664-P: Efficacy of a Digital Diabetes Logbook for Reducing Treatment Burden—Results of a Randomized Controlled Trial

The digital diabetes logbook mySugr is designed to help people with diabetes manage their diabetes and to reduce burden of diabetes management. To test the efficacy of the app, a randomized controlled trial (RCT) was conducted. The RCT was designed as a multi-center, open-label, parallel study with a 3-month follow-up in Germany. Participants were randomized to either using the mySugr app or to the treatment-as-usual control group in a 2:1 ratio. Primary outcome was change in diabetes distress using the Problem Areas in Diabetes (PAID) questionnaire. Based on the power analysis, the recruitment goal was 396 participants, anticipating 15% drop-out it was planned to recruit 466 participants. Robust regression was used to analyze the data with follow-up scores as dependent variable, group as independent variable and controlled for respective baseline scores. Primary analysis was based on the intention-to-treat population with jump-to-reference approach for multiple imputation of missing data. A total of 424 people with diabetes were randomized, 282 to the intervention and 142 to the control group (12.5% type 1 diabetes, 68.2% type 2 diabetes, 18.9% gestational diabetes, age: 51.7±15.2 years, 50% female, diabetes duration: 9.5±10.8 years, A1c: 7.1±1.5%, PAID: 21.6±17.4); 397 completed the 3-month follow-up. Intention-to-treat analysis revealed a significant between-group difference in the primary outcome (p = 0.0182). PAID scores at follow-up in the mySugr group were significantly lower than in the control group (Δ -2.20, 95% CI: -4.02 to -0.38). This was corroborated by the per-protocol analysis (Δ -2.43, 95% CI: -4.49 to -0.37, p = 0.0211). Recruitment was successful and could be stopped earlier due to the very low drop-out rate (6.4%). Use of mySugr led to a significant improvement in diabetes distress after 3 months compared to the treatment-as-usual control group. Thus, the efficacy of mySugr regarding the reduction of diabetes distress could be demonstrated in the RCT.