An interventional study of AI large language model-based clinical decision support system and Standard diabetes integrated management formulated by endocrinologists in Type 2 Diabetes (T2DM), Diabetic Nephropathies and Diabetic Retinopathy (DR), sponsored by Shanghai Jiao Tong University School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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Among 28 studies in Diabetes Mellitus, Type 2 by Shanghai Jiao Tong University School of Medicine — 3 open to participants now, 4 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Shanghai Jiao Tong University School of Medicine.
Among the 28 studies in Diabetes Mellitus, Type 2 by Shanghai Jiao Tong University School of Medicine, this one is the 3rd largest by planned enrollment of the 27 interventional ones that give a count, is one of 3 that started in 2026, is one of 13 with no phase, and was the 28th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →3 of the 28 studies in Diabetes Mellitus, Type 2 by Shanghai Jiao Tong University School of Medicine are open now, in 1 country. Recruiting first, the newest first:
Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18–75
Shanghai Jiao Tong University School of Medicine
Ages 18–65
By country, each count listing its studies:
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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28 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 2 · Phase 4 9
First in 2004; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,200 is above the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 160 across the 27 interventional studies, 3,000 across the 1 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
1 of the studies in Diabetes Mellitus, Type 2 by Shanghai Jiao Tong University School of Medicine that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07570810Shanghai Jiao Tong University School of MedicineEfficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM | 2026-11-30 |
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Among the 28 studies in Diabetes Mellitus, Type 2 by Shanghai Jiao Tong University School of Medicine, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 6 months after participant enrollment
Change in HbA1c from baseline to Month 3 and Month 6
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.
Time frame: 3 months and 6 months after participant enrollment
Change in urine albumin-creatinine ratio (UACR) from baseline to Month 6
Variation of UACR after 6-month intervention, reflecting the improvement status of early diabetic nephropathy in participants.
Time frame: 6 months after participant enrollment
Change in diabetic retinopathy from baseline to Month 6
Variation of diabetic retinopathy after 6-month intervention, reflecting the improvement status of early diabetic retinopathy in participants.
Time frame: 6 months after participant enrollment
Proportion of treatment plans complying with domestic and international diabetes guidelines
The percentage of individualized hypoglycemic, hypotensive and lipid-lowering regimens consistent with clinical practice guidelines for type 2 diabetes, compared between two groups.
Time frame: Throughout the 6-month intervention period
Incidence of hypoglycemia and all adverse events during follow-up
Count and compare the occurrence rate of hypoglycemia, cardiovascular events and other adverse events in two groups within 6 months for safety evaluation.
Time frame: From baseline visit to Month 6 follow-up visit
Accuracy of preliminary diagnosis of diabetic microvascular complications (diabetic retinopathy, diabetic nephropathy) at baseline assessment
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.
Time frame: Baseline visit (at participant enrollment)
Plan to share: No
Start is estimated for Oct 2026; primary completion for Dec 2027, 13 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 13 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine →