Diana Naranjo

REDEEM: A Pragmatic Trial to Reduce Diabetes Distress

OBJECTIVE To compare three interventions to reduce diabetes distress (DD) and improve self-management among non–clinically depressed adults with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS In REDEEM, 392 adults with T2DM and DD were randomized to computer-assisted self-management (CASM), CASM plus DD-specific problem solving (CAPS), or a computer-administered minimal supportive intervention. Primary outcomes were Diabetes Distress Scale (DDS) total, the Emotional Burden (EB) and Regimen Distress (RD) DDS subscales, and diet, exercise, and medication adherence. RESULTS Significant and clinically meaningful reductions in DD (DDS, EB, and RD) and self-management behaviors occurred in all three conditions (P < 0.001), with no significant between-group differences. There was, however, a significant group × baseline distress interaction (P < 0.02), in which patients with high baseline RD in the CAPS condition displayed significantly larger RD reductions than those in the other two conditions. RD generated the most distress and displayed the greatest distress reduction as a result of intervention. The pace of DD reduction varied by patient age: older patients demonstrated significant reductions in DD early in the intervention, whereas younger adults displayed similar reductions later. Reductions in DD were accompanied by significant improvements in healthy eating, physical activity, and medication adherence, although not by change in HbA1c. CONCLUSIONS DD is malleable and highly responsive to intervention. Interventions that enhance self-management also reduce DD significantly, but DD-specific interventions may be necessary for patients with high initial levels of DD. Future research should identify the minimal, most cost-effective interventions to reduce DD and improve self-management.

International and Interdisciplinary Identification of Health Care Transition Outcomes

IMPORTANCE There is a lack of agreement on what constitutes successful outcomes for the process of health care transition (HCT) among adolescent and young adults with special health care needs. OBJECTIVE To present HCT outcomes identified by a Delphi process with an interdisciplinary group of participants. DESIGN, SETTING, AND PARTICIPANTS A Delphi method involving 3 stages was deployed to refine a list of HCT outcomes. This 18-month study (from January 5, 2013, of stage 1 to July 3, 2014, of stage 3) included an initial literature search, expert interviews, and then 2 waves of a web-based survey. On this survey, 93 participants from outpatient, community-based, and primary care clinics rated the importance of the top HCT outcomes identified by the Delphi process. Analyses were performed from July 5, 2014, to December 5, 2014. EXPOSURES Health care transition outcomes of adolescents and young adults with special health care needs. MAIN OUTCOMES AND MEASURES Importance ratings of identified HCT outcomes rated on a Likert scale from 1 (not important) to 9 (very important). RESULTS The 2 waves of surveys included 117 and 93 participants as the list of outcomes was refined. Transition outcomes were refined by the 3 waves of the Delphi process, with quality of life being the highest-rated outcome with broad agreement. The 10 final outcomes identified included individual outcomes (quality of life, understanding the characteristics of conditions and complications, knowledge of medication, self-management, adherence to medication, and understanding health insurance), health services outcomes (attending medical appointments, having a medical home, and avoidance of unnecessary hospitalization), and a social outcome (having a social network). Participants indicated that different outcomes were likely needed for individuals with cognitive disabilities. CONCLUSIONS AND RELEVANCE Quality of life is an important construct relevant to HCT. Future research should identify valid measures associated with each outcome and further explore the role that quality of life plays in the HCT process. Achieving consensus is a critical step toward the development of reliable and objective comparisons of HCT outcomes across clinical conditions and care delivery locations.

