Type 2 Diabetes (T2DM)Chrocare-DMNCT07833228

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

A study testing AI large language model-based clinical decision support system and Standard diabetes integrated management formulated by endocrinologists in people with Type 2 Diabetes (T2DM) and Diabetic Nephropathies, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes (T2DM), Diabetic Nephropathies, Diabetic Retinopathy (DR)
What is being tested?: AI large language model-based clinical decision support system and Standard diabetes integrated management formulated by endocrinologists
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,200 participants
Where: 1 siteChina
Study dates: 8 Oct 2026to 30 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weiqing Wang contact

021-64370045-671803

wqingw@shsmu.edu.cn

Yifei Zhang contact

feifei-a@163.com

China1 site

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Weiqing Wang, MD, PhD, 021-64370045-671803, wqingw@shsmu.edu.cn

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Conditions: Type 2 Diabetes (T2DM), Diabetic Nephropathies, Diabetic Retinopathy (DR)
Being tested: AI large language model-based clinical decision support system, Standard diabetes integrated management formulated by endocrinologists
Medical subject headings: Diabetes Mellitus, Type 2, Diabetic Nephropathies, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AI large language model-based clinical decision support systemOther
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.
Standard diabetes integrated management formulated by endocrinologistsOther
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.

Study groups in NCT07833228
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Standard diabetes integrated management formulated by endocrinologists

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months after participant enrollment

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline visit (at participant enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202630 Dec 2027

First posted22 Sep 2026
Study start8 Oct 2026 (estimated)
Primary completion1 Dec 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 1,200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07833228
Sponsor's protocol ID: EC-2026-392
Acronym: Chrocare-DM
Status last verified: Sep 2026
First submitted: 6 Sep 2026
Last updated: 22 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ning G. Medical Education in Diabetes Management on the New Horizon: Insights From Metabolic Management Center. J Diabetes. 2025 Mar;17(3):e70075. doi: 10.1111/1753-0407.70075. No abstract available.
PubMed 40107961
Zhang Y, Shi J, Peng Y, Zhao Z, Zheng Q, Wang Z, Liu K, Jiao S, Qiu K, Zhou Z, Yan L, Zhao D, Jiang H, Dai Y, Su B, Gu P, Su H, Wan Q, Peng Y, Liu J, Hu L, Ke T, Chen L, Xu F, Dong Q, Terzopoulos D, Ning G, Xu X, Ding X, Wang W. Artificial intelligence-enabled screening for diabetic retinopathy: a real-world, multicenter and prospective study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e001596. doi: 10.1136/bmjdrc-2020-001596.
PubMed 33087340
Zhang Y, Wang W, Ning G. Metabolic Management Center: An innovation project for the management of metabolic diseases and complications in China. J Diabetes. 2019 Jan;11(1):11-13. doi: 10.1111/1753-0407.12847. Epub 2018 Oct 3. No abstract available.
PubMed 30284373
Hu C, Zhang Y, Zhang J, Huo Y, Wan Q, Li M, Qi H, Du R, Zhu Y, Qin Y, Hu R, Shi L, Su Q, Yu X, Yan L, Qin G, Tang X, Chen G, Xu M, Wang T, Zhao Z, Chen Y, Gao Z, Wang G, Shen F, Luo Z, Chen L, Li Q, Ye Z, Zhang Y, Liu C, Wang Y, Wu S, Yang T, Deng H, Chen L, Zhao J, Mu Y, Wang W, Xu Y, Bi Y, Lu J, Ning G; REACTION Study Group. Age at menarche, ideal cardiovascular health metrics, and risk of diabetes in adulthood: Findings from the REACTION study. J Diabetes. 2021 Jun;13(6):458-468. doi: 10.1111/1753-0407.13128. Epub 2020 Dec 29.
PubMed 33135296
Wang T, Lu J, Su Q, Chen Y, Bi Y, Mu Y, Chen L, Hu R, Tang X, Yu X, Li M, Xu M, Xu Y, Zhao Z, Yan L, Qin G, Wan Q, Chen G, Dai M, Zhang D, Gao Z, Wang G, Shen F, Luo Z, Qin Y, Chen L, Huo Y, Li Q, Ye Z, Zhang Y, Liu C, Wang Y, Wu S, Yang T, Deng H, Li D, Lai S, Bloomgarden ZT, Shi L, Ning G, Zhao J, Wang W; 4C Study Group. Ideal Cardiovascular Health Metrics and Major Cardiovascular Events in Patients With Prediabetes and Diabetes. JAMA Cardiol. 2019 Sep 1;4(9):874-883. doi: 10.1001/jamacardio.2019.2499.
PubMed 31365039
Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.
PubMed 23796131
Taheri S, Zaghloul H, Chagoury O, Elhadad S, Ahmed SH, El Khatib N, Amona RA, El Nahas K, Suleiman N, Alnaama A, Al-Hamaq A, Charlson M, Wells MT, Al-Abdulla S, Abou-Samra AB. Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):477-489. doi: 10.1016/S2213-8587(20)30117-0.
PubMed 32445735
Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
PubMed 29221645
Leslie WS, Ford I, Sattar N, Hollingsworth KG, Adamson A, Sniehotta FF, McCombie L, Brosnahan N, Ross H, Mathers JC, Peters C, Thom G, Barnes A, Kean S, McIlvenna Y, Rodrigues A, Rehackova L, Zhyzhneuskaya S, Taylor R, Lean ME. The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial. BMC Fam Pract. 2016 Feb 16;17:20. doi: 10.1186/s12875-016-0406-2.
PubMed 26879684
Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
PubMed 36151309
Martindale APL, Llewellyn CD, de Visser RO, Ng B, Ngai V, Kale AU, di Ruffano LF, Golub RM, Collins GS, Moher D, McCradden MD, Oakden-Rayner L, Rivera SC, Calvert M, Kelly CJ, Lee CS, Yau C, Chan AW, Keane PA, Beam AL, Denniston AK, Liu X. Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines. Nat Commun. 2024 Feb 22;15(1):1619. doi: 10.1038/s41467-024-45355-3.
PubMed 38388497
Cruz Rivera S, Liu X, Chan AW, Denniston AK, Calvert MJ; SPIRIT-AI and CONSORT-AI Working Group; SPIRIT-AI and CONSORT-AI Steering Group; SPIRIT-AI and CONSORT-AI Consensus Group. Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. Nat Med. 2020 Sep;26(9):1351-1363. doi: 10.1038/s41591-020-1037-7. Epub 2020 Sep 9.
PubMed 32908284
Show us the evidence for the value of medical AI. Nat Med. 2026 Apr;32(4):1163. doi: 10.1038/s41591-026-04389-4. No abstract available.
PubMed 42014883
Nie J, Haft C, Xia A, Wang X. AI-Powered Diabetes Precision Health: From Data to Action. NEJM AI. 2025 Sep;2(9):10.1056/AIp2500475. doi: 10.1056/AIp2500475. Epub 2025 Aug 28.
PubMed 40918692
Ahmad E, Lim S, Lamptey R, Webb DR, Davies MJ. Type 2 diabetes. Lancet. 2022 Nov 19;400(10365):1803-1820. doi: 10.1016/S0140-6736(22)01655-5. Epub 2022 Nov 1.
PubMed 36332637

