932-P: Impact of a Titration App for Basal Insulin on Glycaemic Outcomes in People with Type 2 Diabetes on an Oral-Basal Insulin Regimen—Results of an RCT

Abstract

A multicenter RCT analyzed the efficacy of a basal insulin titration app (myDose Coach; MDC) in people with type 2 diabetes and newly initiated or existing basal insulin treatment. We randomized 251 participants in a 1:1 ratio to either the intervention arm (insulin titration with MDC) or the control arm (insulin titration without App). The primary outcome was A1c reduction after 3-month. Baseline data (median age 60.0 years IQR 56.0 - 66.5; HbA1c 8.2 IQR 7.7 - 9.1%) showed no significant differences. After a median follow-up of 91.0 days, the intervention group showed a reduction in HbA1c of 0.93, IQR 0.40 - 1.57 percentage points compared to the control group (0.6; IQR 0.10 -1.40); adjusted difference between groups 0.35; 95% CI 0.35 0.01 - 0.69; p=0.0064. Improvements in follow-up A1c were evident across the range of A1c values (Figure 1). The respective differences between groups in glucose level (19.3; 95% CI 9.10 - 29.97 mg/dl; p=0.0012), fasting glucose (10.5; 95% CI 1.5 - 19. 0 mg/dl) and % < 180 mg/dl (12.2; 95% CI 3.8 - 20.5; p=0.0065) all favored the intervention group, while % < 70 mg/dl (−0.2; 95% CI −1.0 - 0.6; p=0.8778) did not differ substantially. Titration of basal insulin with the MDC app significantly improved glycemic management, without increasing exposure to low glucose values substantially. Thus, titration with the MDC app has a medical benefit beyond usual care. Disclosure 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. D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. T.Roos: None. K.Finke-groene: None. 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 Sanofi