific gains (greater energy). The conclusions may have limited transferability due to the characteristics of the sample population and further research is needed.
STUDY TITLE: A Randomized Clinical Trial of the Effect of Continuous Glucose Monitoring on Nocturnal Hypoglycemia, Daytime Hypoglycemia, Glycemic Variability, and Hypoglycemia Confidence in Persons with Type 1 Diabetes Treated with Multiple Daily Insulin Injections (GOLD-3)
AUTHORS: Ólafsdóttir AF, Polonsky W, Bolinder J, Hirsch IB, Dahlqvist S, Wedel H, Nyström T, Wijkman M, Schwarcz E, Hellman J, Heise T, Lind M.
DATE: April, 2018
BACKGROUND: To evaluate the effects of continuous glucose monitoring (CGM) on nocturnal and daytime hypoglycemia in persons with type 1 diabetes treated with multiple daily insulin injections (MDI); we also evaluated factors related to differences in hypoglycemia confidence in this population.
METHODS: Evaluations were performed from the GOLD randomized trial, an open-label multicenter crossover randomized clinical trial (n = 161) over 69 weeks comparing CGM to self-measurement of blood glucose (SMBG) in persons with type 1 diabetes treated with MDI. Masked CGM and the hypoglycemia confidence questionnaire were used for evaluations.
RESULTS: Time with nocturnal hypoglycemia, glucose levels <70 mg/dL was reduced by 48% (10.2 vs. 19.6 min each night, P < 0.001) and glucose levels <54 mg/dL by 65%. (3.1 vs. 8.9 min, P < 0.001). For the corresponding glucose cutoffs, daytime hypoglycemia was reduced by 40% (29 vs. 49 min, P < 0.001) and 54% (8 vs. 18 min., P < 0.001), respectively. Compared with SMBG, CGM use improved hypoglycemia-related confidence in social situations (P = 0.016) and confidence in more broadly avoiding serious problems due to hypoglycemia (P = 0.0020). Persons also reported greater confidence in detecting and responding to decreasing blood glucose levels (thereby avoiding hypoglycemia) during CGM use (P = 0.0033) and indicated greater conviction that they could more freely live their lives despite the risk of hypoglycemia (P = 0.022).
CONCLUSIONS: CGM reduced time in both nocturnal and daytime hypoglycemia in persons with type 1 diabetes treated with MDI and improved hypoglycemia-related confidence, especially in social situations, thus contributing to greater well-being and quality of life.
AUTHORS: Polonsky WH, Fisher L, Hessler D.
DATE: April, 2018
AIMS: To determine the impact of frequency of non-severe hypoglycemic events (NSHE) and the perceived burden of NSHE on quality of life (QOL) over time.
METHODS: T2D adults (n = 424) were re-contacted two years after initial QOL assessment. Responding subjects (n = 290) reported the frequency and burden of NSHE over time and completed six generic and diabetes-specific QOL measures.
RESULTS: Most subjects (86%) reported ≥ one NSHE over time. Higher frequency of NSHE was significantly associated with decrements in QOL. Greater perceived burden of NSHE was significantly linked to decreases in QOL over time for all six QOL measures. Interaction terms indicated that participants with a higher frequency of NSHE and higher perceived burden reported the greatest decrease in QOL; participants who experienced frequent NSHE but did not perceive these events as burdensome evidenced little worsening in QOL over time.
CONCLUSIONS: NSHE have a negative impact on QOL over time in T2D adults. However, it is not just the occurrence of NSHE that affects QOL; it is the individual’s felt burden of these events that is critical. The greatest reductions in QOL are seen among those subjects reporting a higher frequency of NSHE and indicating that such events are burdensome.
STUDY TITLE: The Use of Language in Diabetes Care and Education
AUTHORS: Dickinson JK, Guzman SJ, Maryniuk MD, O’Brian CA, Kadohiro JK, Jackson RA, D’Hondt N, Montgomery B, Close KL, Funnell MM.
DATE: December, 2017
Language is powerful and can have a strong impact on perceptions as well as behavior. A task force, consisting of representatives from the American Association of Diabetes Educators (AADE) and the American Diabetes Association (ADA), convened to discuss language in diabetes care and education. This document represents the expert opinion of the task force. The literature supports the need for a language movement in diabetes care and education. There are effective ways of communicating about diabetes. This article provides recommendations for language used by health care professionals and others when discussing diabetes through spoken or written words-whether directed to people with diabetes, colleagues, or the general public, as well as research questions related to language and diabetes.
AUTHORS: Fisher L, Polonsky WH, Hessler D, Potter MB.
DATE: December, 2017
A wide range of diabetes-directed interventions – including novel medications, devices and comprehensive education programmes – have been shown to be effective in clinical trials. But in the real world of diabetes care their efficacy is often dependent upon on how well a clinician is able to support personal engagement and motivation of the person with diabetes to use these new tools and knowledge consistently, and as directed. Although many person-centred motivational and behavioural strategies have been developed, for example, action planning, motivational interviewing and empowerment-based communication, the sheer number and apparent lack of clear differences among them have led to considerable confusion. The primary goal of this review, therefore, is to provide a practical framework that organizes and structures these programmes to enhance their more systematic use in clinical care. Its purpose is to enhance clinician efforts to respectfully encourage and support engagement and motivation for behaviour change in people with diabetes. The three-step framework for organizing and describing the specific clinical processes involved is based on self-determination theory and includes: clinician preparation for a different type of clinical encounter, clinician/person with diabetes relationship building, and clinician utilization of specific behavioural tools. We conclude with practical considerations for application of this framework to the real world of clinical care.
AUTHORS: Weissberg-Benchell J, Hessler D, Fisher L, Russell SJ, Polonsky WH,.
DATE: November 6, 2017
OBJECTIVES: The study assessed the psychosocial impact of the bihormonal bionic pancreas (BP) on adults in a real-world outpatient setting.
RESEARCH DESIGN AND METHODS:Thirty-nine adults with type 1 diabetes at four study centers across the U.S. participated in a two-arm, random-order, crossover design study: 11 days with the BP and 11 days with their usual care (UC). Psychosocial questionnaires were administered before the first study arm, at the end of the first study arm, and at the end of the second study arm.
RESULTS: The mean age of participants was 33 years; mean diabetes duration was 17 years; and 84% were non-Hispanic Caucasian. Significantly greater improvements in psychosocial outcomes were found following the use of BP versus UC; these included reductions in diabetes-related distress (P < 0.001) with the greatest drops in distress related to hypoglycemia and to eating constraints, and greater treatment satisfaction (P < 0.05). The majority of BP users described their experience as positive with a reduction in worrying about low (72%) and high (69%) blood sugars. The majority reported trusting the device (69%) and feeling less burdened by the BP than their usual method of diabetes care (64%). Concerns about the burden of the BP were also expressed, with >75% of users highlighting the burden of carrying around the equipment and the need to change glucagon daily, and more than half of the participants reporting concerns about wearability, discomfort, the time it took to correct out-of-range numbers, and “glitches” in the system.
CONCLUSIONS: Overall, participants report substantial psychosocial benefits accruing from the BP relative to their usual method of diabetes care. However, participants also reported a number of burdens associated with the system. Future versions of the BP device should be designed with the goal of addressing these concerns, and studies with larger, more diverse samples, and with more technology-naive participants are needed.
AUTHORS: Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R; DIAMOND Study Group.
DATE: August 22, 2017
BACKGROUND: Continuous glucose monitoring (CGM), which studies have shown is beneficial for adults with type 1 diabetes, has not been well-evaluated in those with type 2 diabetes receiving insulin.
OBJECTIVE: To determine the effectiveness of CGM in adults with type 2 diabetes receiving multiple daily injections of insulin.
DESIGN: Randomized clinical trial. (The protocol also included a type 1 diabetes cohort in a parallel trial and subsequent second trial.) (ClinicalTrials.gov: NCT02282397).
SETTING: 25 endocrinology practices in North America.
PATIENTS: 158 adults who had had type 2 diabetes for a median of 17 years (interquartile range, 11 to 23 years). Participants were aged 35 to 79 years (mean, 60 years [SD, 10]), were receiving multiple daily injections of insulin, and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9% (mean, 8.5%).
INTERVENTION: Random assignment to CGM (n = 79) or usual care (control group, n = 79).
MEASUREMENTS: The primary outcome was HbA1c reduction at 24 weeks.
RESULTS: Mean HbA1c levels decreased to 7.7% in the CGM group and 8.0% in the control group at 24 weeks (adjusted difference in mean change, -0.3% [95% CI, -0.5% to 0.0%]; P = 0.022). The groups did not differ meaningfully in CGM-measured hypoglycemia or quality-of-life outcomes. The CGM group averaged 6.7 days (SD, 0.9) of CGM use per week.
LIMITATION: 6-month follow-up.
CONCLUSION: A high percentage of adults who received multiple daily insulin injections for type 2 diabetes used CGM on a daily or near-daily basis for 24 weeks and had improved glycemic control. Because few insulin-treated patients with type 2 diabetes currently use CGM, these results support an additional management method that may benefit these patients.
PRIMARY FUNDING SOURCE: Dexcom.
AUTHORS: Capehorn M, Polonsky WH, Edelman S, Belton A, Down S, Gamerman V, Nagel F, Lee J, Alzaid A.
DATE: August, 2017
AIMS: To investigate physicians’ recalled experiences of their conversations with patients at diagnosis of Type 2 diabetes, because physician-patient communication at that time may influence the patient’s subsequent self-care and outcomes.
METHODS: As part of a large cross-national study of physician-patient communication during early treatment of Type 2 diabetes (IntroDia® ), we conducted a cross-sectional survey of physicians treating people with Type 2 diabetes in 26 countries across Africa, Asia, Europe, Latin America, the Middle East, North America and Oceania. The survey battery was designed to evaluate physician experiences during diagnosis conversations as well as physician empathy (measured using the Jefferson Scale of Physician Empathy).
