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.

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

ABSTRACT

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.


STUDY TITLE: Investigating Hypoglycemic Confidence in Type 1 and Type 2 Diabetes

AUTHORS: Polonsky WH, Fisher L, Hessler D, Edelman SV.

DATE: February, 2017

ABSTRACT

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.


STUDY TITLE: Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial

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

ABSTRACT

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: Health and Psychosocial Outcomes of a Telephonic Couples Behavior Change Intervention in Patients With Poorly Controlled Type 2 Diabetes: A Randomized Clinical Trial

AUTHORS: Trief PM, Fisher L, Sandberg J, Cibula DA, Dimmock J, Hessler DM, Forken P, Weinstock RS..

DATE: December, 2016

ABSTRACT

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.


STUDY TITLE: Impact of the Omnipod Insulin Management System on Quality of Life: A Survey of Current Users.

AUTHORS: Polonsky, WH., Hessler, D.,  Layne, JE.,  Zisser, H.

DATE: September 27, 2016

ABSTRACT

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.


STUDY TITLE: Exploring the role of the patient–physician relationship on insulin adherence and clinical outcomes in type 2 diabetes: Insights from the MOSAIc study†

AUTHORS: Linetzky, B., Jiang, D., Funnell, MM., Curtis, BH., Polonsky, WH.

DATE: August 17, 2016

ABSTRACT

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.


STUDY TITLE: Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors

AUTHORS: Polonsky, WH., Henry, RR.

DATE: July 22, 2016

ABSTRACT

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.


STUDY TITLE: The Impact of Real-Time Continuous Glucose Monitoring in Patients 65 Years and Older

AUTHORS: Polonsky, WH., Peters, AL., Hessler, D.
Author information

DATE: June 28, 2016

ABSTRACT

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

ABSTRACT

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.


STUDY TITLE: Diabetes distress in adults with type 1 diabetes: Prevalence, incidence and change over time

AUTHORS: Fisher, L., Hessler, D., Polonsky, W., Strycker, L., Masharani, U., Peters, A.

DATE: April 4, 2016

ABSTRACT

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.


STUDY TITLE: Psychosocial Impact of the Bionic Pancreas During Summer Camp

AUTHORS: Weissberg-Benchell, J., Hessler, D., Polonsky, WH., Fisher, L.

DATE: March 17, 2016

ABSTRACT

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.


STUDY TITLE: Understanding the Areas and Correlates of Diabetes-Related Distress in Parents of Teens With Type 1 Diabetes

AUTHORS: Hessler, D., Fisher, L., Polonsky, W., Johnson, N.

DATE: February 10, 2016

ABSTRACT

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.


STUDY TITLE: Emotional Distress in the Partners of Type 1 Diabetes Adults: Worries About Hypoglycemia and Other Key Concerns

AUTHORS:   Polonsky, WH., Fisher, L., Hessler, D., Johnson, N.

DATE: February 9, 2016

ABSTRACT

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.


STUDY TITLE: Prevalence of depression in Type 1 diabetes and the problem of over-diagnosis

AUTHORS: Fisher, L., Hessler, DM., Polonsky, WH., Masharani, U., Peters, AL., Blumer, I., Strycher, LA.

DATE: January 5, 2016

ABSTRACT

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.


STUDY TITLE: Identifying the worries and concerns about hypoglycemia in adults with type 2 diabetes

AUTHORS:  Polonsky, WH., Fisher, L., Hessler, D., Edelman, SV.

DATE: Nov-Dec. 2015

ABSTRACT

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.


STUDY TITLE: Development of a New Measure for Assessing Insulin Delivery Device Satisfaction in Patients with Type 1 and Type 2 Diabetes.

AUTHORS:  Polonsky, WH., Fisher, L., Hessler, D., Edelman, SV.

DATE: November, 2015

ABSTRACT

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.


STUDY TITLE: When does personalized feedback make a difference? A narrative review of recent findings and their implications for promoting better diabetes self-care

AUTHORS:  Polonsky, WH., Fisher, L.

DATE: August, 2015

ABSTRACT

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.


STUDY TITLE: Development of a New Measure for Assessing Glucose Monitoring Device-Related Treatment Satisfaction and Quality of Life.

AUTHORS:  Polonsky, WH., Fisher, L., Hessler, D., Edelman, SV.

DATE: September, 2015

ABSTRACT

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.


STUDY TITLE: Understanding the sources of diabetes distress in adults with type 1 diabetes

AUTHORS: Fisher, L., Polonsky, WH., Hessler, DM., Masharani, U., Blumer, I., Peters, AL., Strycher, LA., Bowyer, V.