Patients With Type 2 Diabetes at Risk for Major Depressive Disorder Over Time

PURPOSE We wanted to identify risk factors associated with the development of major depressive disorder (MDD) among patients with type 2 diabetes over time. METHODS In a noninterventional study, 338 adult patients with type 2 diabetes and no MDD diagnosis at baseline were assessed 3 times during 18 months (9-month intervals) to ascertain predictors of MDD. We tested a model incorporating personal, behavioral, biologic, and psychosocial variables to identify predictors of MDD. Exploratory analyses tested whether current negative affect mediated the relationship between predictors and subsequent MDD. We also conducted a stratified analysis of moderate vs high negative affect to explore whether level of baseline negative affect mediated the relationship between specific predictors and MDD. RESULTS Prior MDD and negative affect predicted future development of MDD. In subpopulations stratified by moderate negative affect, negative life events, an elevated body mass index (BMI), prior MDD, and poor control of glycated hemoglobin (hemoglobin A1c) each predicted MDD. In subpopulations stratified by elevated negative affect, negative life events and poor control of hemoglobin A1c predicted MDD. Current negative affect partially mediated the relationship between prior MDD and subsequent MDD, as well as the relationship between negative life events and subsequent MDD. CONCLUSIONS Although negative affect at baseline was the primary predictor of subsequent MDD, when stratified by negative affect, negative life events, BMI, and poor control of hemoglobin A1c also predicted MDD. Thus, life stresses and patients’ disease-related concerns are important when understanding what predicts subsequent MDD. Addressing depressive symptoms and broader life context issues expands the scope of a potential intervention to reduce the risk of developing MDD in persons with type 2 diabetes.

AASAP: A PROGRAM TO INCREASE RECRUITMENT AND RETENTION IN CLINICAL TRIALS

OBJECTIVE To evaluate a theory based, subject-centered, staff/subject communication program, AASAP (anticipate, acknowledge, standardize, accept, plan), to increase recruitment and retention in RCTs. METHODS AASAP was evaluated with logistical regression by comparing rates of recruitment (at telephone screening, baseline assessment, initial intervention) and intervention retention (over 16 weeks) before (-AASAP) and after (+AASAP) it was introduced to a 3-arm RCT to reduce disease distress among highly distressed subjects with type 2 diabetes. RESULTS Included were 250 subjects in -AASAP and 338 in +AASAP. Significant improvement in recruitment occurred at each of the 3 recruitment stages: agreed at screening (OR=2.52; p<0.001), attended baseline assessment (OR=1.91; p<0.001), attended initial intervention (OR=1.46; p<0.03). Higher education and shorter diabetes duration predicted better recruitment in -AASAP (OR=2.23; p<0.001), but not in +AASAP. AASAP also improved intervention retention over 16 weeks (OR=3.46; p<0.05). CONCLUSION AASAP is a structured program of subject/staff communication that helps improve external validity by enhancing both subject recruitment and retention. PRACTICAL IMPLICATIONS AASAP can be taught to non-professional staff and can be adapted to a variety of health settings. It can also be used by clinicians to engage patients in programs of ongoing care.

Diabetes Device Use in Adults With Type 1 Diabetes: Barriers to Uptake and Potential Intervention Targets

OBJECTIVE Diabetes devices (insulin pumps, continuous glucose monitors [CGMs]) are associated with benefits for glycemic control, yet uptake of these devices continues to be low. Some barriers to device uptake may be modifiable through psychosocial intervention, but little is known about which barriers and which patients to target. RESEARCH DESIGN AND METHODS We surveyed 1,503 adult T1D Exchange participants (mean age 35.3 [SD 14.8] years, mean diagnosis duration 20.4 [SD 12.5] years) to investigate barriers to device uptake, understand profiles of device users versus nonusers, and explore differences by age and sex. Scales used were the Diabetes Distress Scale, Technology Use Attitudes (General and Diabetes-Specific), and Barriers to Device Use and Reasons for Discontinuing Devices. RESULTS Most commonly endorsed modifiable barriers were related to the hassle of wearing devices (47%) and disliking devices on one’s body (35%). CGM users (37%) were older than nonusers (mean 38.3 vs. 33.5 years), had diabetes for longer (22.9 vs. 18.8 years), had more positive technology attitudes (22.6–26.0 vs. 21.4–24.8), and reported fewer barriers to using diabetes technology than nonusers (3.3 vs. 4.3). The youngest age-group (18–25 years) had the lowest CGM (26% vs. 40–48%) and insulin pump (64% vs. 69–77%) uptake, highest diabetes distress (2.2 vs. 1.8–2.1), and highest HbA1c levels (8.3% [67 mmol/mol] vs. 7.2–7.4% [55–57 mmol/mol]). CONCLUSIONS Efforts to increase device use need to target physical barriers to wearing devices. Because young adults had the lowest device uptake rates, highest distress, and highest HbA1c compared with older age-groups, they should be the focus of future interventions to increase device use.

