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.
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;
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;
Parallel
AI large language model-based clinical decision support system
Other interventionThis artificial intelligence large language model system automatically extracts electronic medical, laboratory and imaging data of type 2 diabetes patients, generates individualized hypoglycemic, hypotensive and lipid-lowering treatment plans complying with domestic and international diabetes guidelines, and provides risk assessment of diabetic microvascular complications for integrated chronic disease management during 6-month standardized follow-up.
Standard diabetes integrated management formulated by endocrinologists
Other interventionIndividualized 2-type diabetes comprehensive management schemes formulated by attending endocrinologists through double independent review, with identical 6-month unified follow-up and test indicators as the AI intervention group.
Proportion of participants achieving HbA1c less than 7.0% at Month 6
The percentage of subjects whose HbA1c level is below 7.0% after 6 months of intervention, compared between the Chrocare AI clinical decision support system group and the routine physician care control group. This indicator reflects the overall blood glucose control effect of integrated diabetes management.
Change in HbA1c from baseline to Month 3 and Month 6
Absolute change of HbA1c value at Month 3 and Month 6 compared with baseline level, to evaluate the short-term and medium-term glucose-lowering effect of two management strategies.
Change in urine albumin-creatinine ratio (UACR) from baseline to Month 6
Variation of UACR after 6-month intervention, reflecting the improvement status of early diabetic nephropathy in participants.
Change in diabetic retinopathy from baseline to Month 6
Variation of diabetic retinopathy after 6-month intervention, reflecting the improvement status of early diabetic retinopathy in participants.
Proportion of treatment plans complying with domestic and international diabetes guidelines
The percentage of individualized hypoglycemic, hypotensive and lipid-lowering regimens consistent with clinical practice guidelines for type 2 diabetes, compared between two groups.
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