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JMIR Res Protoc. 2018 Apr 19;7(4):e66. doi: 10.2196/resprot.9154.

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial.

Author information

1
Department of Endocrinology, Diabetes and Nutrition, University Hospital of Strasbourg, Strasbourg, France.
2
Hospital Laennec, University Hospital of Nantes, Saint-Herblain, France.
3
Centre d'Étude et de Recherche pour l'Intensification du Traitement du Diabète, Evry, Department of Diabetes, Sud-Francilien Hospital, University Paris-Sud, Orsay, Corbeil-Essonnes, France.
4
Pôle DigiDune, Department of Diabetology, University Hospital, Grenoble, France.
5
Department of Nutrition-Endocrinology-Metabolic Disorders, Marseille University Hospital, Sainte Marguerite Hospital, Marseille, France.
6
Department of Diabetology, Metabolic Diseases and Nutrition, University Hospital of Toulouse, University of Toulouse, Toulouse, France.
7
Department of Endocrinology and Diabetes, University Hospital, Bordeaux, France.
8
Department of Endocrinology, Diabetes and Nutrition, University Hospital, Montpellier, France.
9
Department of Diabetology, University Hospital, Lille, France.
10
Endocrinology-Diabetes Care Unit, University of Lorraine, Vandoeuvre Lès Nancy, France.
11
Department of Endocrinology, University of Caen Côte de Nacre Regional Hospital Center, Caen, France.
12
Department of Endocrinology, Metabolism, Diabetology and Nutrition, University Hospital Jean Minjoz, Besançon, France.
13
Endocrinology, Diabetology and Nutrition, Clinique Portes du Sud, Venissieux, France.
14
Sanofi-Diabetes, Gentilly, France.
15
Voluntis, Suresnes, France.
16
CEMKA Contract Research Organization, Bourg-la-Reine, France.
17
National Association of Telemedicine, Evry, France.

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://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd).

KEYWORDS:

diabetes, diabetes mellitus, telemedicine, eHealth, mHealth, clinical protocols

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