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

Abstract

BackgroundSelf-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.ObjectiveHere, 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.MethodsTELESAGE 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.ResultsThe 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.ConclusionsThe 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 RegistrationClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd)

Digital health technology and mobile devices for the management of diabetes mellitus: state of the art

“…A three-arm RCT found a 0.91% (9.9 mmol/mol) greater HbA 1c reduction at 6 months in the Diabeo plus telemedicine arm compared with usual care (p < 0.001), with no difference in hypoglycaemia [8]. Diabeo is commercially available in Europe [7], and a larger-scale RCT evaluating Diabeo with telemedicine support is underway in France to confirm the prior results [11]. In contrast, DID has been evaluated in two multicentre RCTs [9,10], both of which did not demonstrate efficacy in HbA 1c reduction.…”

Smartphone-Based Technology in Diabetes Management

“…Furthermore, it provides a basal adjustment algorithm along with educational messages. The Diabeo system also provides a multipatient dashboard for healthcare professionals, allowing remote patient management [26,27].…”

“…Eventually, the Telesage study will also assess the potential of the Diabeo telemedicine service in terms of its utility and efficacy. The study is in progress and the official results are not yet published [27].…”

Effects of continuous care for patients with type 2 diabetes using mobile health application: A randomised controlled trial

“…8,9 In China, the number of available mobile phones has rapidly increased, leading to widespread use throughout the country. 10 The mobile phone has been increasingly used in disease management in China, as indicated by the effective management of type 2 diabetes in China. 4 When an application design facilitates greater interaction between patients and providers, clinical outcomes can be improved.…”

“…Studies have shown that management inputs based on networked information platforms can significantly improve the blood glucose monitoring, dietary compliance, and self‐management ability of patients with type 2 diabetes . In China, the number of available mobile phones has rapidly increased, leading to widespread use throughout the country . The mobile phone has been increasingly used in disease management in China, as indicated by the effective management of type 2 diabetes in China .…”