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

September 20, 2026 updated by: Wang Weiqing, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is a prospective, multicenter, randomized, double-blind, parallel-controlled clinical trial conducted in about 40 MMC (Metabolic Management Center) hospitals across China, enrolling 1200 adult patients aged ≥18 years with type 2 diabetes mellitus, baseline HbA1c 7.0%-9.0%, combined with mild-to-moderate diabetic nephropathy (UACR 3.39-33.9 mg/mmol) or non-proliferative diabetic retinopathy. Subjects will be assigned 1:1 via central stratified randomization to the Chrocare AI clinical decision support system intervention group or routine physician care control group. The double-blind design separates physicians into two independent roles: one clinician interacts with patients and performs follow-up, another clinician generates treatment plans without direct patient contact, masking group allocation throughout the trial period. The Chrocare large language model automatically extracts multi-dimensional clinical data from hospital EHR, LIS and imaging systems, and generates individualized hypoglycemic, hypotensive and lipid-lowering regimens complying with domestic and international diabetes guidelines, alongside risk assessment of diabetic microvascular complications. The control group's treatment plans are developed by a panel of attending endocrinologists with more than 5 years of clinical experience through double independent review. All participants will undergo fixed visits at baseline, month 3 and month 6. Collected indicators include glycated hemoglobin, fasting and postprandial blood glucose, blood pressure, BMI, visceral fat, blood lipid profile, liver and renal function, urine albumin-creatinine ratio, and retinal grading. All hypoglycemia, cardiovascular events, hospitalizations and other adverse events will be fully documented for safety evaluation. The primary efficacy endpoint is the proportion of participants achieving HbA1c less than 7.0% at month 6. Secondary endpoints include changes in metabolic indicators, improvement of microvascular complications, guideline adherence rate of treatment plans, and incidence of inappropriate medication. Safety endpoints cover all adverse events and serious adverse events during the 6-month follow-up. Statistical analyses will be performed on the full analysis set, per-protocol set and safety set using SAS, SPSS and R software, with mixed-effect logistic regression and generalized estimating equations applied for between-group comparisons. This study is initiated and sponsored by the Principal Investigator from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and has obtained ethical approval from the institutional ethics committee prior to participant enrollment.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chrocare-Intervention Group

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

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.
Active Comparator: Routine-Control Group

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving HbA1c less than 7.0% at Month 6
Time Frame: 6 months after participant enrollment

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline to Month 3 and Month 6
Time Frame: 3 months and 6 months after participant enrollment

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.
3 months and 6 months after participant enrollment
Change in urine albumin-creatinine ratio (UACR) from baseline to Month 6
Time Frame: 6 months after participant enrollment

Variation of UACR after 6-month intervention, reflecting the improvement status of early diabetic nephropathy in participants.
6 months after participant enrollment
Change in diabetic retinopathy from baseline to Month 6
Time Frame: 6 months after participant enrollment

Variation of diabetic retinopathy after 6-month intervention, reflecting the improvement status of early diabetic retinopathy in participants.
6 months after participant enrollment
Proportion of treatment plans complying with domestic and international diabetes guidelines
Time Frame: Throughout the 6-month intervention period

The percentage of individualized hypoglycemic, hypotensive and lipid-lowering regimens consistent with clinical practice guidelines for type 2 diabetes, compared between two groups.
Throughout the 6-month intervention period
Incidence of hypoglycemia and all adverse events during follow-up
Time Frame: From baseline visit to Month 6 follow-up visit

Count and compare the occurrence rate of hypoglycemia, cardiovascular events and other adverse events in two groups within 6 months for safety evaluation.
From baseline visit to Month 6 follow-up visit
Accuracy of preliminary diagnosis of diabetic microvascular complications (diabetic retinopathy, diabetic nephropathy) at baseline assessment
Time Frame: Baseline visit (at participant enrollment)

Compare the preliminary diagnostic accuracy rate of diabetic complications including retinopathy and nephropathy between the AI intervention group and routine physician control group when conducting baseline evaluation for enrolled participants.
Baseline visit (at participant enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Weiqing Wang, Ruijin Hospital: Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 8, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 20, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 20, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-2026-392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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