DATE: May-June,  2015

ABSTRACT

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.


STUDY TITLE: Causal and bidirectional linkages over time between depression and diabetes regimen distress in adults with type 2 diabetes

AUTHORS: Hessler, D., Fisher, L., Strycker, LA., Arean, PA., Bowyer, V.

DATE: May, 2015

ABSTRACT

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.


STUDY TITLE: The confusing tale of depression and distress in patients with diabetes: a call for greater clarity and precision

AUTHORS: Fisher, L. Gonzalez, JS. , Polonsky, WH.

DATE: July, 2014

ABSTRACT

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.


STUDY TITLE: What is so tough about self-monitoring of blood glucose? Perceived obstacles among patients with Type 2 diabetes

AUTHORS:  Polonsky, WH. Fisher, L., Hessler, D., Edelman, SV.

DATE: January, 2014

ABSTRACT

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).


STUDY TITLE: Changes in A1C levels are significantly associated with changes in levels of the cardiovascular risk biomarker hs-CRP: results from the SteP study

AUTHORS: Schnell, O., Amann-Zalan, I., Jelsovsky, Z., Moritz, A., Bermejo, JL., Parkin, CG., Schweitzer, MA., Fisher, L., Polonsky, WH.

DATE: July, 2013

ABSTRACT

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

ABSTRACT
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.


STUDY TITLE: The impact of structured blood glucose testing on attitudes toward self-management among poorly controlled, insulin-naïve patients with type 2 diabetes

AUTHORS: Fisher, L., Polonsky, WH., Parkin, CG., Jelsovsky, Z., Petersen, B., Wagner, RS.

DATE: May, 2012

ABSTRACT

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.


STUDY TITLE: When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale

AUTHORS: Fisher, L., Hessler, DM., Polonsky, WH., Mullan, J.

DATE: February, 2012

ABSTRACT

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.


STUDY TITLE: A survey of blood glucose monitoring in patients with type 2 diabetes: are recommendations from health care professionals being followed?

AUTHORS: Polonsky, WH., Fisher, L., Hessler, D., Edelman, SV.

DATE: November, 2011

ABSTRACT

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.


STUDY TITLE: Are patients’ initial experiences at the diagnosis of type 2 diabetes associated with attitudes and self-management over time?

AUTHORS: Polonsky, WH., Fisher, L., Guzman, S., Sieber, WJ., Philis-Tsimikas, A., Edelman, SV.

DATE: September-October, 2010

ABSTRACT

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

ABSTRACT

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.


STUDY TITLE: Patient perspectives on the role of weight management in type 2 diabetes.

AUTHORS: Polonsky, WH., Fisher, L., Hessler, D.

DATE: May, 2010

ABSTRACT

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.


STUDY TITLE: Development of a brief diabetes distress screening instrument.

AUTHORS: Fisher, L., Glasgow, RE., Mullan, JT., Skaff, MM., Polonsky, WH.

DATE: May-June, 2008

ABSTRACT

PURPOSE: Previous research has documented that diabetes distress, defined as patient concerns about disease management, support, emotional burden, and access to care, is an important condition distinct from depression. We wanted to develop a brief diabetes distress screen instrument for use in clinical settings.

METHODS:  We assessed 496 community-based patients with type 2 diabetes on the previously validated, 17-item Diabetes Distress Scale (DDS17) and 6 biobehavioral measures: glycated hemoglobin (HbA(1c)); non-high-density-lipoprotein (non-HDL) cholesterol; kilocalories, percentage of calories from fat, and number of fruit and vegetable servings consumed per day; and physical activity as measured by the International Physical Activity Questionnaire.

RESULTS:  An average item score of > or =3 (moderate distress) discriminated high- from low-distressed subgroups. The 4 DDS17 items with the highest correlations with the DDS17 total (r = .56-.61) were selected. Composites, comprised of 2, 3, and 4 of these items (DDS2, DDS3, DDS4), yielded higher correlations (r=.69-.71). The sensitivity and specificity of the composites were .95 and .85, .93 and .87, and .97 and .86, respectively. The DDS3 had a lower sensitivity and higher percentages of false-negative and false-positive results. All 3 composites significantly discriminated subgroups on HbA(1c), non-HDL cholesterol, and kilocalories consumed per day; none discriminated subgroups on fruit and vegetable servings consumed per day; and only the DDS3 yielded significant results on the International Physical Activity Questionnaire. Because of its psychometric properties and brevity, the DDS2 was selected as a screening instrument.

CONCLUSIONS:  The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS17 can be administered to those who have positive findings on the DDS2 to define the content of distress and to direct intervention.