Diabetes distress (DD) refers to the fears, worries and burdens associated with the diabetes experience. DD is common, distinct from depression, and associated with glycemic and disease management. EMBARK is a randomized, controlled clinical trial comparing three interventions to reduce DD among adults with type 1 diabetes (T1D). Following baseline assessment, participants were randomly assigned to either: (1) Streamline, an educator-led education and management program, (2) TunedIn, a psychologist-led program focused exclusively on reducing DD, or (3) FixIt, an integration of StreamLine and TunedIn. All interventions were group-based (8 to 12 members) and virtual, including initial workshop(s), 1:1 phone calls, and follow-up meetings over a 4-month period. Recruitment occurred through clinics and community organizations in the U.S. Inclusion criteria were: T1D diagnosis, elevated DD (≥ 2.0 T1-DDS score), age ≥ 21 years, HbA1c ≥ 7.5% (58 mmol/mol), and English speaking. Regression analyses recorded change in DD from baseline to immediate post-intervention. A total of 300 adults with T1D participated (M±SD 46±15 years of age, 79% female, HbA1c 8.3%±0.9 (67 mmol/mol), T1-DDS score 2.8±0.8). Large and clinically meaningful reductions in total DD score occurred for each of the three study arms at follow-up (p < .001). The greatest DD reductions occurred in the FixIt intervention (Δ .88±.80), followed by TunedIn (Δ .59±.70), and then Streamline (Δ .48±.71); with DD reductions significantly greater in FixIt compared to Streamline (p = .005). The same pattern of results was evident in comparisons for the DD sources of Powerlessness (p < .001), Management (p = .06), Hypoglycemia (p = .009), and Physician Distress (p = .01). These preliminary findings highlight the benefit of focusing directly on the emotional side of diabetes to reduce DD and indicate that DD reductions are greatest when education and emotional DD-targeted interventions are integrated.
D.M.Hessler: Consultant; Lilly. A.Ahmann: Advisory Panel; Medtronic. U.Masharani: Research Support; Clementia Pharmaceuticals. L.Fisher: Consultant; Abbott Diabetes, Eli Lilly and Company, Research Support; Ascensia Diabetes Care. L.A.Strycker: None. W.H.Polonsky: Consultant; Abbott Diabetes, Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Insulet Corporation, Intuity Medical, Inc., MannKind Corporation, Provention Bio, Inc., Sanofi-Aventis U.S., Vertex Pharmaceuticals Incorporated. S.Guzman: Consultant; Abbott Diabetes. G.Aleppo: Advisory Panel; Medscape, Consultant; Bayer Inc., Insulet Corporation, Research Support; Dexcom, Inc., Eli Lilly and Company, Emmes, Insulet Corporation, Fractyl Health, Inc., WellDoc, Speaker's Bureau; Dexcom, Inc. E.Stephens: None. S.Kim: None. N.B.Argento: Advisory Panel; Dexcom, Inc., Eli Lilly and Company, ConvaTec Inc., Diabeloop SA, Senseonics, Speaker's Bureau; Dexcom, Inc., Boehringer Ingelheim and Eli Lilly Alliance, Novo Nordisk, MannKind Corporation, Zealand Pharma A/S, Xeris Pharmaceuticals, Inc., Eli Lilly and Company.
National Institutes of Health (5R01DK121241)