Self-management of type 2 diabetes mellitus utilizing technology based mobile medical assisted blood glucose management: Study protocol for a prospective, multi-center, observational study

Abstract

IntroductionDiabetes mellitus is a major health concern globally as well as in China. Currently, the blood glucose (BG) control and patient outcome of diabetes are less than optimal, due to the poor adherence to established evidence-based treatment guidelines and low utilization of preventive care services by both providers and patients. Evidence suggest the benefit of mobile technology-based applications in improving BG monitoring and management in type 2 diabetes mellitus (T2DM). This study is designed to evaluate the effectiveness, safety and timeliness of the mobile internet technology in improving outpatients blood glucose self-management of Chinese T2DM. Methodsand Analysis: This is a prospective, single-arm, multi-center, observational study involving 250 hospitals across China. Patients aged ≥18 and ≤ 80 years with a diagnosis of T2DM and poor glycemic control, who were willing to receive premixed insulin analogues and could use their own WeChat account independently, were included in the study. The primary outcome of the study is to assess the benefit of programme based on change in hemoglobin A1c (HbA1c) from baseline to 3 months. Secondary outcomes included proportion of patients achieving HbA1c<7% at 3 months, change in fasting and postprandial glucose levels from baseline, incidence of hypoglycemia, frequency of self-monitoring blood glucose (SMBG), the patient behavior of BG monitoring on platform and the association of BG control with health care professionals (HCP)-patient interaction. The mobile based technology intervention can improve the HbA1c and BG levels in the patients receiving premixed insulin analogues and that the adherence of SMBG was increased and the incidence of hypoglycemia was decreased. Additionally, early detection of treatment-related hypoglycemia or other complications will contribute to timely therapeutic adjustments and lifestyle modifications under HCP's recommendations through the seamless HCP-patients interaction based on the mobile application. Ethics and disseminationThe study protocol was approved by the ethics committees from each study site according to the International Conference on Harmonization guidelines for Good Clinical Practice and conformed to Declaration of Helsinki. The results of the analyses will be shared with all the participating hospitals and will be published in peer-reviewed journals. No personal information will be included in the findings. RegistrationThis study was registered at chictr.org.cn (ChiCTR 1900021191).