Health and psychosocial outcomes in U.S. adult patients with diabetes from diverse ethnicities.

Within the United States, diabetes is a serious public health concern and patients with diabetes are more likely to experience clinical depression, psychological distress, and depressive symptoms than those without. Negative psychosocial factors are associated with poorer diabetes management and glycemic control. Overall, both the rates of diabetes and related psychological distress are greater for persons of diverse ethnicities than for non-Latino whites, and have reached epidemic proportions in certain groups. The following article will provide an overview across ethnicities of the rates of diabetes, health outcomes, psychosocial outcomes, and unique cultural and linguistic challenges that contribute to disparities within US diabetes patients of diverse ethnicities. Using this information, our hope is that health care practitioners and researchers alike can better respond to the psychosocial needs of ethnically diverse patients.

Predictors of Self-Management in Pediatric Type 1 Diabetes: Individual, Family, Systemic, and Technologic Influences

Type 1 diabetes (T1D) is a complex chronic disease that has many facets for successful management. The burden of this management falls largely on the individual and their family members. Self-management has a major influence on T1D health outcomes, and with successful management, children and adolescents with T1D can lead long and healthy lives. We discuss how various individual, family, and systemic/technologic factors influence T1D self-management, providing research that supports interventions targeting each of these factors. With this information, health care practitioners and researchers can better understand the role of T1D self-management and bolster this important aspect of T1D care.

Expectations and Attitudes of Individuals With Type 1 Diabetes After Using a Hybrid Closed Loop System

Purpose The first hybrid closed loop (HCL) system, which automates insulin delivery but requires user inputs, was approved for treatment of type 1 diabetes (T1D) by the US Food and Drug Administration in September 2016. The purpose of this study was to explore the benefits, expectations, and attitudes of individuals with T1D following a clinical trial of an HCL system. Methods Thirty-two individuals with T1D (17 adults, 15 adolescents) participated in focus groups after 4 to 5 days of system use. Content analysis generated themes regarding perceived benefits, hassles, and limitations. Results Some participants felt misled by terms such as “closed loop” and “artificial pancreas,” which seemed to imply a more “hands-off” experience. Perceived benefits were improved glycemic control, anticipated reduction of long-term complications, better quality of life, and reduced mental burden of diabetes. Hassles and limitations included unexpected tasks for the user, difficulties wearing the system, concerns about controlling highs, and being reminded of diabetes. Conclusion Users are willing to accept some hassles and limitations if they also perceive health and quality-of-life benefits beyond current self-management. It is important for clinicians to provide a balanced view of positives and negatives to help manage expectations.

Diabetes Technology Uptake, Outcomes, Barriers, and the Intersection With Distress

Patients managing type 1 diabetes have access to new technologies to assist in management. This manuscript has two aims: 1) to briefly review the literature on diabetes technology use and how this relates to psychological factors and 2) to present an example of human factors research using our data to examine psychological factors associated with technology use. Device/technology uptake and use has increased over the years and at present day is a common clinical practice. There are mixed results in terms of health and psychosocial outcomes, with specific subgroups doing better than others with technology. Our data demonstrated that patients have moderately elevated diabetes distress across differing types of technology used, from low-tech to high-tech options, possibly meaning that technology does not add or take away distress. In addition, users on multiple daily injections compared to all other technology groups have less positive attitudes about technology. Finally, we discuss implications for clinical practice and future research.

Fear of Hypoglycemia in Children and Adolescents and Their Parents with Type 1 Diabetes.

Hypoglycemia is a frequent occurrence in children and adolescents with type 1 diabetes. A variety of efforts have been made to standardize the definition of hypoglycemia and to define one of its most significant psychosocial consequences—fear of hypoglycemia (FOH). In addition to documenting the experience of FOH in children and adolescents type 1 diabetes and their parents, studies have investigated the relations between FOH and glycemic control and diabetes technology use. This review provides a summary of the recent FOH literature as it applies to pediatric type 1 diabetes.