1895-P: An Open-Label Study to Evaluate the Effect of Using the Diabetes:M Bolus Calculator Application in People with Type 1 Diabetes Mellitus on MDI or CSII

Introduction and Objective: There is growing evidence supporting the use of bolus insulin dose calculator apps in T1DM. The study aims to demonstrate the clinical utility of the Diabetes:M bolus calculator application in improving glycemic control in T1DM. Methods: In this open-label, non-randomized, single-arm study, 28 participants with T1DM on MDI or CSII, using CGM, were followed for 2 weeks on their usual treatment, followed by 2 weeks using the Diabetes:M bolus calculator. The efficacy and safety of the calculator were assessed using the absolute difference in the mean change in TIR% between the first and second phase, using sensor raw data. Results: Glucose parameters remained stable between phases. While Mann-Whitney U tests showed statistical significance due to large sample sizes (all p<0.001), effect sizes were negligible (Rank-biserial correlation: 0.009-0.036), indicating no clinically meaningful differences:TIR: 67.7% vs 68.0% (Δ +0.3%, p<0.001, effect size: 0.009) and Mean Glucose: 8.4 vs 8.5 mmol/L (Δ +0.1 mmol/L, p<0.001, effect size: 0.036). Conclusion: This study shows that the Diabetes:M bolus calculator maintains glycemic control comparable to standard care, with significant but clinically negligible differences in glucose metrics. The technology shows non-inferiority in safety and efficacy while facilitating insulin dose calculations, supporting its broader application to improve quality of life in T1DM. Disclosure R. Dimova: Speaker's Bureau; Ended; Boehringer Ingelheim International GmbH, Novo Nordisk, AstraZeneca. Research Support; Current; Sirma company. Speaker's Bureau; Ended; Merck & Co., Inc. T.I. Tankova: Speaker's Bureau; Current; Lilly, Novo Nordisk, Boehringer Ingelheim International GmbH, AstraZeneca. Speaker's Bureau; Ended; Medtronic. Speaker's Bureau; Current; Merck KGaA. A. Hristov: None. Funding Sirma Medical Systems