213-OR: ADA Presidents' Select Abstract: EMBARK—A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress in Adults with Type 1 Diabetes

Abstract

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. Disclosure 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. Funding National Institutes of Health (5R01DK121241)