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

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 HbA_1c 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.