RESULTS: A total of 6753 of 9247 eligible physicians completed the IntroDia® survey (response rate 73.0%). Most respondents (87.5%) agreed that the conversation at diagnosis of Type 2 diabetes impacts the patient’s acceptance of the condition and self-care. However, almost all physicians (98.9%) reported challenges during this conversation. Exploratory factor analysis revealed two related yet distinct types of challenges (r = 0.64, P < 0.0001) associated with either patients (eight challenges, α = 0.87) or the situation itself at diagnosis (four challenges, α = 0.72). There was a significant inverse association between physician empathy and overall challenge burden, as well as between empathy and each of the two types of challenges (all P < 0.0001). Study limitations include reliance on accurate physician recall and inability to assign causality to observed associations.
CONCLUSIONS: Globally, most physicians indicated that conversations with patients at diagnosis of Type 2 diabetes strongly influence patient self-care. Higher physician empathy was associated with fewer challenges during the diagnosis conversation.
AUTHORS: Carls GS, Tuttle E, Tan RD, Huynh J, Yee J, Edelman SV, Polonsky WH.
DATE: August 11, 2017
OBJECTIVE: This objective of this study was to estimate and explain the gap between clinical efficacy and real-world (RW) effectiveness of type 2 diabetes medications.
RESEARCH DESIGN AND METHODS: This mixed-methods quasi-experimental study used retrospective claims (Optum/Humedica) to compare the change in HbA1c of RW patients with type 2 diabetes 12 months after starting a glucagon-like peptide-1 receptor agonist (GLP-1RA) or dipeptidyl peptidase-4 inhibitor (DPP4) with published findings from randomized controlled trials (RCTs) evaluating these drugs. Selected RW patients were similar to RCT patients, and regression analysis was used in the RW data to adjust for differences between poorly adherent and adherent patients to explain why RCT and RW findings may differ.
RESULTS: RW patients initiating a GLP-1RA (n = 221) or a DPP4 (n = 652) experienced smaller reductions in HbA1c (GLP-1RA: -0.52% [-6 mmol/mol], DPP4: -0.51% [-6 mmol/mol])than reported in RCTs (-1.30% [-14 mmol/mol] from seven GLP-1RA RCTs, n = 2,600; -0.68% [-8 mmol/mol] from four DPP4 RCTs, n = 1,889). Baseline HbA1c, additional medications, and adherence were significant explanatory factors in the RW HbA1c change. Modeled estimates of RCT efficacy (-1.04% GLP-1RA [-12 mmol/mol], -0.69% DPP4 [-8 mmol/mol]) were within the RCTs’ reported range (GLP-1RA: -0.84% to -1.60% [-9 to -18 mmol/mol]; DPP4: -0.47% to -0.90% [-5 to -10 mmol/mol]). Poor medication adherence accounted for approximately three-fourths of the gap between RW and expected RCT results (gap = 0.51% [6 mmol/mol] GLP1-RA; 0.18% [3 mmol/mol] DPP4).
CONCLUSIONS: Poor medication adherence is primarily why RW effectiveness is significantly less than RCT efficacy, suggesting an urgent need to effectively address adherence among patients with type 2 diabetes.
AUTHORS: Edelman SV, Polonsky WH.
DATE: August 11, 2017
Despite U.S. Food and Drug Administration (FDA) approval of over 40 new treatment options for type 2 diabetes since 2005, the latest data from the National Health and Nutrition Examination Survey show that the proportion of patients achieving glycated hemoglobin (HbA1c) <7.0% (<53 mmol/mol) remains around 50%, with a negligible decline between the periods 2003-2006 and 2011-2014. The Healthcare Effectiveness Data and Information Set reports even more alarming rates, with only about 40% and 30% of patients achieving HbA1c <7.0% (<53 mmol/mol) in the commercially insured (HMO) and Medicaid populations, respectively, again with virtually no change over the past decade. A recent retrospective cohort study using a large U.S. claims database explored why clinical outcomes are not keeping pace with the availability of new treatment options. The study found that HbA1c reductions fell far short of those reported in randomized clinical trials (RCTs), with poor medication adherence emerging as the key driver behind the disconnect. In this Perspective, we examine the implications of these findings in conjunction with other data to highlight the discrepancy between RCT findings and the real world, all pointing toward the underrealized promise of FDA-approved therapies and the critical importance of medication adherence. While poor medication adherence is not a new issue, it has yet to be effectively addressed in clinical practice-often, we suspect, because it goes unrecognized. To support the busy health care professional, innovative approaches are sorely needed.
AUTHORS: Polonsky WH, Arsenault J, Fisher L, Kushner P, Miller EM, Pearson TL, Tracz M, Harris S, Hermanns N, Scholz BM, Pollom RK, Perez-Nieves M, Pollom RD, Hadjiyianni I
DATE: August 7, 2017
STUDY TITLE: Real-world weight change among patients treated with glucagon-like peptide-1 receptor agonist, dipeptidyl peptidase-4 inhibitor and sulfonylureas for type 2 diabetes and the influence of medication adherence
AUTHORS: Carls GS, Tan R, Zhu JY, Tuttle E, Yee J, Edelman SV, Polonsky WH.
DATE: July 20, 2017
AIMS: The study aims to examine real-world weight change and the role of medication adherence among patients with type 2 diabetes who initiated one of three drug classes: glucagon-like peptide-1 receptor agonist (GLP-1RA), dipeptidyl peptidase-4 inhibitor (DPP4) and sulfonylureas (SUs).
MATERIALS AND METHODS: A cohort of patients initiating one of the three drug classes was selected from a large US database of integrated electronic medical record and administrative claims. Adherence was defined as per cent of days covered ≥80% during the year following drug initiation. Weight change was calculated from drug initiation (-180, +30 d) to 1 year (±90 d) later. Multivariate regression controlled for baseline differences between adherent and poorly adherent patients and the addition of another drug class during follow-up.
RESULTS: The study included 833 GLP-1RA, 2,272 DPP4 and 2,713 SU patients who contributed 2,279, 6,602 and 7,429 observations respectively. Patients initiating a GLP-1RA achieved the largest weight change (-2.46 kg of GLP-1RA, -1.26 kg of DPP4 and 0.18 kg of SU, P < 0.01). Adherent GLP-1 patients lost 1.73 kg more than poorly adherent patients, and adherent SU patients gained 1.11 kg more than poorly adherent patients (all P < 0.01). Adherent and poorly adherent DPP4 patients experienced approximately the same amount of weight loss.
CONCLUSIONS: Medication adherence can mediate observed weight loss in patients treated with a GLP1-RA or weight gain in those treated with an SU. Medication adherence was low in a real-world population, particularly for GLP-1RA, which displayed the strongest weight loss benefit. Because recent American Diabetes Association guidelines recommend selecting drug therapies that have a weight loss or weight neutral effect for the management of type 2 diabetes patients, patients should be encouraged to enhance their adherence to benefit the most from therapies that have weight loss properties.
STUDY TITLE: Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND): a multicentre, randomised controlled trial
AUTHORS: Beck RW, Riddlesworth TD, Ruedy KJ, Kollman C, Ahmann AJ, Bergenstal RM, Bhargava A, Bode BW, Haller S, Kruger DF, McGill JB, Polonsky W, Price D, Toschi E; DIAMOND Study Group.
DATE: July 12, 2017
BACKGROUND: The benefit of initiation of insulin pump therapy (continuous subcutaneous insulin infusion; CSII) in patients with type 1 diabetes using continuous glucose monitoring (CGM) has not been studied. We aimed to assess glycaemic outcomes when switching from multiple daily injections (MDI) to CSII in adults with type 1 diabetes using CGM.
In this multicentre, randomised controlled trial, 75 adults with type 1 diabetes in the CGM group of the DIAMOND trial were randomly assigned via the study website using a computer-generated sequence to continue MDI or switch to CSII, with continuation of CGM, for 28 weeks. The primary outcome was CGM-measured time in the glucose concentration range of 70-180 mg/dL (3·9-10·0 mmol/L). This study is registered with ClinicalTrials.gov, number NCT02282397.
FINDINGS: Between April 14, 2015, and May 5, 2016, 37 participants were randomly assigned to the CGM plus CSII group and 38 participants were randomly assigned to the CGM plus MDI group. The study was completed by 36 (97%) of 37 participants in the CGM plus CSII group and 35 (92%) of 38 participants in the CGM plus MDI group. Mean CGM use was 6·7 days per week (SD 0·8) in the CGM plus CSII group and 6·9 days per week (0·3) in the CGM plus MDI group (p=0·86). No participants in the CGM plus CSII group who completed the trial discontinued CSII. Over the follow-up period, mean time in the glucose concentration range of 70-180 mg/dL (3·9-10·0 mmol/L) was 791 min per day (SD 157) in the CGM plus CSII group and 741 min per day (225) in the CGM plus MDI group (adjusted mean treatment group difference: 83 min, 95% CI 17-149; p=0·01). Participants in the CGM plus CSII group had a greater reduction in CGM-measured mean glucose (p=0·005) and hyperglycaemia (on four metrics: p=0·007 for >180 mg/dL [>10·0 mmol/L], p=0·02 for >250 mg/dL [>13·9 mmol/L], p=0·04 for >300 mg/dL [>16·6 mmol/L], and p=0·02 for the area under the curve for 180 mg/dL [10·0 mmol/L]), but also an increase in CGM-measured hypoglycaemia (p=0·0001 for
Our findings show that glycaemic control measured by time in the glucose range of 70-180 mg/dL (3·9-10·0 mmol/L) is improved by initiation of CSII in adults with type 1 diabetes. However, biochemical hypoglycaemia also was increased in the study, which will be important to consider when incorporating these results into clinical practice.
AUTHORS: Fisher L, Hessler D, Polonsky W, Strycker L, Guzman S, Bowyer V, Blumer I, Masharani U.
