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.

Anne Farret, Guillaume Charpentier, Bruno Detournay, Lucy Chaillous, Alfred Penfornis, Sylvia Franc, Pierre Simon, Geneviève D'Orsay, Yacine Kherbachi, Pierre Fontaine, Hélène Hanaire, Bogdan Catargi, Sophie Borot, Pierre Serusclat, Nathalie Jeandidier, Pierre-Yves Benhamou, Pauline Schaepelynck, Yves Reznik, Bruno Guerci

Journal: Diabetes technology & therapeutics 2021;22(12):904-911

PMID: 32407148

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Abstract

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). 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 levels after a 12-month follow-up. 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 versus standard care after a 12-month follow-up: mean difference -0.41% for arm 2-arm 1 ( = 0.001) and -0.51% for arm 3-arm 1 ( ≤ 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 changes and incidence of hypoglycemia were comparable between arms. A clinical and statistically significant reduction in HbA levels was found in those patients who used DIABEO at least once a day.

Address: Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, and Centre d'étude et de Recherche pour l'Intensification du Traitement du Diabète (CERITD), Evry, France.; Department of Diabetology, Metabolic Diseases and Nutrition, CHU Toulouse, University of Toulouse, Toulouse, France.; Department of Diabetology, Pôle DigiDune, University Hospital, Grenoble, France.; Department of Nutrition-Endocrinology-Metabolic Disorders, Marseille University Hospital, Sainte Marguerite Hospital, Marseille, France.; Department of Endocrinology and Diabetes, University Hospital, Bordeaux, France.; Department of Endocrinology, Diabetes and Nutrition, University Hospital, Montpellier, France.; Department of Diabetology, University Hospital, Lille, France.; Endocrinology-Diabetes Care Unit, University of Lorraine, Vandoeuvre Lès Nancy, France.; Department of Endocrinology, University of Caen Côte de Nacre Regional Hospital Center, Caen, France.; Department of Endocrinology, Diabetes and Nutrition, CHU of Strasbourg, Strasbourg, France.; Professor at the University Paris-Sud, University Paris-Sud, Orsay, France.; Centre Hospitalier Universitaire Jean Minjoz, Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition, Besançon, France.; CHU de Nantes-Hospital Laennec, Saint-Herblain, France.; Endocrinology, Diabetology and Nutrition, Clinique Portes du Sud, Venissieux, France.; Sanofi-Diabetes, Gentilly, France.; Voluntis, Suresnes, France.; CEMKA-EVAL, Bourg-la-Reine, France.; National Association of Telemedicine, Evry, France.

DOI: 10.1089/dia.2020.0021

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MeSH Terms: Adult, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Internet, Male, Middle Aged, Mobile Applications, Telemetry