Turnin Marie-Christine, Schirr-Bonnans Solène, Martini Jacques, Buisson Jean-Christophe, Taoui Soumia, Chauchard Marie-Christine, Costa Nadège, Lepage Benoît, Molinier Laurent, Hanaire Hélène
Department of Diabetology, Metabolic and Nutrition Diseases, University Hospital of Toulouse, 1 Avenue Jean Poulhès, TSA 50032, 31059 Toulouse Cedex 9, France.
DIAMIP Network, Toulouse, France.
Diabetol Metab Syndr. 2017 Jul 11;9:52. doi: 10.1186/s13098-017-0252-y. eCollection 2017.
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.
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 For patients in the intervention group, the device will be given to them for 1 year and then withdrawn during the second year of follow-up.
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.
2型糖尿病在全球的患病率相当高。为避免或延缓其慢性并发症,2型糖尿病患者应通过调整生活方式来改善血糖管理。这涉及改变糖尿病的控制方式。我们认为,得益于互联健康监测设备的技术创新,使用治疗性教育工具对2型糖尿病患者进行远程监测可能有助于他们调整治疗和生活方式习惯,从而改善血糖管理。
这是一项多中心、随机、对照、前瞻性研究。主要目的是在1年随访期后,比较远程监测与标准监测在糖化血红蛋白水平(HbA1c)变化方面的疗效。次要目的包括临床方面(知识、身体活动、体重等的变化)以及医学经济学方面。需要282名患者(每组141名患者)才能满足主要目的。对于干预组的患者,该设备将提供给他们使用1年,然后在随访的第二年撤掉。
本研究预期的益处是,通过改善2型糖尿病患者的生活方式,同时合理安排就诊,以降低并发症的发生率和长期成本,从而改善血糖管理。如果本研究结果表明,通过远程监测管理2型糖尿病在临床和经济方面均有效,那么该设备就可以提供给更多的糖尿病患者群体使用。