Prevention and Treatment Effect of "General-Specialty" Graded Precision Management on Type 2 Diabetes Hypoglycemia: a Randomized Controlled Study

Background With the rising prevalence of diabetes and the widespread adoption of intensive glucose-lowering therapies, the incidence of hypoglycemia has increased significantly. The hazards and management of hypoglycemia remain critical clinical challenges. Objective To investigate the effect of the "General-Specialty" graded precision management model on the physical and mental health of type 2 diabetes patients with hypoglycemia in the community. Methods A total of 120 T2DM patients with a history of hypoglycemia within 6 months, who attended Shanggang Community Health Service Center in Pudong New Area, Shanghai from January to July 2023, were enrolled. The patients were divided into a control group and an experimental group, with 60 cases in each group, using a random number table method. The control group received routine management, while the experimental group was subjected to the "General-Specialty" graded precision management model. Based on the severity of hypoglycemia and individual patient conditions, subjects in the experimental group were referred to general practice clinics, specialized diabetes clinics, or transferred to tertiary hospitals. Additionally, comprehensive interventions were implemented, including real-time data-driven precise management, psychological intervention, comprehensive health education, and the establishment of a family support system. After 6 months of intervention, the two groups were compared in terms of blood glucose control parameters [fasting plasma glucose (FPG), hemoglobin A1c(HbA1c), time in range (TIR), and blood glucose coefficient of variation (CV)], the number of hypoglycemic episodes (total, mild, moderate, and severe), scores on the Chinese Hypoglycemia Fear Survey-Worry Scale (CHFSⅡ-WS), and the total score and dimension scores of the Diabetes-Specific Quality of Life Scale (DSQL). To evaluate the impact of the "General-Specialty" graded precision management model on the blood glucose control and fear of type 2 diabetes patients with hypoglycemia, and then evaluate the significance of this management model on the management of type 2 diabetes patients with hypoglycemia in the community. Results During the intervention period, 1 patient in the experimental group was lost to follow-up due to residential relocation. The results of repeated measures ANOVA showed that there was no interaction between group and time on BMI and waist circumference (Finteraction =1.922, 1.134; Pinteraction =0.162, 0.320).Time exerted a significant main effect on BMI and waist circumference (Ftime=7.507, 4.097; Ptime=0.003, 0.021), whereas group had no significant main effect on these parameters (Fgroup=0.598, 0.138; Pgroup=0.441, 0.711). No interaction between group and time was observed for systolic blood pressure (SBP) or diastolic blood pressure (DBP) (Finteraction =0.868, 0.151; Pinteraction =0.419, 0.860), and neither time nor group had a significant main effect on SBP or DBP (Ftime=1.295, 1.267; Ptime=0.276, 0.284; Fgroup=1.750, 0.337; Pgroup=0.188, 0.562). Significant interactions between group and time were detected for FPG, HbA1c, and CV (Finteraction =36.662, 15.157, 10.767, Pinteraction