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(R)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 HbA(1c)levels after a 12-month follow-up. Results:Six hundred sixty-five 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 HbA(1c)versus standard care after a 12-month 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, HbA(1c)changes and incidence of hypoglycemia were comparable between arms. Conclusions:A clinical and statistically significant reduction in HbA(1c)levels was found in those patients who used DIABEO at least once a day.