DIABEO System Combining a Mobile App Software With and Without Telemonitoring Versus Standard Care: A Randomized Controlled Trial in Diabetes Patients Poorly Controlled with a Basal-Bolus Insulin Regimen
Sylvia Franc, H. Hanaire, Pierre‐Yves Benhamou, Pauline Schaepelynck, Bogdan Catargi, Anne Farret, P. Fontaine, Bruno Guerci, Yves Reznik, N. Jeandidier, Alfred Penfornis, Sophie Borot, Lucy Chaillous, Pierre Sérusclat, Yacine Kherbachi, Geneviève d’Orsay, B. Detournay, Pierre Simon, G. Charpentier
Abstract
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 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.