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EMBARK—A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress and Improving HbA1c in Adults with Type 1 Diabetes

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posted on 2024-05-29, 17:27 authored by Danielle M. Hessler, Lawrence Fisher, Susan Guzman, Lisa Strycker, William H. Polonsky, Andrew Ahmann, Grazia Aleppo, Nicholas B. Argento, Joseph Henske, Sarah Kim, Elizabeth Stephens, Katherine Greenberg, Umesh Masharani

Objective: To compare the effectiveness of three interventions to reduce diabetes distress (DD) and improve HbA1c among adults with type 1 diabetes (T1D).

Research design and methods: Individuals with T1D (n=276) with elevated DD (>2 on T1 Diabetes Distress Scale) and HbA1c (>7.5%) were recruited from multiple settings and randomly assigned to one of three virtual group-based programs: (1) Streamline, an educator-led education and diabetes self-management program; (2) TunedIn, a psychologist-led program focused exclusively on emotional-focused DD reduction; or (3) FixIt, an integration of Streamline and TunedIn. Assessments of the primary outcomes of DD and HbA1c occurred at baseline, and at 3, 6, and 12 months.

Results: All three programs demonstrated substantive and sustained reductions in DD (Cohen’s d= 0.58 to 1.14) and HbA1c (Δ -0.4 to -0.72) at 12-month follow-up. TunedIn and FixIt participants reported significantly greater DD reductions compared to Streamline participants (p=.007). Streamline and TunedIn participants achieved significantly greater HbA1c reductions than FixIt participants (p=.006).

Conclusions: DD can be successfully reduced among distressed individuals with T1D with elevated HbA1c using both the education/behavioral and emotion-focused approaches included in the study. While both approaches are associated with significant and clinically meaningful reductions in DD and HbA1C, TunedIn, the emotion-focused program, displayed the most consistent benefits across both DD and HbA1c. Group-based, fully virtual and time limited, these findings suggest the overall value of emotion focused strategies, like those utilized in TunedIn, for adults with type 1 diabetes.

Funding

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK; R01DK121241). The funder had no role in this work.

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