DATE: July 08, 2017
OBJECTIVE: To demonstrate how maladaptive emotion regulation (ER) can lead to diabetes distress (DD), with subsequent effects on management and metabolic outcomes among adults with type 1 diabetes.
METHODS: Data are based on pre-intervention assessment for a random controlled trial to reduce DD. Patients were recruited in California, Oregon, Arizona and Ontario, Canada. After screening and consent, patients completed an online assessment and released their most recent laboratory HbA1C. Structural equation modeling was used to define an ER measurement model and test for significant pathways.
RESULTS: Three ER mechanisms combined into a single construct: emotion processing, non-judgment of emotions, non-reactivity to emotions. Models indicated a significant pathway from ER and cognitions to DD to disease management to metabolic control.
CONCLUSIONS: As hypothesized, the three ER mechanisms formed a single, coherent ER construct. Patients with poor ER reported high DD; and high DD was linked to poor diabetes management and poor metabolic control.
PRACTICE IMPLICATIONS: Identifying both the level of DD and the ER mechanisms that lead to high DD should be explored in clinical settings. Helping T1Ds to become more aware, less judgmental and less reactive behaviorally to what they feel about diabetes and its management may reduce DD.
AUTHORS: Schnell O, Barnard K, Bergenstal R, Bosi E, Garg S, Guerci B, Haak T, Hirsch IB, Ji L, Joshi SR, Kamp M, Laffel L, Mathieu C, Polonsky WH, Snoek F, Home P
DATE: July, 2017
Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research.
AUTHORS: Hessler DM, Fisher L, Polonsky WH, Masharani U, Strycker LA, Peters AL, Blumer I, Bowyer V
DATE: June 18, 2017
AIM:To determine the cross-sectional and longitudinal associations between diabetes distress and diabetes management.
METHODS: In a non-interventional study, 224 adults with Type 1 diabetes were assessed for diabetes distress, missed insulin boluses, hypoglycaemic episodes, and HbA1c at baseline and 9 months.
RESULTS: At baseline, greater distress was associated with higher HbA1c and a greater percentage of missed insulin boluses. Longitudinally, elevated baseline distress was related to increased missed insulin boluses, and decreases in distress were associated with decreases in HbA1c . In supplementary analyses, neither depression symptoms nor a diagnosis of major depressive disorder was associated with missed insulin boluses, HbA1c or hypoglycaemic episodes in cross-sectional or longitudinal analyses.
CONCLUSIONS: Significant cross-sectional and longitudinal associations were found between diabetes distress and management; in contrast, no parallel associations were found for major depressive disorder or depression symptoms. Findings suggest that elevated distress may lead to more missed insulin boluses over time, suggesting a potential intervention target. The covarying association between distress and HbA1c points to the complex and likely interactive associations between these constructs. Findings highlight the need to address distress as an integral part of diabetes management in routine care.
AUTHORS: Polonsky WH, Capehorn M, Belton A, Down S, Alzaid A, Gamerman V, Nagel F, Lee J, Edelman S
DATE: May, 2017
AIM: To investigate patient experiences during the diagnosis of type 2 diabetes mellitus (T2DM), focusing on how physician-patient communication at diagnosis influences patients’ psychosocial stress and subsequent self-management and outcomes.(T1D).
METHODS: We surveyed adults with T2DM in 26 countries in a large cross-national study of physician-patient communication during early T2DM treatment (IntroDia®). The self-report questionnaire assessed retrospectively patient experiences during diagnosis conversations (focusing on 43 possible conversational elements, and communication quality) and potential effects on patient-reported outcomes.
RESULTS: Data from 3628 people with T2DM who had been prescribed oral treatment at diagnosis were analysed. Exploratory factor analyses of the conversational elements yielded four coherent, meaningful factors: Encouraging (Cronbach’s α=0.86); Collaborative (α=0.88); Recommending Other Resources (α=0.75); and Discouraging (α=0.72). Patient-perceived communication quality (PPCQ) at diagnosis was positively associated with Encouraging (β=+1.764, p<0.001) and Collaborative (β=+0.347, p<0.001), negatively associated with Discouraging (β=-1.181, p<0.001) and not associated with Recommending Other Resources (β=+0.087, p=0.096), using a stable path model. PPCQ was associated with less current diabetes distress, greater current well-being and better current self-care. Conversation elements comprising factors associated with better PPCQ (Encouraging and Collaborative) were recalled more frequently by patients than elements associated with poor PPCQ (Discouraging).
CONCLUSIONS: Better physician-patient communication at T2DM diagnosis may contribute to subsequent greater patient well-being and self-care, and may be enhanced by greater physician use of Collaborative and Encouraging conversation elements.
AUTHORS: Brunton SA, Polonsky WH.
DATE: April, 2017
The importance of treatment adherence is well established, as poor adherence contributes to disease progression and increased morbidity and mortality. Analysis of 11,272 veterans with T2DM with a mean follow-up of 5 years showed that for each 10% increase in the medication possession ratio, the mean glycated hemoglobin (HbA1c) decreased by 0.24%. Poor adherence also leads to increased health care resource utilization and costs, including more frequent hospitalizations. Conversely, while improved adherence increases medication costs, it can decrease overall health care resource utilization and costs. Improved medication adherence also contributes to improvement in diabetes-related quality of life.
AUTHORS: Fisher L, Tang T, Polonsky W
DATE: April, 2017
The rapid development of new medications and devices in diabetes research and clinical care has led to an increased need to assess their impact on health-related quality of life (HRQOL). Unfortunately, the lack of consensus definitions and guidelines has led to the use of HRQOL measures that are often imprecise and inappropriate. The goal of this report is to provide a practical structure to the definition and measurement of HRQOL in diabetes research and clinical care. Following a brief historical background to provide context, we define HRQOL and provide a three-step framework for scale selection: identify the specific, proximal intervention targets; decide how reaching these targets will affect HRQOL; and select appropriate measures based on sample diversity, the intervention and the targets using a 2×2 grid (generic vs. diabetes specific measures; global vs. component measures). Practical tips for scale selection include: gaining patient input to document important potential HRQOL effects, varying scale selection by patient characteristics, considering common HRQOL measurement problems, and considering the timing of HRQOL assessment. We emphasize the importance of a careful, planned evaluation of HRQOL in diabetes, rather than an “off the shelf” approach.
AUTHORS: Tang TS, Yusuf FLA, Polonsky WH, Fisher L
DATE: April, 2017
A growing number of instruments measuring diabetes-specific health-related quality of life (HRQOL) have been identified in previous systematic reviews, the most recent being published in 2008. The purpose of this paper is report on an updated systematic review of diabetes-specific HRQOL measures highlighting the time period 2006-2016; to deconstruct existing diabetes-specific HRQOL measures into a simple framework for evaluating the goodness-of-fit between specific research needs and instrument characteristics; and to present core characteristics of measures not yet reported in other reviews to further facilitate scale selection. Using the databases Medline, Pubmed, CINAHL, OVID Embase, and PsycINFO, we identified 20 diabetes-specific HRQOL measures that met our inclusion criteria. For each measure, we extracted eight core characteristics for our measurement selection framework. These characteristics include target population (type 1 vs. type 2), number and type of HRQOL dimensions measured and scored, type of score and calculation algorithm, sensitivity to change data reported in subsequent studies, number of survey items, approximate time length to complete, number of studies using the instrument in the past 10years, and specific languages instruments is translated. This report provides a way to compare and contrast existing diabetes-specific HRQOL measures to aid in appropriate scale selection and utilization.
AUTHORS: Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group.
DATE: April 7, 2017
OBJECTIVE: Continuous glucose monitoring (CGM) improves glycemic control, but data are inconclusive about its influence on quality of life (QOL). We investigated the impact of 24 weeks of CGM use on QOL in adults with type 1 diabetes (T1D) who use multiple daily insulin injections.
RESEARCH DESIGN AND METHODS: DIAMOND was a prospective randomized trial that assessed CGM versus self-monitoring of blood glucose (SMBG) only in 158 adults with poorly controlled T1D. At baseline and study end, participants completed QOL measures that assessed overall well-being (WHO-5), health status (EQ-5D-5L), diabetes distress (DDS), hypoglycemic fear (worry subscale of the HFS-II), and hypoglycemic confidence (HCS). At study end, CGM participants completed the CGM Satisfaction Survey. Linear regression analyses compared treatment group changes in QOL outcomes over time. Associations between CGM satisfaction and change in QOL outcomes and in glycemic control indices were assessed.
RESULTS: The CGM group demonstrated a greater increase in hypoglycemic confidence (P = 0.01) and a greater decrease in diabetes distress (P = 0.01) than the SMBG group. No significant group differences in well-being, health status, or hypoglycemic fear were observed. CGM satisfaction was not significantly associated with glycemic changes but was associated with reductions in diabetes distress (P < 0.001) and hypoglycemic fear (P = 0.02) and increases in hypoglycemic confidence (P < 0.001) and well-being (P = 0.01).
CONCLUSIONS: CGM contributes to significant improvement in diabetes-specific QOL (i.e., diabetes distress, hypoglycemic confidence) in adults with T1D, but not with QOL measures not specific to diabetes (i.e., well-being, health status). CGM satisfaction was associated with most of the QOL outcomes but not with glycemic outcomes.
STUDY TITLE: Improved treatment satisfaction in patients with type 1 diabetes treated with insulin glargine 100U/mL versus neutral protamine Hagedorn insulin: An exploration of key predictors from two randomized controlled trials
AUTHORS: Polonsky W, Traylor L, Gao L, Wei W, Ameer B, Stuhr A, Vlajnic A.
DATE: March, 2017
AIM: Investigate contributors to treatment satisfaction in type 1 diabetes (T1D).
METHODS: Post-hoc analysis using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) in 771 T1D patients from two 28-week trials comparing once-daily insulin glargine 100U/mL (Gla-100) with once- or twice-daily NPH neutral protamine Hagedorn (NPH) insulin.
