A Multicenter Randomized Double-Blind Trial of Chrocare CDSS for Integrated Management of Type 2 Diabetes

This is a multicenter, randomized, double-blind, parallel-group clinical study for adults with type 2 diabetes and early diabetic kidney or retinal complications. A total of 1,200 eligible participants will be randomly divided into two groups at a 1:1 ratio. Participants in the intervention group will receive clinical management suggestions generated by the Chrocare large language model clinical decision support system, while those in the control group will receive standard diabetes care formulated by experienced endocrinologists. All participants will complete 3 study visits over 6 months to test blood glucose, glycated hemoglobin, blood lipids, kidney and eye indicators, and record hypoglycemia or other adverse events. The main goal of this research is to compare whether the AI-assisted management can help more patients reach target blood glucose levels, as well as evaluate the safety of this AI system for long-term diabetes integrated treatment.

Inclusion Criteria: * Aged ≥ 18 years old; * Clinically diagnosed with Type 2 Diabetes Mellitus; * Baseline glycated hemoglobin (HbA1c) ranges from 7.0% to 9.0%; * Complicated with mild-to-moderate diabetic nephropathy (UACR 3.39-33.9 mg/mmol) or mild non-proliferative diabetic retinopathy; * Voluntarily sign written informed consent form; * Able to complete all scheduled 6-month follow-up visits. Exclusion Criteria: * Type 1 diabetes, monogenic diabetes or secondary diabetes; * Severe cardiac, hepatic or renal dysfunction; proliferative diabetic retinopathy; * History of diabetic acute complications within 3 months before screening; active infectious diseases; * Pregnant, breastfeeding or planning pregnancy during the trial period; * Participated in other interventional clinical trials within the past 3 months; * Investigators judge the subject unsuitable for enrollment for any other reason.