Efficacy of a type 2 diabetes self-management model with family doctor team support in southern China: a randomised controlled trial

Abstract

BackgroundChina has the highest number of people with diabetes in the world, with a diabetes prevalence of 11·6% and prediabetes prevalence of 50·1%. In China, diabetes self-management support is poorly implemented, with low adherence to self-care recommendations. Effective strategies to assist patients in managing diabetes are therefore urgently needed. The purpose of this study was to investigate the efficacy of a novel self-management model plus family doctor team support for patients with type 2 diabetes. MethodsThis randomised controlled trial was done in Longfeng Street Community Health Service Center (LSCHSC) in Guangdong province, southern China. Patients with type 2 diabetes with no hepatic or renal dysfunction, mental illness, or language disorders were eligible. Patients were randomly selected (using computer-generated randomisation numbers) from the diabetic archives in LSCHSC, and assigned (1:1) to either the intervention or control group, also using a computer-generated randomisation list. Participants, investigators, and those assessing outcomes were not masked to group assignment. Each patient in the intervention group signed a contract with the family doctor team of LSCHSC. Standard operating procedures for follow-up management were developed for patients in the intervention group, and an individual medical record system was established to monitor lifestyle interventions. Additionally, patients' family doctor teams provided training on healthy lifestyle self-management for the patients and their family members (eg, lectures and consultations, in-person interviews, diabetic clubs, and diabetes outreach activities), which is ongoing. Patients in the control group were provided with regular health education. The primary endpoint was laboratory measures and fundus disorders at 18 months after initiation of the intervention, analysed in the per-protocol population. The study was approved by the ethics committee of LSCHSC, and informed consent was obtained from each participant. FindingsBetween March 1, 2015, and May 31, 2015, 600 adults with type 2 diabetes were enrolled (300 to the intervention group and 300 to the control group). Baseline demographic, clinical characteristics, and laboratory measures were similar between groups. After 18 months of follow-up, 263 participants in the intervention group and 278 in the control group remained in the study and were analysed. Concentrations of several laboratory measures were significantly lower in intervention group than the control group (triglyceride, p=0·0082; total cholesterol, p=0·001; low-density lipoprotein, p=0·002; urinary creatinine, p=0·001; fasting blood glucose, p<0·0001; and post-prandial blood glucose, p=0·008), whereas high-density lipoprotein concentrations were significantly higher in the intervention group (p=0·019). No significant differences in HbA1c (p=0·10), urinary albumin (p=0·30), and the ratio of urinary albumin to urinary creatinine (p=0·24) were noted between the two groups. The proportion of patients with diabetic retinopathy (stage R0) did not significantly differ between the two groups (37 [11%] of 346 eyes in the intervention group vs 50 [12%] of 432 eyes in the control group; p=0·75). InterpretationType 2 diabetes self-management with support from a family doctor team in a community health service centre might be an effective strategy to control disease progression and improve patients' quality of life. Benefits to ocular complication of diabetes need further investigation. FundingNational Nature Science Foundation of China (81570843) and National Natural Science Foundation of China for Young Scholar (81600707).