Application of FreeStyle Libre 2 for Evaluating Glycemic Variability Characteristics in Patients With Extreme Glucose Metabolism Phenotypes

This cross-sectional study aims to further subdivide diabetes mellitus into more homogeneous subgroups by focusing on extreme glucose metabolism phenotypes, including monogenic diabetes with β cell dysfunction, hyperinsulinemia caused by excessive β cell secretion, and postprandial hypoglycemia phenotypes. By utilizing continuous glucose monitoring (CGM) technology and the FreeStyle Libre 2 glucose monitoring device, this study will evaluate glycemic variability patterns in patients with extreme glucose metabolism phenotypes and perform comparative analyses using existing CGM data from healthy populations and patients with type 2 diabetes in our center's database. The study aims to address current gaps in understanding glycemic variability characteristics under extreme β cell functional states, provide novel dynamic monitoring evidence to support early identification, precise classification, and personalized management of these special metabolic states, and simultaneously screen for biomarkers to enable more accurate disease identification, thereby offering potential avenues for improving personalized treatment of diabetes mellitus.

NCT Number	NCT07564518
Lead Sponsor	Peking University People's Hospital
Conditions	Monogenic Diabetes, Hyperinsulinemia
Enrollment	120 participants
Start Date	2026-05-25
Primary Completion	2026-12-25 (estimated)
Study Completion	2027-01-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-02