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NCT07833228
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A Multicenter Randomized Double-Blind Trial of Chrocare CDSS for Integrated Management of Type 2 Diabetes

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter Clinical Trial to Evaluate the Effectiveness and Safety of a Chrocare Large Model-Based Clinical Decision Support System for Integrated Management of Patients With Type 2 Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2026-10-08

Completion Date

2027-12-30

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

OTHER

AI large language model-based clinical decision support system

This 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.

OTHER

Standard diabetes integrated management formulated by endocrinologists

Individualized 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.

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China