Prevalence and Incidence of Hypoglycaemia Among Patients With Type 2 Diabetes in China—A Prospective Cohort Study

AIMS: To estimate the prevalence and incidence of hypoglycaemia and the variations in Chinese type 2 diabetes (T2D) patients. MATERIALS AND METHODS: A multi-centre, non-interventional study was conducted across 103 hospitals in 20 provinces in China between 18 March 2022 and 5 December 2023. The study adopted an integrated 12-week prospective cohort study design, enrolling 15 437 adults with T2D. Hypoglycaemic events were captured through a structured questionnaire and patient diary, including laboratory-confirmed, symptomatic, any, severe and nocturnal hypoglycaemia. Variations in hypoglycaemia burden were examined by socio-demographic factors, health status, treatment regimens, geographic region and hospital level. The endpoints were the prevalence of patients experiencing at least one hypoglycaemic event and the corresponding incidence during the study period. RESULTS: The 15 437 participants who completed the follow-up at Week 12 were included in this study. During this period, 9.0% [95% CI: 8.6, 9.5] of the participants experienced at least one hypoglycaemic event, corresponding to an incidence rate of 79.8 [76.9, 82.8] events per 100 person-years. Hypoglycaemia burden differed markedly according to treatment background. The 12-week prevalence of any hypoglycaemia was 5.5%, 9.7% and 12.2% among participants receiving neither insulin nor secretagogues, secretagogues without insulin and insulin, respectively, with corresponding incidence rates of 48.6, 105.0 and 104.3 events per 100 person-years. Similar treatment-related patterns were observed for laboratory-confirmed, symptomatic and nocturnal hypoglycaemia. Hypoglycaemia burden also varied substantially across age, diabetes duration, body mass index (BMI), HbA1c, geographic region and hospital level. Greater hypoglycaemia burden was generally observed among participants with longer diabetes duration and lower BMI. The prevalence of any hypoglycaemia was highest in the eastern region and tertiary hospitals, whereas its incidence rate was highest in western regions and primary hospitals. CONCLUSIONS: Although the prevalence and incidence of hypoglycaemia among Chinese T2D patients were lower than previous studies, hypoglycaemia still remains a significant clinical concern. These findings highlight the importance of individualized strategies for glycaemic management to minimize hypoglycaemia risk in routine diabetes care. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2100053847.