RESULTS: Gla-100 was associated with a significant improvement in treatment satisfaction versus NPH (overall population adjusted mean [standard error] DTSQs change from baseline: +1.13 [0.30] versus -0.04 [0.31]; p=0.006). In the overall population, treatment satisfaction improvement with all insulin regimens was related to less frequent severe hypoglycemia (coefficient-0.077; p=0.040) and HbA1c reduction (-0.066; p=0.082). By treatment regimen, relationships between treatment satisfaction and these outcomes approached or attained statistical significance for NPH insulin, but not Gla-100. In the overall population, predictors of treatment satisfaction improvement included: Gla-100 treatment (estimate 1.17, p=0.006), lower baseline DTSQs (-0.57, p<0.001), study (-1.01, p=0.019), lower severe hypoglycemia rate (0.17, p=0.012), and higher baseline HbA1c (0.44, p=0.014). By treatment regimen, these predictors remained significant for NPH insulin.
CONCLUSIONS: Gla-100 resulted in a significant improvement in treatment satisfaction versus NPH insulin, independent of baseline disease characteristics and clinical outcomes.
AUTHORS: Matza LS, Stewart KD, Davies EW, Hellmund R, Polonsky WH, Kerr D.
DATE: March, 2017
BACKGROUND: Glucose monitoring is important for patients with diabetes treated with insulin. Conventional glucose monitoring requires a blood sample, typically obtained by pricking the finger. A new sensor-based system called “flash glucose monitoring” monitors glucose levels with a sensor worn on the arm, without requiring blood samples.
OBJECTIVES: To estimate the utility difference between these two glucose monitoring approaches for use in cost-utility models.
METHODS:In time trade-off interviews, general population participants in the United Kingdom (London and Edinburgh) valued health states that were drafted and refined on the basis of literature, clinician input, and a pilot study. The health states had identical descriptions of diabetes and insulin treatment, differing only in glucose monitoring approach.
RESULTS: A total of 209 participants completed the interviews (51.7% women; mean age = 42.1 years). Mean utilities were 0.851 ± 0.140 for conventional monitoring and 0.882 ± 0.121 for flash monitoring (significant difference between the mean utilities; t = 8.3; P < 0.0001). Of the 209 participants, 78 (37.3%) had a higher utility for flash monitoring, 2 (1.0%) had a higher utility for conventional monitoring, and 129 (61.7%) had the same utility for both health states.
CONCLUSIONS: The flash glucose monitoring system was associated with a significantly greater utility than the conventional monitoring system. This difference may be useful in cost-utility models comparing the value of glucose monitoring devices for patients with diabetes. This study adds to the literature on treatment process utilities, suggesting that time trade-off methods may be used to quantify preferences among medical devices.
AUTHORS: Polonsky WH, Fisher L, Hessler D, Edelman SV.
DATE: February, 2017
BACKGROUND: While research designed to understand the concerns about hypoglycemia among patients with diabetes has been primarily focused on the investigation of fear and anxiety, recent evidence suggests a potentially important and conceptually distinct element-hypoglycemic confidence. To investigate this dimension, we developed the Hypoglycemic Confidence Scale (HCS); herein, we describe the construction and validation of the HCS and examine how key patient factors are associated with hypoglycemic confidence.
METHODS: Items were developed from interviews with six type 1 diabetes (T1D) adults, six insulin-using type 2 diabetes (T2D) adults, and seven diabetes healthcare professionals, resulting in nine self-report items. Separate exploratory factor analyses (EFAs) were conducted with T1D adults (N = 326), with T2D adults using both basal and prandial insulins (T2D-BP, N = 145) and with T2D adults using only basal insulin (T2D-BO, N = 82). Construct validity for the HCS was established with overall well-being (World Health Organization-5), diabetes distress (Diabetes Distress Scale), global anxiety (Generalized Anxiety Disorder), hypoglycemic fear (Hypoglycemic Fear Survey-II), and glycemic control (self-reported A1C). Hierarchical regression analyses examined the unique contribution of HCS scores, independent of hypoglycemic fear, on key psychosocial constructs and A1C.
RESULTS: EFAs of the nine HCS items yielded a single factor solution for each of the three subject samples, accounting for 50.8%, 65.1%, and 73.7% of the variance for the T1D, T2D-BP, and T2D-BO groups, respectively. Construct validity was established by significant correlations with criterion variables. The HCS was associated with well-being and diabetes distress in the T1D (in both cases, P < 0.001) and T2D-BP groups (in both cases, P < .05) and for self-reported A1C in the T2D-BP group (P < .05) independent of hypoglycemic fear.
CONCLUSIONS: Hypoglycemic confidence is a unique dimension of patient experience, different from hypoglycemic fear, and is deserving of further study. The HCS is a reliable valid measure of hypoglycemic confidence for adults with T1D and insulin-using T2D.
AUTHORS: Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group.
DATE: January, 2017
IMPORTANCE: Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection.
OBJECTIVE: To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections.
DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9%.
INTERVENTIONS: Random assignment 2:1 to CGM (n = 105) or usual care (control group; n = 53).
MAIN OUTCOMES AND MEASURES: Primary outcome measure was the difference in change in central-laboratory-measured HbA1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70 mg/dL, measured with CGM for 7 days at 12 and 24 weeks.
RESULTS: Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44% women; mean baseline HbA1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA1c reduction from baseline was 1.1% at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5% and 0.4%, respectively, in the control group (repeated-measures model P < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was -0.6% (95% CI, -0.8% to -0.3%; P < .001). Median duration of hypoglycemia at less than
CONCLUSIONS AND RELEVANCE: Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects.
STUDY TITLE: Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial
AUTHORS: Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Ólafsdóttir AF, Frid A, Wedel H, Ahlén E, Nyström T, Hellman J.
DATE: January 24, 2017
IMPORTANCE: The majority of individuals with type 1 diabetes do not meet recommended glycemic targets.
OBJECTIVE: To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections.
DESIGN, SETTING, AND PARTICIPANTS: Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at least 7.5% (58 mmol/mol) treated with multiple daily insulin injections.
INTERVENTIONS: Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks.
MAIN OUTCOMES AND MEASURES: Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied.
RESULTS: Among 161 randomized participants, mean age was 43.7 years, 45.3% were women, and mean HbA1c was 8.6% (70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA1c was 7.92% (63 mmol/mol) during continuous glucose monitoring use and 8.35% (68 mmol/mol) during conventional treatment (mean difference, -0.43% [95% CI, -0.57% to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P < .001). Of 19 secondary end points comprising psychosocial and various glycemic measures, 6 met the hierarchical testing criteria of statistical significance, favoring continuous glucose monitoring compared with conventional treatment. Five patients in the conventional treatment group and 1 patient in the continuous glucose monitoring group had severe hypoglycemia. During washout when patients used conventional therapy, 7 patients had severe hypoglycemia.
CONCLUSIONS AND RELEVANCE: Among patients with inadequately controlled type 1 diabetes treated with multiple daily insulin injections, the use of continuous glucose monitoring compared with conventional treatment for 26 weeks resulted in lower HbA1c. Further research is needed to assess clinical outcomes and longer-term adverse effects.
AUTHORS: Trief PM, Fisher L, Sandberg J, Cibula DA, Dimmock J, Hessler DM, Forken P, Weinstock RS..
DATE: December, 2016
OBJECTIVE: To compare glycemic control and secondary outcomes of a 4-month telephonic couples behavioral intervention to individual intervention, and to education, for adults with type 2 diabetes.
RESEARCH AND DESIGN METHODS: A randomized trial with the following three arms: couples calls (CC) (n = 104); individual calls (IC) (n = 94); and diabetes education (DE) (n = 82). All arms had self-management education (two calls). CC and IC had 10 additional behavior change calls. CC addressed collaboration and relationships/communication. Participants consisted of 280 couples, among whom one partner had type 2 diabetes and an A1C level ≥7.5%. Blinded assessments occurred at 4, 8, and 12 months. The primary outcome was change in A1C; and secondary outcomes were BMI, waist circumference, blood pressure, depressive symptoms, diabetes self-efficacy, and diabetes distress.
RESULTS: Patients had a mean age of 56.8 years; 61.6% were male, and 30.4% were minorities. The baseline mean A1C level was 9.1%. Intention-to-treat analyses found significant A1C reductions for all (12 months: CC -0.47%, IC -0.52%, DE -0.57%), with no differences between arms. Preplanned within-arm analyses were stratified by baseline A1C tertiles: lowest tertile (7.5-8.2%), no change from baseline; middle tertile (8.3-9.2%), only CC led to significantly lower A1C level; and highest tertile (≥9.3%), significant improvement for all interventions. For BMI, CC showed significant improvement, and CC and DE led to decreased waist circumference. The IC group showed greater blood pressure improvement. Results for secondary psychosocial outcomes favored the CC group.
CONCLUSIONS: In adults with poorly controlled type 2 diabetes, a collaborative couples intervention resulted in significant, lasting improvement in A1C levels, obesity measures, and some psychosocial outcomes. For those with exceedingly high A1C levels, education alone was beneficial, but additional intervention is needed to achieve glycemic targets.
AUTHORS: Polonsky, WH., Hessler, D., Layne, JE., Zisser, H.
DATE: September 27, 2016
BACKGROUND: Few recent studies have examined the impact of continuous subcutaneous insulin infusion systems on patient-reported quality of life (QOL). We explored QOL changes resulting from treatment with the Omnipod® Insulin Management System (Insulet Corp., Billerica, MA).
METHODS: One thousand two hundred forty-five adults (>18 years) with type 1 diabetes and current Omnipod users completed an online questionnaire examining perceived changes in QOL and glycemic control since Omnipod initiation. The QOL dimensions included overall well-being (World Health Organization-5, modified to examine changes retrospectively), diabetes distress (Type 1 Diabetes Distress Scale, current distress and a modified retrospective version), and psychosocial impact (two subscales from the Diabetes Technology Impact Measure, perceived control over diabetes, and hypoglycemic safety). Regression analyses examined associations between demographics, key psychological factors, and perceived change in glycemic control with the QOL dimensions.
