985-P: Is Insulin Titration Supported by a Titration App Safe? Safety Results of an RCT

Abstract

A multicenter RCT in people with type 2 diabetes has shown that the use of a basal insulin titration app (myDose Coach) reduced A1c levels by 0.35 percentage points compared to titration without an app. Is the use of such a titration app associated with safety issues? We used negative binomial regressions to analyze the occurrence of adverse and serious adverse events (AE, SAE) and exposure to dangerously low (<54 mg/dl) or high (>250 mg/dl) glucose levels in 251 participants (age 60.0 years IQR 56.0 - 66.5; HbA1c 8.2 IQR 7.7 - 9.1%) randomized equally to the control and intervention groups. A total of 30 AEs (16 vs. 14 events) occurred in the control and intervention groups, of which 14 were SAEs (7 vs. 7 events). No event was judged to be associated with study participation or the interventions. The rates of dangerous low and high glucose in the control and intervention group were 0.12% vs. 0.10% for %< 54 mg/dl and 4.9% vs. 3.6% for %< 250 mg/dl, respectively (see Figure 1 for IRR and p values for superiority). A post-hoc non-inferiority test for the occurrence of %< 54 mg/dl and >250 mg/dl with non-inferiority margins of < 1% and < 5%, respectively, showed significant non-inferiority regarding the intervention group (both p < 0.01) with a post-hoc power by 75% respectively 55%. The results did not indicate an increased risk for insulin titration by the evaluated app compared to the control condition in terms of AE or extreme glucose excursions. Disclosure B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care. 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. 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. Funding Sanofi