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

Study acronym: Chrocare-DM
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07833228
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)
Type 2 Diabetes (T2DM), Diabetic Nephropathies, Diabetic Retinopathy (DR)
Related terms Diabetes Mellitus, Type 2, Diabetic Nephropathies, Diabetic Retinopathy
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov