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

Diabetes Care. 2024 Aug 1;47(8):1370-1378. doi: 10.2337/dc23-2452.

Abstract

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 (a score >2 on the total Type 1 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 = 0.58-1.14) and HbA1c (range, -0.4 to -0.72) at 12-month follow-up. TunedIn and FixIt participants reported significantly greater DD reductions compared with Streamline participants (P = 0.007). Streamline and TunedIn participants achieved significantly greater HbA1c reductions than did FixIt participants (P = 0.006).

Conclusions: DD can be successfully reduced among individuals with T1D with elevated HbA1c using both the educational/behavioral and emotion-focused approaches included in the study. Although both approaches are associated with significant and clinically meaningful reductions in DD and HbA1c, TunedIn, the emotion-focused program, had the most consistent benefits across both DD and HbA1c. The study findings suggest the overall value of group-based, fully virtual, and time-limited emotion-focused strategies, like those used in TunedIn, for adults with T1D.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Diabetes Mellitus, Type 1* / blood
  • Diabetes Mellitus, Type 1* / psychology
  • Diabetes Mellitus, Type 1* / therapy
  • Female
  • Glycated Hemoglobin* / analysis
  • Glycated Hemoglobin* / metabolism
  • Humans
  • Male
  • Middle Aged
  • Self-Management / methods
  • Stress, Psychological / prevention & control
  • Stress, Psychological / therapy

Substances

  • Glycated Hemoglobin
  • hemoglobin A1c protein, human