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.

Disclosure

D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. S.Silbermann: Employee; Roche Diabetes Care. J.Kober: Employee; mySugr. K.Finke-groene: None. T.Roos: None. I.Vesper: None. V.L.Schaefer: Employee; Roche Diabetes Care. B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care.

Funding

Roche Diabetes Care GmbH (DC000097)

© 2023 by the American Diabetes Association
2023
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