1052-OR: A Multicenter Randomized Controlled Trial of an App to Reduce Distress among Young Adults with Diabetes

Introduction and Objective: Mental health (MH) conditions are common among young people with diabetes, affecting self-management and increasing complications risk. The aim of this trial was to test the efficacy of an app to reduce distress among young adults with diabetes. Methods: This multicenter, open-label trial (ACTRN12623000734662) randomized young adults aged 16-30y with diabetes and a MH condition from 8 Australian hospitals to start a bespoke app providing both diabetes and MH self-management tools or continue with standard care. Presence of a MH condition was defined as any past history, the presence of a Kessler Psychological Distress Scale (K10) ≥40 and/or a Problem Areas in Diabetes (PAID) scale ≥ 20. The primary outcome was change in K10, and secondary outcomes included change in PAID or HbA1c, assessed at baseline and 6 months. Analyses were performed by both intention to treat (ITT) and per-protocol (PP) by a blinded statistician. Results: Of the 142 participants (mean age 22±4y), 50% female, 71.8% European, BMI 27.6±6.3 kg/m2, 95.1% Type 1 diabetes), 71 were randomised to the app, with 68% (48/71) successfully onboarding. Engagement was high (6-7 sessions and 3 tasks/day). The crude mean (SD) difference (Intervention vs control) in K10 was not significantly different by ITT: -4.74 (8.59) vs -3.48 (6.41), Treatment effect (95% CI) -1.23 (-4.25,1.8) or PP: -4.06 (9.06) vs -3.11 (5.96) respectively, Treatment effect-1.28 (-4.31,2.19). The crude mean (SD) difference in PAID was not significantly different in the ITT analysis -8.83 (16.99) vs -4.14 (16.57), Treatment effect -4.88 (-12.05,2.29) (ITT) but significantly lower in the PP analysis: -9.6 (16.65) vs -3.05 (16.62) respectively, Treatment effect: -7.67 (-15.05, -0.06, p=0.047). The HbA1c and weight differences trended downwards but were not significant. Conclusion: While only 2/3 of young adults with diabetes with MH onboarded the app, those who did engaged well with a reduction in PAID score. Larger trials are needed to test whether apps can improve the MH of young adults with diabetes. Disclosure D. Simmons: Speaker's Bureau; Ended; Novo Nordisk. Other - Educational grant; Ended; Abbott Diabetes. Research Support; Current; Novo Nordisk. Consultant; Ended; Dexcom, Inc. S. Abdo: None. J. Greenfield: Research Support; Current; Novo Nordisk A/S. M.E. Craig: None. M. Reyes: Speaker's Bureau; Current; Lilly. R. Hicks: None. W.K. Tannous: None. T. Wong: None. V.W. Wong: None. K.O. Mathews: None. M. Piya: Advisory Panel; Ended; Novo Nordisk. Speaker's Bureau; Current; Novo Nordisk. Advisory Panel; Ended; Eli Lilly and Company. Speaker's Bureau; Current; Eli Lilly and Company. Advisory Panel; Ended; Boehringer Ingelheim International GmbH. Speaker's Bureau; Ended; Johnson Ended; Abbott Diabetes. P. Hay: None. Funding MTPConnect (TTRA2004)