DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial
Nathalie Jeandidier, Lucy Chaillous, Sylvia Franc, Pierre-Yves Benhamou, Pauline Schaepelynck, Hélène Hanaire, Bogdan Catargi, Anne Farret, Pierre Fontaine, Bruno Guerci, Yves Reznik, Alfred Penfornis, Sophie Borot, Pierre Serusclat, Yacine Kherbachi, Geneviève D'Orsay, Bruno Detournay, Pierre Simon, Guillaume Charpentier, Nathalie Jeandidier, Lucy Chaillous, Sylvia Franc, Pierre-Yves Benhamou, Pauline Schaepelynck, Hélène Hanaire, Bogdan Catargi, Anne Farret, Pierre Fontaine, Bruno Guerci, Yves Reznik, Alfred Penfornis, Sophie Borot, Pierre Serusclat, Yacine Kherbachi, Geneviève D'Orsay, Bruno Detournay, Pierre Simon, Guillaume Charpentier
Abstract
Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians.
Objective: Here, we present the protocol for a new study (Suivi A Grande Echelle d'une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels.
Methods: TELESAGE is a multicenter, double-randomized, open-label, three parallel-arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist's task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels.
Results: The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion.
Conclusions: The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients.
Trial registration: ClinicalTrials.gov NCT02287532; https://ichgcp.net/clinical-trials-registry/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd).
Keywords: diabetes, diabetes mellitus, telemedicine, eHealth, mHealth, clinical protocols.
Conflict of interest statement
Conflicts of Interest: NJ received personal compensation for board participation and speaking fees from Eli Lilly, Novo Nordisk, Sanofi Aventis and Roche. LC received personal compensation for board participation and speaking fees from Eli Lilly, Lifescan, Novo Nordisk, Roche Diagnostics, Medtronic and Sanofi Aventis. SF has received personal compensation for board participation and speaking fees from Novo Nordisk, Roche Diagnostics, Lifescan, Sanofi, Eli Lilly and received Research support from MSD. She is medical director and vice president of CERITD, which has developed the DIABEO system in collaboration with Voluntis, and is the main investigator of the TELESAGE study, sponsored by Sanofi-Diabetes (Gentilly, France). PYB has received personal compensation for board participation and speaking fees from Abbott, Eli Lilly, Lifescan, Novo Nordisk, Roche Diagnostics, Medtronic, Sanofi Aventis and Becton, Dickinson and Company. P Schaepelynck has received speaking fees from Sanofi, Abbott, Lilly and participation at boards of Novo-Nordisk and Sanofi. P Serusclat has received personal compensation for board participation and speaking fees from Johnson and Johnson, Astra-Zeneca, Eli Lilly, Medtronic, MSD, Novartis, Novo Nordisk and Sanofi Aventis. HH has received personal compensation for board participation and speaking fees from Abbott, Dexcom, Eli Lilly, Lifescan, Novo Nordisk, Roche Diagnostics, Medtronic, Sanofi Aventis and Becton, Dickinson and Company. BC and AF have no conflicts of interest to declare concerning this study. PF has received personal compensation for board participation and speaking fees from Abbott, Becton, Dickinson and Company, Eli Lilly, MSD, Novartis, Novo Nordisk and Sanofi. BG participated as advisory panel/board member of Sanofi, Eli Lilly, NovoNordisk, Novartis, GSK, MSD, Boehringer Ingelheim, AstraZeneca, Abbott, Medtronic and Roche Diagnostics. He also participated as clinical investigator for Sanofi, Eli Lilly, NovoNordisk, GSK, BMS, AstraZeneca, Medtronic, Abbott, Roche Diagnostics, MSD, Novartis, Janssen and Boehringer Ingelheim, and received research support from Medtronic, Vitalaire, Sanofi, Eli Lilly and Novo Nordisk. YR has received personal compensation for board participation and speaking fees from Novo Nordisk, Sanofi, Eli Lilly, Medtronic, Takeda, Abbott and Roche. AP received personal compensation for board participation and speaking fees from Abbott, Ascencia, Astra-Zeneca, Eli Lilly, Medtronic, MSD, Novartis, Novo Nordisk and Sanofi Aventis. SB has received honoraria from Sanofi, NovoNordisk, Lilly, Roche and Medtronic. YK is employee of Sanofi. GO is Chief Medical Officer at Voluntis (Suresnes, France). BD is employed by Cemka-Eval, a consulting team specializing in health economics, epidemiology, and outcomes research. He also received personal compensation for board participation and speaking fees from MSD, Novo-Nordisk, Sanofi, Lilly and Pfizer. P Simon received personal compensation for board participation and speaking fees from Sanofi Aventis. GC is employed by CERITD and received personal compensation for board participation, research funding or speaking fees from Astra-Zeneca, Boehringer, Eli Lilly, Johnson & Johnson, MSD, Novo-Nordisk, Sanofi-Aventis and Voluntis. The TELESAGE study is sponsored by Sanofi (Gentilly, France).
©Nathalie Jeandidier, Lucy Chaillous, Sylvia Franc, Pierre-Yves Benhamou, Pauline Schaepelynck, Hélène Hanaire, Bogdan Catargi, Anne Farret, Pierre Fontaine, Bruno Guerci, Yves Reznik, Alfred Penfornis, Sophie Borot, Pierre Serusclat, Yacine Kherbachi, Geneviève D'Orsay, Bruno Detournay, Pierre Simon, Guillaume Charpentier. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.04.2018.
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Source: PubMed