RESULTS: Broad QOL and clinical benefits associated with Omnipod use were common. The majority reported positive changes in the following: overall well-being (53.5%), perceived control over diabetes (72.5%), hypoglycemic safety (50.6%), and diabetes distress (69.6%). Worsening in any of these areas was uncommon. In addition, 64.2% of patients reported glycemic improvement post-Omnipod initiation, while 35.2% reported a decrease in severe hypoglycemic episodes. Trust in one’s Omnipod, perceived improvement in glycemic control, and reductions in severe hypoglycemia independently predicted benefits in all QOL measures (all P < 0.001).
CONCLUSIONS: These findings suggest that Omnipod users perceived substantial QOL benefits from the device; benefits are more apparent in those who trust the device and have noted positive changes in glycemic control.
AUTHORS: Linetzky, B., Jiang, D., Funnell, MM., Curtis, BH., Polonsky, WH.
DATE: August 17, 2016
BACKGROUND: The 2-year prospective MOSAIc (Multinational Observational Study assessing Insulin use: understanding the challenges associated with progression of therapy) study is investigating whether patient-, physician-, and health system-related factors affect outcomes in patients with type 2 diabetes (T2D). This baseline subanalysis investigated how aspects of the patient–physician relationship are associated with diabetes-related distress, insulin adherence, and glycemic control.
METHODS: Patients with T2D taking insulin for ≥3 months were recruited at primary care and specialty practice sites in 18 countries. Physicians provided usual care. Clinical history and most recent HbA1c values were collected; patients were surveyed regarding their perception of physician interactions, diabetes-related distress level, and insulin adherence.
RESULTS: The analysis population comprised 4341 patients. Four (of six) domains showed a significant relationship with total diabetes-related distress (P < 0.01). Poor insulin adherence was associated with greater diabetes-related distress (adjusted odds ratio [aOR] 1.14; 95% confidence interval [CI] 1.06–1.22), higher Discrimination (aOR 1.13; 95% CI 1.02–1.27) and Hurried Communication (aOR 1.35; 95% CI 1.20–1.53) scores, and a lower Explained Results score (aOR 0.86; 95% CI 0.77–0.97). Poor insulin adherence was associated with a 0.43% increase in HbA1c, whereas a 1-unit increase in total diabetes-related distress and Hurried Communication scores was associated with a 0.171% and 0.145% increase in HbA1c, respectively.
CONCLUSIONS: Patients distressed about living with T2D, and dissatisfied with aspects of their interactions with physicians, exhibited poor insulin adherence. Perceived physician inattention and lack of engagement (and diabetes-related distress) directly affect insulin adherence and glycemic control.
AUTHORS: Polonsky, WH., Henry, RR.
DATE: July 22, 2016
At least 45% of patients with type 2 diabetes (T2D) fail to achieve adequate glycemic control (HbA1c <7%). One of the major contributing factors is poor medication adherence. Poor medication adherence in T2D is well documented to be very common and is associated with inadequate glycemic control; increased morbidity and mortality; and increased costs of outpatient care, emergency room visits, hospitalization, and managing complications of diabetes. Poor medication adherence is linked to key nonpatient factors (eg, lack of integrated care in many health care systems and clinical inertia among health care professionals), patient demographic factors (eg, young age, low education level, and low income level), critical patient beliefs about their medications (eg, perceived treatment inefficacy), and perceived patient burden regarding obtaining and taking their medications (eg, treatment complexity, out-of-pocket costs, and hypoglycemia). Specific barriers to medication adherence in T2D, especially those that are potentially modifiable, need to be more clearly identified; strategies that target poor adherence should focus on reducing medication burden and addressing negative medication beliefs of patients. Solutions to these problems would require behavioral innovations as well as new methods and modes of drug delivery.
AUTHORS: Polonsky, WH., Peters, AL., Hessler, D.
DATE: June 28, 2016
BACKGROUND: Older adults with type 1 diabetes (T1D) or insulin-using type 2 diabetes (iT2D) are at high risk for severe hypoglycemic episodes. Real-time continuous glucose monitoring (RT-CGM) in this population may reduce this risk, but when patients switch to Medicare at age 65, RT-CGM is no longer a covered benefit. We developed a survey to examine health and quality of life (QOL) benefits of RT-CGM in seniors (age ≥ 65).
METHODS: Two groups of seniors with T1D or iT2D-current RT-CGM users (n = 210) and RT-CGM “hopefuls” (patients who wanted but could not obtain RT-CGM due to lack of insurance coverage; n = 75)-completed an online survey. The survey examined history of hypoglycemic experiences as well as current quality of life (QOL), including generic and diabetes-specific measures.
RESULTS: Current users reported fewer moderate (P < .01) and fewer severe hypoglycemic episodes (P < .01) over the past 6 months than “hopefuls” and greater reductions over time in hypoglycemic events requiring the assistance of another, ER visits, and paramedic visits to the home (in all cases, P < .01). Regarding QOL, current users reported significantly better well-being (P < .001), less hypoglycemic fear (P < .05), and less diabetes distress (P < .05) than “hopefuls.”
CONCLUSIONS: These data suggest that RT-CGM use in seniors is associated with reductions in episodes of severe hypoglycemia and improved QOL, suggesting that restrictive access to RT-CGM in the Medicare age population may have deleterious health, economic, and QOL consequences.
STUDY TITLE: Design and Methods of a Randomized Trial of Continuous Glucose Monitoring in Persons With Type 1 Diabetes With Impaired Glycemic Control Treated With Multiple Daily Insulin Injections (GOLD Study)
AUTHORS: Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Pehrsson NG, Moström P.
DATE: May 3, 2016
BACKGROUND: The majority of individuals with type 1 diabetes today have glucose levels exceeding guidelines. The primary aim of this study was to evaluate whether continuous glucose monitoring (CGM), using the Dexcom G4 stand-alone system, improves glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections (MDI).
METHODS: Individuals with type 1 diabetes and inadequate glycemic control (HbA1c ≥ 7.5% = 58 mmol/mol) treated with MDI were randomized in a cross-over design to the Dexcom G4 versus conventional care for 6 months followed by a 4-month wash-out period. Masked CGM was performed before randomization, during conventional treatment, and during the wash-out period to evaluate effects on hypoglycemia, hyperglycemia, and glycemic variability. Questionnaires were used to evaluate diabetes treatment satisfaction, fear of hypoglycemia, hypoglycemia confidence, diabetes-related distress, overall well-being, and physical activity during the different phases of the trial. The primary endpoint was the difference in HbA1c at the end of each treatment phase.
RESULTS: A total of 205 patients were screened, of whom 161 were randomized between February and December 2014. Study completion is anticipated in April 2016.
CONCLUSIONS: It is expected that the results of this study will establish whether using the Dexcom G4 stand-alone system in individuals with type 1 diabetes treated with MDI improves glycemic control, reduces hypoglycemia, and influences quality-of-life indicators and glycemic variability.
AUTHORS: Fisher, L., Hessler, D., Polonsky, W., Strycker, L., Masharani, U., Peters, A.
DATE: April 4, 2016
AIMS: To document the prevalence and 9-month incidence of elevated diabetes distress (DD) and the stability of DD over time using both single threshold and minimal clinically important differences (MCID) approaches.
METHODS: Adults with type 1 diabetes (T1D) (N=224) completed the 28-item T1-Diabetes Distress Scale (T1-DDS) at baseline and 9months. A T1-DDS threshold was identified with spline analysis and MCID was calculated from the standard error of measurement.
RESULTS: Analyses supported a cut-point of ≥2.0 for elevated DD. The prevalence and 9-month incidence of elevated DD was 42.1% and 54.4%, respectively. MCID was ±0.19 but varied by subscale (.26 to .50). Elevated DD was stable: only 20% crossed 2.0 over 9months. MCID analyses showed that change also occurred among those who remained either below or above 2.0 over time. Change varied by source of distress, with Powerlessness the most prevalent and stable. Using MCID, only participant age, gender and number of complications predicted change.
CONCLUSIONS: The prevalence, 9-month incidence and stability of elevated DD are high among adults with T1D, with change based on source of DD. We propose a combined cut-point/MCID framework for measuring change in DD, since each approach reflects unique characteristics of change over time.
AUTHORS: Weissberg-Benchell, J., Hessler, D., Polonsky, WH., Fisher, L.
DATE: March 17, 2016
BACKGROUND: The psychosocial impact of the bionic pancreas (BP) was assessed among children attending diabetes camp.
METHODS: Nineteen children were randomly assigned for 5 days to the BP condition and 5 days to the control condition in a crossover design.
RESULTS: Significant reductions in hypoglycemic fear and regimen burden were found. Children felt less burdened or worried about diabetes and felt freer to do things they enjoyed while using the BP. Children wished the BP responded to out of range numbers faster and expressed annoyance about carrying around the necessary equipment.
CONCLUSIONS: Children may experience improved psychosocial outcomes following use of BP while expressing key areas of user concern. Future studies in less controlled environments with larger sample sizes can determine if these findings are generalizable to other groups.
AUTHORS: Hessler, D., Fisher, L., Polonsky, W., Johnson, N.
DATE: February 10, 2016
OBJECTIVE: To identify the unique areas of diabetes-related distress (DD) for parents of teens with type 1 diabetes and parent and teen characteristics associated with DD.
METHODS: Areas of DD were developed from structured interviews and translated into 46 survey items. Items were analyzed with exploratory factor analysis (EFA).
RESULTS: An EFA with 332 parents (88% mothers) reduced items to four Parent Diabetes Distress Scale (PDDS) factors (20 items, α = .94): Personal, Teen Management, Parent/Teen Relationship, and Healthcare Team Distress. Parent DD was higher among fathers, younger or single parents, parents of teens with higher hemoglobin A1c or severe low blood glucose levels, authoritarian parenting, depressive symptoms, and low emotional support.
