Educ@dom: comparative study of the telemonitoring of patients with type 2 diabetes versus standard monitoring—study protocol for a randomized controlled study

BACKGROUND: The global prevalence of type 2 diabetes is considerable. To avoid or delay its chronic complications, patients with type 2 diabetes should improve blood glucose management by adapting their life style. This involves changing the way in which diabetes is controlled. We believe that, thanks to technological innovations in connected health-monitoring devices, the telemonitoring of type 2 diabetes patients using therapeutic educational tools is likely to help them adapt their treatment and lifestyle habits, and therefore improve blood glucose management. METHODS: This is a multicenter, randomized, controlled, prospective study. The primary objective is to compare the efficacy of telemonitoring to standard monitoring in terms of changes in glycated hemoglobin levels (HbA1c) after a 1 year follow-up period. The secondary objectives are clinical (changes in knowledge, physical activity, weight, etc.) and medical-economic. 282 patients are required (141 patients in each group) to satisfy the primary objective. For patients in the intervention group, the device will be given to them for 1 year and then withdrawn during the second year of follow-up. CONCLUSIONS: The anticipated benefits of this research are an improvement in blood glucose management in patients with type 2 diabetes by improving their lifestyle whilst rationalizing recourse to consultations in order to reduce the incidence of complications and cost in the long term. If the results of this study show that management of type 2 diabetes by tele monitoring is clinically effective and economical, this device could then be made available to a larger diabetic patient cohort.