A Multicenter Randomized Double-Blind Trial of Chrocare CDSS for Integrated Management of Type 2 Diabetes (Chrocare-DM)
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Weiqing Wang
- 电话号码：021-64370045-671803
- 邮箱：wqingw@shsmu.edu.cn
研究联系人备份
- 姓名：Yifei Zhang
- 邮箱：feifei-a@163.com
学习地点
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Shanghai、中国
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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接触：
- Weiqing Wang, MD, PhD
- 电话号码：021-64370045-671803
- 邮箱：wqingw@shsmu.edu.cn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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. |
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. |
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有源比较器：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. |
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of participants achieving HbA1c less than 7.0% at Month 6
大体时间：6 months after participant enrollment
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in HbA1c from baseline to Month 3 and Month 6
大体时间：3 months and 6 months after participant enrollment
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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
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Change in urine albumin-creatinine ratio (UACR) from baseline to Month 6
大体时间：6 months after participant enrollment
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Variation of UACR after 6-month intervention, reflecting the improvement status of early diabetic nephropathy in participants. |
6 months after participant enrollment
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Change in diabetic retinopathy from baseline to Month 6
大体时间：6 months after participant enrollment
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Variation of diabetic retinopathy after 6-month intervention, reflecting the improvement status of early diabetic retinopathy in participants. |
6 months after participant enrollment
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Proportion of treatment plans complying with domestic and international diabetes guidelines
大体时间：Throughout the 6-month intervention period
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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
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Incidence of hypoglycemia and all adverse events during follow-up
大体时间：From baseline visit to Month 6 follow-up visit
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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
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Accuracy of preliminary diagnosis of diabetic microvascular complications (diabetic retinopathy, diabetic nephropathy) at baseline assessment
大体时间：Baseline visit (at participant enrollment)
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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)
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合作者和调查者
调查人员
- 首席研究员：Weiqing Wang、Ruijin Hospital: Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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