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

NCT07833228 | Not Yet Recruiting

• 1 other identifier: EC-2026-392
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes (T2DM); Diabetic Retinopathy (DR); Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after participant enrollment

Secondary Outcomes (6)

• Change in HbA1c from baseline to Month 3 and Month 6

  3 months and 6 months after participant enrollment

• Change in urine albumin-creatinine ratio (UACR) from baseline to Month 6

  6 months after participant enrollment

• Change in diabetic retinopathy from baseline to Month 6

  6 months after participant enrollment

• Proportion of treatment plans complying with domestic and international diabetes guidelines

  Throughout the 6-month intervention period

• Incidence of hypoglycemia and all adverse events during follow-up

  From baseline visit to Month 6 follow-up visit

Study Arms (2)

Chrocare-Intervention Group

EXPERIMENTAL

Participants receive integrated type 2 diabetes management recommendations generated by the Chrocare large language model clinical decision support system. The model automatically extracts multi-source clinical data, generates individualized hypoglycemic, hypotensive and lipid-lowering regimens consistent with diabetes guidelines, and assesses microvascular complication risks. All participants complete standardized follow-up visits at baseline, Month 3 and Month 6 with unified laboratory and imaging tests.

Other: AI large language model-based clinical decision support system

Routine-Control Group

ACTIVE COMPARATOR

Participants receive standard integrated type 2 diabetes care formulated by experienced attending endocrinologists through double independent review. Physicians develop individualized treatment plans based on identical clinical data sources used in the intervention group. All participants complete the same 3 standardized follow-up visits and unified laboratory/imaging examinations within 6 months.

Other: Standard diabetes integrated management formulated by endocrinologists

Interventions

AI large language model-based clinical decision support system OTHER

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.

Chrocare-Intervention Group

Standard diabetes integrated management formulated by endocrinologists OTHER

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.

Routine-Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Weiqing Wang

  Ruijin Hospital: Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiqing Wang

CONTACT

021-64370045-671803; wqingw@shsmu.edu.cn

Yifei Zhang

CONTACT

feifei-a@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 22, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)