DIABEO System Combining a Mobile App Software with and without Telemonitoring versus Standard Care: A Randomized Controlled Trial in Diabetic Patients Poorly Controlled with a Basal-Bolus Insulin Regimen.

BACKGROUND: The DIABEO system (DS) is a telemedicine solution that combines a mobile app for patients with a web portal for health care providers. DS allows real-time monitoring of basal-bolus insulin therapy as well as therapeutic decision making integrating both basal and bolus dose calculation. Real-life studies have shown a very low rate of use of mobile health applications by patients. Therefore, we conducted a large randomized controlled trial study to investigate the efficacy of DS in conditions close to real-life (TELESAGE study). METHODS: TELESAGE was a multicenter, randomized, open study with three parallel arms: arm 1 (standard care), arm 2 (DIABEO® alone) and arm 3 (DIABEO® + telemonitoring by trained nurses). The primary outcome assessed the reduction in HbA1c levels after a 12-month follow-up. RESULTS: Six hundred sixty-five (665) patients were included in the study. Participants who used DIABEO® once or more times a day (DIABEO® users) showed a significant and meaningful reduction of HbA1c versus standard care after 12-months follow up: mean difference -0.41% for arm 2 - arm 1 (P=0.001) and -0.51% for arm 3 - arm 1 (P≤0.001). DIABEO® users included 25.1% of participants in arm 2 and 37.6% in arm 3. In the intention-to-treat population, HbA1c changes and incidence of hypoglycemia were comparable between arms. CONCLUSIONS: A clinical and statistically significant reduction in HbA1c levels was found in those patients who used DIABEO® at least once a day.