Objective
The objective of this proposal is to test whether the addition of a psychological intervention that directly targets diabetes distress and diabetes self-management in young adults with type 1 diabetes will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone, which has become the current standard of type 1 diabetes care.
Background Rationale
Young adults (YA) with type 1 diabetes (T1D) have high levels of diabetes-related distress and some of the highest HbA1c levels among all age groups with T1D. Nevertheless, few if any studies have specifically targeted diabetes distress in YA with T1D. It remains unknown whether distress interventions can positively impact glycemic outcomes in YA with T1D, limiting availability of effective care for this vulnerable population. The YA period is unique, with psychological issues emerging most often during this developmental stage. In addition, increasing independence in diabetes self-management tasks and transitioning from pediatric to adult healthcare add significant burden for YA with T1D. Thus, a successful intervention approach to address diabetes distress in YA with T1D should be adapted to the unique stressors they face and be aligned with their developmental stage and preferences. Thirty-five years of behavioral science research has established that emotional distress is common in diabetes, is associated with problematic diabetes self-management, and predicts negative health outcomes. Various interventions for diabetes distress in adults T1D or type 2 diabetes have been developed and generally show positive effects on diabetes distress, while effects on glycemic control have been mixed. This evidence has supported treatment recommendations for routine assessment of diabetes distress as part of routine comprehensive diabetes care. However, several gaps remain to make diabetes distress interventions ready for clinical care dissemination: (1) available interventions are rarely sufficiently integrative in their approach to the closely related problems of diabetes distress and suboptimal glycemic control; (2) nearly all of the studies of associations between diabetes distress and glycemic control use designs that are inadequate for capturing the dynamic and potentially bi-directional influences between distress and glycemia, limiting our understanding of the causal nature of the relationship; (3) previously tested intervention approaches use treatments that cannot be sustained in clinical practice settings, limiting uptake in routine diabetes care where practical and billable approaches are urgently needed; and (4) as highlighted by the COVID-19 pandemic, there is an unmet need for interventions using remote technology to reach YA with T1D in their natural environments.
Description of Project
Young adults with type 1 diabetes have high levels of diabetes-related distress and some of the highest HbA1c levels among all age groups with type 1 diabetes. This project proposes to use telemedicine-delivered cognitive behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in young adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to CGM only in a randomized controlled clinical trial. Our central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. We propose to recruit 150 young adults (age 18-30) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, we plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.
Anticipated Outcome
• Potential new care approach to impact psychosocial and glycemic outcomes in young adults with type 1 diabetes
• Answer gap in literature of whether targeting diabetes distress with a specific psychological intervention improves glycemic outcomes in type 1 diabetes
• Testing of new research methodology pairing mobile ecological momentary assessment and continuous glucose monitoring (CGM) to perform intensive longitudinal analysis that provides data on within-person, day-to-day changes in diabetes distress, affective mood states, and diabetes self-management, and glycemia
• Calculation of intervention cost and implementation data for future dissemination plans
Relevance to T1D
This proposal will have major impact across several areas relevant to type 1 diabetes (T1D). We will directly test whether targeting diabetes distress and glycemic control in young adults with T1D with a time-limited cognitive behavioral intervention can result in clinically significant improvements, over those achieved with standard of medical care CGM alone. Our design is scientifically rigorous and our results will have a significant impact on our scientific understanding of the relationship between diabetes distress and glycemic levels and variability. Our approach is also translation-focused and aimed at addressing questions of interest to patients and providers. We lay the groundwork for a new therapeutic option for mental health and diabetes providers that can be disseminated widely through various clinical practice settings as a billable service, creating a sustainable model supporting implementation of recent guidelines that recommend routine screening and interventions for diabetes distress as part of comprehensive diabetes care. Our work will highlight new technologies and analytic approaches to uncover important relationships between emotional states and glycemic control in T1D, which other researchers can use in future diabetes technology, pharmacological, and behavioral trials. We also offer the larger T1D community with the potential for a new clinical approach to improve quality of life and glycemic control in T1D that is scalable, accessible, and sustainable.