DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial
| العنوان: | DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial |
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| المؤلفون: | Bruno Guerci, Pierre-Yves Benhamou, Yves Reznik, Pierre Simon, Sophie Borot, Yacine Kherbachi, P. Serusclat, Nathalie Jeandidier, Pierre Fontaine, Sylvia Franc, Geneviève d’Orsay, Anne Farret, B. Catargi, Lucy Chaillous, Hélène Hanaire, Bruno Detournay, Guillaume Charpentier, Pauline Schaepelynck, Alfred Penfornis |
| المساهمون: | CHU Strasbourg, Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Sud Francilien, CH Evry-Corbeil, Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Centre Hospitalier Universitaire [Grenoble] (CHU), Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud ), CHU Toulouse [Toulouse], Hôpital Lapeyronie [Montpellier] (CHU), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université de Lorraine (UL), Service Endocrinologie - Diabétologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Endocrinology, Diabetology and Nutrition, Clinique Portes du Sud, Venissieux, SANOFI Recherche, Voluntis, CEMKA-EVAL, National Association of Telemedicine, Evry, France |
| المصدر: | JMIR Research Protocols JMIR Research Protocols, JMIR publications, 2018, 7 (4), ⟨10.2196/resprot.9154⟩ |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | medicine.medical_specialty, Telemedicine, Randomization, [SDV]Life Sciences [q-bio], Population, 030209 endocrinology & metabolism, law.invention, diabetes, diabetes mellitus, telemedicine, eHealth, mHealth, clinical protocols, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Diabetes mellitus, medicine, Protocol, 030212 general & internal medicine, education, ComputingMilieux_MISCELLANEOUS, Glycemic, Type 1 diabetes, education.field_of_study, business.industry, General Medicine, medicine.disease, 3. Good health, chemistry, Emergency medicine, Glycated hemoglobin, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| الوصف: | 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 diabetiques de type 1 et de type 2 sous schema insulinique basal bolus par la TELEmedecine; 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://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd) |
| تدمد: | 1929-0748 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1d7d8622173af4d91828d4c28ac9cf90 https://pubmed.ncbi.nlm.nih.gov/29674306 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....1d7d8622173af4d91828d4c28ac9cf90 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19290748 |
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