CONCLUSIONS: 4 areas of parent DD were identified using a newly developed measure, the PDDS. DD was associated with family demographic, teen diabetes status, and parent contextual factors, and can help identify parents who may be more vulnerable to DD.
AUTHORS: Polonsky, WH., Fisher, L., Hessler, D., Johnson, N.
DATE: February 9, 2016
BACKGROUND: Although the widespread prevalence of diabetes-related distress (DD) in adults with type 1 diabetes (T1D) has been well established, there has been little inquiry into the experiences of their spouse/partners. Therefore the goal of this study was to investigate the prevalence and sources of DD in the spouses and partners of adults with T1D (“T1D partner”) and to examine the associations of DD in this population with key demographic and contextual factors.
MATERIALS AND METHODS: Qualitative interviews with 11 T1D partners led to the development of 44 DD survey items, which were examined by exploratory factor analysis (EFA). Regression models examined associations of the resulting DD scales with four groups of variables: partner demographics and contextual variables, as well as person with diabetes (PWD) demographics, diabetes status, and behavioral factors.
RESULTS: EFA with 317 T1D partners yielded a 22-item scale with four factors: Hypoglycemia Distress, Emotional Distress, Management Distress, and Role Distress. All scales were significantly correlated with the three criterion variables (depression, general life stress, and diabetes-related relationship satisfaction), suggesting satisfactory concurrent validity. High DD was most common for Hypoglycemic Distress (64.4% of the sample) and least common for Management Distress (28.4%). Greater DD was significantly and independently linked with being younger, female, greater involvement in the PWD’s diabetes management, lower levels of relationship satisfaction, less trusting of the PWD’s physician, poorer PWD glycemic control, and more frequent hypoglycemic episodes. T1D partners also reported low levels of diabetes-related support from all sources.
CONCLUSIONS: Four sources of partner DD were identified. Results suggest that DD in T1D partners is common, especially distress associated with hypoglycemia. Predictors of T1D partner DD come from multiple sources: demographic, disease-related, and contextual arenas, all pointing to opportunities for acknowledging and addressing DD directly in this population.
AUTHORS: Fisher, L., Hessler, DM., Polonsky, WH., Masharani, U., Peters, AL., Blumer, I., Strycher, LA.
DATE: January 5, 2016
AIMS: To determine the prevalence of depression and diabetes distress in adults with Type 1 diabetes and the rate of false-positives when compared with rates of major depressive disorder.
METHODS: The sample consisted of 368 individuals with Type 1 diabetes, aged > 19 years. Individuals completed: the eight-item Patient Health Questionnaire depression scale, which was coded using four scoring criteria (scores > 10, >12 and >15, and Diagnostic and Statistical Manual of Mental Disorders-5 algorithm scores); the Type 1 Diabetes Distress Scale; and the Structured Clinical Interview for DSM Disorders to assess major depressive disorder, where ‘DSM disorders’ refers to disorders defined according to the Diagnostic and Statistical Manual of Mental Disorders.
RESULTS: The prevalence rates of depression according to the eight-item Patient Health Questionnaire were: score >10, 11.4%; score >12, 7.1%; score >15, 3.8%; and positive algorithm result, 4.6%. The prevalence of major depressive disorder was 3.5%; and the prevalence of at least moderate diabetes distress was 42.1%. Depending on the criterion used, the false-positive rate when using the Patient Health Questionnaire compared with the results when using the Structured Clinical Interview for DSM Disorders varied from 52 to 71%. Of those classified as depressed on the PHQ-8 or Structured Clinical Interview for DSM Disorders, between 92.3 and 96.2% also reported elevated diabetes distress. No significant association between any group classed as having depression according to the Patient Health Questionnaire or the Structured Clinical Interview for DSM Disorders and HbA1c concentration in that group was found. Depression was significantly associated with more ‘other’ life stress, more complications and a lower level of education.
CONCLUSIONS: We found an unexpectedly low rate of current depression and major depressive disorder in this diverse sample of adults with Type 1 diabetes, and a very high rate of false-positive results using the Patient Health Questionnaire. Considering the high prevalence of diabetes distress, much of what has been considered depression in adults with Type 1 diabetes may be attributed to the emotional distress associated with managing a demanding chronic disease and other life stressors and not necessarily to underlying psychopathology. This article is protected by copyright. All rights reserved.
AUTHORS: Polonsky, WH., Fisher, L., Hessler, D., Edelman, SV.
DATE: Nov-Dec. 2015
AIMS: To identify the hypoglycemic concerns of adults with type 2 diabetes (T2D) and examine how these concerns are associated with key patient characteristics.
METHODS: Qualitative interviews with 16 T2D adults and 11 diabetes care providers were conducted. Survey items were then developed and submitted to exploratory factor analyses (EFAs). Construct validity was assessed by correlations with diabetes distress, anxiety and depressive symptoms, well-being, hypoglycemic fear, hypoglycemia history and glycemic control (A1C).
RESULTS: An EFA with 226 insulin users and 198 non-insulin users yielded 3 factors (14 items): Hypoglycemia Anxiety, Avoidance and Confidence. For both T2D groups, higher Anxiety and Avoidance were significantly associated with more hypoglycemia, lower well-being, and greater diabetes distress, depressive symptoms and hypoglycemic fear. Similar associations, in the converse direction, were found for Confidence. Among insulin users only, Anxiety was independently associated with greater emotional distress and more hypoglycemia, while Confidence was independently linked to less emotional distress and lower A1C. Avoidance was independently associated with greater emotional distress in both groups.
CONCLUSIONS: Using the new 14-item Hypoglycemic Attitudes and Behavior Scale (HABS), we found that hypoglycemic concerns are significant in T2D adults, are linked to emotional distress and A1C, and merit attention in clinical practice.
AUTHORS: Polonsky, WH., Fisher, L., Hessler, D., Edelman, SV.
DATE: November, 2015
BACKGROUND: Although many different types of insulin delivery devices are currently available, there is no well-accepted, validated method to assess patient satisfaction with these devices and their impact on quality of life and other patient-reported outcomes. To address this problem, we developed the Insulin Device Satisfaction Survey (IDSS) and herein describe its construction and validation. We then examine how key patient factors are associated with device satisfaction.
MATERIALS AND METHODS: Items were developed from interviews with adults with type 1 diabetes (T1D) (n=10) and type 2 diabetes (T2D) using insulin (n=10), as well as eight healthcare professionals, leading to an initial pool of 32 items. Separate exploratory factor analyses (EFAs) were conducted with T1D subjects (n=279) and insulin-using T2D subjects (n=209). Construct validity was established with overall well-being (World Health Organization-5), diabetes distress (Diabetes Distress Scale), diabetes self-efficacy (Self-Efficacy for Diabetes Management Scale), and subscales from the Insulin Delivery System Rating Questionnaire. Regression analyses examined associations between total scale satisfaction and demographics, insulin adherence, clinical indicators, and device type (pump vs. nonpump users).
RESULTS: The two EFAs resulted in a 14-item scale for T1D subjects and a 12-item scale for T2D subjects, with eight items common across both samples. The EFAs yielded three coherent, meaningful factors in each sample, accounting for 55.6% (T1D sample) and 64.1% (T2D sample) of the variance. Validity was established by significant correlations with all criterion variables. For both samples, higher IDSS scores were significantly associated with better glycemic control and greater insulin adherence and pump use. For T2D subjects only, IDDS scores were significantly linked to fewer long-term complications, fewer low blood glucose readings, and older age.
CONCLUSIONS: The IDSS is a reliable, valid measure of insulin device satisfaction in both its T1D form and T2 form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.
AUTHORS: Polonsky, WH., Fisher, L.
DATE: August, 2015
Providing behavioral, biomarker, or disease risk feedback to patients is a key component of most behavioral interventions in diabetes, but it remains unclear what is necessary for such feedback to be truly engaging and effective. We sought to identify how personalized health-related feedback is most effectively designed and delivered, and how feedback may be tailored to meet the needs of individual patients with diabetes. To do so, we systematically reviewed recent findings concerning the effectiveness of feedback in eight health-related areas, including several specific to diabetes care (blood glucose monitoring and HbA1c) and others which touch on broader care dimensions (blood pressure, cholesterol, dietary intake, pedometer usage, self-weighing, and medical imaging). Five interdependent characteristics of health-related feedback were identified (clarity of the feedback message, personal meaningfulness of the feedback, frequency of feedback, guidance and support accompanying feedback, and interplay between feedback and patient characteristics) and applications for use in diabetes care were provided. Findings suggested that feedback will be most effective when it is easy for patients to understand and is personally meaningful, frequency of feedback is appropriate to the characteristics of the behavior/biomarker, guidance for using feedback is provided, and feedback is qualified by patient characteristics. We suggest that the effectiveness of feedback to promote better diabetes outcomes requires careful consideration of the feedback message, how it is delivered, and characteristics of the recipients.
AUTHORS: Polonsky, WH., Fisher, L., Hessler, D., Edelman, SV.
DATE: September, 2015
BACKGROUND: Many different devices are available to patients to measure glucose levels, but there is no validated method to assess treatment satisfaction with glucose monitoring devices and its impact on quality of life and other patient-reported outcomes. To address this problem, we developed the Glucose Monitoring System Satisfaction Survey (GMSS). We describe the construction and validation of the GMSS and examine how key patient factors are associated with glucose device satisfaction.
MATERIALS AND METHODS: Items were developed from interviews with 15 adults with either type 1 diabetes (T1D) or type 2 diabetes (T2D) and 10 diabetes healthcare professionals, resulting in an initial pool of 42 items. Separate exploratory factor analyses (EFAs) were conducted with adults with T1D (n=254) and with insulin-using T2D (n=206). Construct validity was established with overall well-being (World Health Organization-5), diabetes distress (Diabetes Distress Scale), attitudes toward glucose monitoring (Self-Monitoring of Blood Glucose Obstacles scale), and the previously validated Blood Glucose Monitoring System Rating Questionnaire. Regression analyses examined associations between total scale satisfaction and demographics, diabetes status, and glucose monitor use.
