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: 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