RESULTS: The two EFAs resulted in two 15-item scales, one for T1D and one for T2D, and yielded four coherent and meaningful factors in each sample: three factors with the same items in common for both samples (Emotional Burden, Behavioral Burden, and Openness) and a fourth factor unique to each sample (Trust for T1D, Worthwhileness for T2D). The final EFA accounted for 66.5% of the variance in the T1D sample and 67.0% in the T2D sample. Validity was established by significant correlations with criterion variables.
CONCLUSIONS: The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.
AUTHORS: Fisher, L., Polonsky, WH., Hessler, DM., Masharani, U., Blumer, I., Peters, AL., Strycher, LA., Bowyer, V.
DATE: May-June, 2015
AIMS: To identify the unique sources of diabetes distress (DD) for adults with type 1 diabetes (T1D).
METHODS: Sources of DD were developed from qualitative interviews with 25 T1D adults and 10 diabetes health care providers. Survey items were then developed and analyzed using both exploratory (EFA) and confirmatory CFA) analyses on two patient samples. Construct validity was assessed by correlations with depressive symptoms (PHQ8), complications, HbA1C, BMI, and hypoglycemia worry scale (HWS). Scale cut-points were created using multiple regression.
RESULTS: An EFA with 305 U.S. participants yielded 7 coherent, reliable sources of distress that were replicated by a CFA with 109 Canadian participants: Powerlessness, Negative Social Perceptions, Physician Distress, Friend/Family Distress, Hypoglycemia Distress, Management Distress, Eating Distress. Prevalence of DD was high with 41.6% reporting at least moderate DD. Higher DD was reported for women, those with complications, poor glycemic control, younger age, without a partner, and non-White patients.
CONCLUSIONS: We identified a profile of seven major sources of DD among T1D using a newly developed assessment instrument. The prevalence of DD is high and is related to glycemic control and several patient demographic and disease-related patient characteristics, arguing for a need to address DD in clinical care.
AUTHORS: Hessler, D., Fisher, L., Strycker, LA., Arean, PA., Bowyer, V.
DATE: May, 2015
AIMS: Diabetes regimen distress (RD) and depression are related constructs, however the nature of their relationship has not been explored over time, leading to difficulties differentiating between RD and depression and for selection of programs of care. We examined longitudinal associations between RD and depression to explicate the direction and mechanism of operation between these two constructs.
METHODS: 392 adults with type 2 diabetes participated in a randomized control trial (RCT) to reduce diabetes distress. Participants were assessed for RD and depression symptoms, using the PHQ-8, at baseline, and at 4 and 12 months. Latent growth curve models tested both predictive unidirectional and bidirectional longitudinal associations between changes in RD and depression.
RESULTS: Changes in RD did not significantly predict changes in PHQ-8, nor did changes in PHQ-8 predict changes in RD. A significant bidirectional association was found (Coefficient Estimate=.081, p=.001), where decreases in RD were associated with decreases in PHQ-8. The association was strongest among those with high baseline RD or PHQ-8 scores.
CONCLUSIONS: In the context of an RCT to reduce distress, support was found for a covarying association, in which changes in RD and depression symptoms occurred in tandem over time. No support was found for a causative association. Findings point to RD and depression containing properties that may be related to a shared underlying dimension of emotional distress. Results suggest consideration of both RD and depression in clinical decision making, with interventions selected based on source of distress.
AUTHORS: Fisher, L. Gonzalez, JS. , Polonsky, WH.
DATE: July, 2014
Studies have identified significant linkages between depression and diabetes, with depression associated with poor self-management behaviour, poor clinical outcomes and high rates of mortality. However, findings are not consistent across studies, yielding confusing and contradictory results about these relationships. We suggest that there has been a failure to define and measure ‘depression’ in a consistent manner. Because the diagnosis of depression is symptom-based only, without reference to source or content, the context of diabetes is not considered when addressing the emotional distress experienced by individuals struggling with diabetes. To reduce this confusion, we suggest that an underlying construct of ’emotional distress’ be considered as a core construct to link diabetes-related distress, subclinical depression, elevated depression symptoms and major depressive disorder (MDD). We view emotional distress as a single, continuous dimension that has two primary characteristics: content and severity; that the primary content of emotional distress among these individuals include diabetes and its management, other life stresses and other contributors; and that both the content and severity of distress be addressed directly in clinical care. We suggest further that all patients, even those whose emotional distress rises to the level of MDD or anxiety disorders, can benefit from consideration of the content of distress to direct care effectively, and we suggest strategies for integrating the emotional side of diabetes into regular diabetes care. This approach can reduce confusion between depression and distress so that appropriate and targeted patient-centred interventions can occur.
AUTHORS: Polonsky, WH. Fisher, L., Hessler, D., Edelman, SV.
DATE: January, 2014
AIMS: To identify patient-reported obstacles to self-monitoring of blood glucose among those with Type 2, both insulin users and non-insulin users, and to investigate how obstacles are associated with frequency of self-monitoring and use of self-monitoring data.
METHODS: Patients with Type 2 diabetes (n = 886, 65% insulin users) who attended a 1-day diabetes education conference in cities across the USA completed a survey on current and recommended self-monitoring of blood glucose frequency, how they used self-monitoring results and perceived obstacles to self-monitoring use. Exploratory factor analysis examined 12 obstacle items to identify underlying factors. Regression analyses examined associations between self-monitoring of blood glucose use and the key obstacle factors identified in the exploratory factor analysis.
RESULTS: Three obstacle factors emerged: Avoidance, Pointlessness and Burden. Avoidance was the only significant independent predictor of self-monitoring frequency (β = -0.23, P < 0.001). Avoidance (β = -0.12, P < 0.01) and Pointlessness (β = -0.15, P < 0.001) independently predicted how often self-monitoring data were shared with healthcare professionals and whether or not data were used to make management adjustments (Avoidance: odds ratio = 0.74, P < 0.001; Pointlessness: odds ratio = 0.75, P < 0.01). Burden was not associated with any of the self-monitoring behavioural measures. Few differences between insulin users and non-insulin users were noted.
CONCLUSIONS: Obstacles to self-monitoring of blood glucose use, both practical and emotional, were common. Higher levels of Avoidance and Pointlessness, but not Burden, were associated with less frequent self-monitoring use. Addressing patients’ self-monitoring-related emotional concerns (Avoidance and Pointlessness) may be more beneficial in enhancing interest and engagement with self-monitoring of blood glucose than focusing on day-to-day, behavioural issues (Burden).
AUTHORS: Schnell, O., Amann-Zalan, I., Jelsovsky, Z., Moritz, A., Bermejo, JL., Parkin, CG., Schweitzer, MA., Fisher, L., Polonsky, WH.
DATE: July, 2013
OBJECTIVE: The effect of therapeutic strategies on cardiovascular (CV) disease can be evaluated by monitoring changes in CV risk biomarkers. This study investigated the effect of a structured self-monitoring of blood glucose (SMBG) protocol and the resulting improvements in glycemic control on changes in high-sensitivity C-reactive protein (hs-CRP) in insulin-naïve patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS: The Structured Testing Program (STeP) study was a prospective, cluster-randomized, multicenter trial in which 483 poorly controlled, insulin-naïve patients with type 2 diabetes were randomized to active control (ACG) or structured testing (STG) that included quarterly structured SMBG. Changes in A1C, hs-CRP, and glycemic variability (STG subjects only) were measured at baseline and quarterly.
RESULTS: Reductions in geometric mean hs-CRP values were significantly greater in the STG group at months 3 (P = 0.005), 6 (P = 0.0003), and 12 (P = 0.04) than in the ACG group. STG patients at high CV risk (>3 mg/L) showed significantly greater reductions in hs-CRP levels than ACG patients at high CV risk: -3.64 mg/dL (95% CI -4.21 to -3.06) versus -2.18 mg/dL (-2.93 to -1.43), respectively (P = 0.002). There was a strong correlation between reductions in hs-CRP and A1C in both groups: standardized coefficient (β) was 0.25 for the entire cohort (P < 0.0001), 0.31 for STG (P < 0.0001), and 0.16 for ACG (P = 0.02).
CONCLUSIONS: Reductions in hs-CRP level are associated with reductions in A1C but not reductions in lipids or glycemic variability. Comprehensive structured SMBG-based interventions that lower A1C may translate into improvements in CV risk, as evidenced by levels of the biomarker hs-CRP..
STUDY TITLE: Self-monitoring of blood glucose in noninsulin-using type 2 diabetic patients: right answer, but wrong question: self-monitoring of blood glucose can be clinically valuable for noninsulin users
AUTHORS: Polonsky, WH., Fisher, L.
DATE: January, 2013
Given the importance of glycemic control in the development of diabetes complications, the plethora of tools now available to monitor the day-to-day trends in glycemia is remarkable. In this regard, self-monitoring of blood glucose (SMBG) has been considered a key component of patient management. Arguably, there remains almost universal agreement that SMBG should be available to all diabetic patients regardless of current treatment strategy. However, recently there have been reports that have challenged the current paradigm that all patients should use SMBG and concluded that SMBG for type 2 diabetic patients not on insulin may not be beneficial on glycemic control and must be weighed against the expense and inconvenience. In the counterpoint narrative following the contribution by Malanda et al., Drs. Polonsky and Fisher provide a compelling argument suggesting that while it is evident that implementing SMBG in unstructured ways without training patients and clinicians is likely to be a waste of resources, there are effective and powerful ways to use structured SMBG in insulin-naïve type 2 diabetic patients. -William T. Cefalu, MD Editor in Chief, Diabetes Care.
AUTHORS: Fisher, L., Polonsky, WH., Parkin, CG., Jelsovsky, Z., Petersen, B., Wagner, RS.
DATE: May, 2012
INTRODUCTION: Patients with T2DM often view self-monitoring of blood glucose (SMBG) as burdensome and pointless, which may affect their broader attitudes toward diabetes management. We examined how a structured SMBG protocol influenced diabetes self-efficacy and autonomous motivation over time, and linked these to changes in glycemic control.
MATERIALS AND METHODS: The Structured Testing Program (STeP) is a 12-month, two-arm, cluster-randomized trial that assessed the efficacy of structured SMBG in 483 insulin-naïve T2DM patients. Measures included: Confidence in Diabetes Self-Care for Type 2 patients (CIDS-T2), Diabetes-related Autonomous Motivation (DRAM), self-management behaviors and HbA1c.
RESULTS: Intent-to-treat (ITT) and per-protocol (PP) analyses showed significant increases in CIDS-T2 scores over time (main effects p<0.0001). PP analysis showed significant between-group differences (p<0.05), with adherent STG patients displaying greater CIDS-T2 improvement than ACG patients. PP analyses showed main and between-group effects in DRAM with similar findings. Changes in CIDS-T2 were related to HbA1c changes over time; no self-management variable mediated this relationship. CIDS-T2 and HbA1c displayed a significant time-concordant relationship.
DISCUSSION: Structured SMBG leads to significant increases in self-confidence and autonomous motivation associated with diabetes self-management. Changes in self-confidence are linked to changes in glycemic control and share a time-concordant relationship.
AUTHORS: Fisher, L., Hessler, DM., Polonsky, WH., Mullan, J.
DATE: February, 2012
OBJECTIVE: To identify the pattern of relationships between the 17-item Diabetes Distress Scale (DDS17) and diabetes variables to establish scale cut points for high distress among patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS: Recruited were 506 study 1 and 392 study 2 adults with type 2 diabetes from community medical groups. Multiple regression equations associated the DDS17, a 17-item scale that yields a mean-item score, with HbA(1c), diabetes self-efficacy, diet, and physical activity. Associations also were undertaken for the two-item DDS (DDS2) screener. Analyses included control variables, linear, and quadratic (curvilinear) DDS terms.
RESULTS: Significant quadratic effects occurred between the DDS17 and each diabetes variable, with increases in distress associated with poorer outcomes: study 1 HbA(1c) (P < 0.02), self-efficacy (P < 0.001), diet (P < 0.001), physical activity (P < 0.04); study 2 HbA(1c) (P < 0.03), self-efficacy (P < 0.004), diet (P < 0.04), physical activity (P = NS). Substantive curvilinear associations with all four variables in both studies began at unexpectedly low levels of DDS17: the slope increased linearly between scores 1 and 2, was more muted between 2 and 3, and reached a maximum between 3 and 4. This suggested three patient subgroups: little or no distress, <2.0; moderate distress, 2.0-2.9; high distress, ≥3.0. Parallel findings occurred for the DDS2.
CONCLUSIONS: In two samples of type 2 diabetic patients we found a consistent pattern of curvilinear relationships between the DDS and HbA(1c), diabetes self-efficacy, diet, and physical activity. The shape of these relationships suggests cut points for three patient groups: little or no, moderate, and high distress.
AUTHORS: Polonsky, WH., Fisher, L., Hessler, D., Edelman, SV.
DATE: November, 2011
OBJECTIVE: To survey the self-reported use of self-monitoring of blood glucose (SMBG) among patients with type 2 diabetes (T2DM), both insulin users (IUs) and non-insulin users (NIUs), in the United States and to examine: how often patients test; what SMBG instructions patients report receiving from their health care providers (HCPs); how the frequency of testing conforms with reported HCP recommendations for testing; and what is done with the results of testing. Differences between IUs and NIUs were also investigated.
METHODS: A convenience sample of 886 T2DM participants at a series of one-day conferences across the United States completed a survey on current and recommended SMBG frequency, how SMBG results were used, and how HCPs reportedly talked about SMBG issues with the patient. IUs (65% of the sample) and NIUs (35%) were examined separately.
RESULTS: IUs and NIUs reported testing significantly less frequently than was recommended (in both cases, p < 0.001), with wide variations within both groups. Many IUs (42%) and NIUs (50%) did not bring SMBG data regularly to medical visits, and 54% of IUs and 56% of NIUs did not respond regularly to out-of-range SMBG readings. HCPs were generally supportive and responsive to SMBG data. More frequent SMBG was associated with more regular HCP attention to SMBG records, for IUs (p = 0.02) and NIUs (p = 0.004).
CONCLUSIONS: Self-reported SMBG use is common in T2DM, though frequency is lower than HCP recommendations. Wide variations in actual and recommended SMBG were observed. HCP support for SMBG is reportedly common, and is associated with greater SMBG frequency. While SMBG data can be valuable, recommendations are often not followed and data often goes unused by both HCPs and patients.
AUTHORS: Polonsky, WH., Fisher, L., Guzman, S., Sieber, WJ., Philis-Tsimikas, A., Edelman, SV.
DATE: September-October, 2010
OBJECTIVE: The purpose of this study was to investigate patients’ experiences when diagnosed with type 2 diabetes and diabetes-related distress and self-management years later. Method One hundred seventy-nine adults with type 2 diabetes, 1 to 5 years after diagnosis, completed a questionnaire assessing what they were told and what was recommended at diagnosis as well as current diet, physical activity, and diabetes distress.
RESULTS: Most patients (60%) expressed confidence in their health care provider (HCP) at diagnosis, but 30% reported that a clear action plan was not communicated. Current diabetes distress was significantly lower among those who reported being reassured at diagnosis that diabetes could be managed successfully and had developed a clearer action plan with their HCP. Patients’ current dietary behaviors were significantly better among those receiving a clearer action plan at diagnosis.
CONCLUSIONS: Patients’ retrospective reports of reassuring HCP messages when diagnosed, along with the presentation of a clear action plan, are associated with less diabetes distress and better self-management at 1 to 5 years after diagnosis. Practical implications Findings suggest a long-lasting impact on patients’ attitudes and behaviors when the diagnosis of type 2 diabetes is delivered clearly, a sense of hope is provided, and a specific care plan is put forward.
STUDY TITLE: The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with Type 2 Diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial [NCT00674986].
AUTHORS: Polonsky, W., Fisher, L., Schikman, C., Hinnen, D., Parkin, C., Jelsovsky, Z., Amstutz, L., Schweitzer, M., Wagner, R.
DATE: May 18, 2010
BACKGROUND: The value and utility of self-monitoring of blood glucose (SMBG) in non-insulin treated T2DM has yet to be clearly determined. Findings from studies in this population have been inconsistent, due mainly to design differences and limitations, including the prescribed frequency and timing of SMBG, role of the patient and physician in responding to SMBG results, inclusion criteria that may contribute to untoward floor effects, subject compliance, and cross-arm contamination. We have designed an SMBG intervention study that attempts to address these issues.
METHODS/DESIGN: The Structured Testing Program (STeP) study is a 12-month, cluster-randomised, multi-centre clinical trial to evaluate whether poorly controlled (HbA1c >or= 7.5%), non-insulin treated T2DM patients will benefit from a comprehensive, integrated physician/patient intervention using structured SMBG in US primary care practices. Thirty-four practices will be recruited and randomly assigned to an active control group (ACG) that receives enhanced usual care or to an enhanced usual care group plus structured SMBG (STG). A total of 504 patients will be enrolled; eligible patients at each site will be randomly selected using a defined protocol. Anticipated attrition of 20% will yield a sample size of at least 204 per arm, which will provide a 90% power to detect a difference of at least 0.5% in change from baseline in HbA1c values, assuming a common standard deviation of 1.5%. Differences in timing and degree of treatment intensification, cost effectiveness, and changes in patient self-management behaviours, mood, and quality of life (QOL) over time will also be assessed. Analysis of change in HbA1c and other dependent variables over time will be performed using both intent-to-treat and per protocol analyses. Trial results will be available in 2010.
DISCUSSION: The intervention and trial design builds upon previous research by emphasizing appropriate and collaborative use of SMBG by both patients and physicians. Utilization of per protocol and intent-to-treat analyses facilitates a comprehensive assessment of the intervention. Use of practice site cluster-randomisation reduces the potential for intervention contamination, and inclusion criteria (HbA1c >or= 7.5%) reduces the possibility of floor effects. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviours.
TRIAL REGISTRATION: Current Controlled Trials NCT00674986.
AUTHORS: Polonsky, WH., Fisher, L., Hessler, D.
DATE: May, 2010
AIMS: To examine issues of weight misperception, perceived importance of weight management, and patient reports of their HCP’s weight-related recommendations among patients with type 2 diabetes.
METHODS: 575 overweight adults with type 2 diabetes completed a survey that assessed perceptions about weight management and discussions with HCP’s about weight issues.
RESULTS: Among patients with BMI>30, weight misperception was rare (<10%) and perceived importance of weight loss common (>85%). Among overweight patients with BMI<30, weight misperception was more common (47%) and importance of weight loss was endorsed less frequently (68%). Most patients reported that HCP’s had advised weight loss (72%) and discussed weight issues at most visits (59%). However, recommendations from HCP’s were rarely specific. Few were informed by HCP’s that certain diabetes medications might make weight management difficult. Weight misperception was less common, importance of weight loss was more common and weight management efforts were more frequent when HCPs discussed these issues directly.
CONCLUSIONS: Most overweight patients with type 2 diabetes recognize the importance of weight management. Patient reports indicate that HCP’s are actively engaged in promoting weight loss and that their recommendations, when specific, are associated with patients’ more frequent weight management efforts.
AUTHORS: Fisher, L., Glasgow, RE., Mullan, JT., Skaff, MM., Polonsky, WH.
DATE: May-June, 2008