Interested in taking part?

Weiqing Wang

021-64370045-671803

wqingw@shsmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07833228
Acronym / sponsor ID: Chrocare-DM / EC-2026-392
Conditions: Type 2 Diabetes (T2DM), Diabetic Nephropathies, Diabetic Retinopathy (DR)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 1,200 participants (estimated)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 8 Oct 2026 (estimated)
Primary completion: 1 Dec 2027 (estimated)
Study completion: 30 Dec 2027 (estimated)
First posted: 22 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Chrocare-Intervention Group	Experimental	Other: AI large language model-based clinical decision support systemParticipants 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.
Routine-Control Group	Active comparator	Other: Standard diabetes integrated management formulated by endocrinologistsParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AI large language model-based clinical decision support systemThis 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.	Other	Chrocare-Intervention Group
Standard diabetes integrated management formulated by endocrinologistsIndividualized 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.	Other	Routine-Control Group

Primary outcome

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 secondary outcomes

Change in HbA1c from baseline to Month 3 and Month 6
Time frame: 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
Change in diabetic retinopathy from baseline to Month 6
Time frame: 6 months after participant enrollment
Proportion of treatment plans complying with domestic and international diabetes guidelines
Time frame: 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
Accuracy of preliminary diagnosis of diabetic microvascular complications (diabetic retinopathy, diabetic nephropathy) at baseline assessment
Time frame: Baseline visit (at participant enrollment)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Background: PubMed 40107961Ning G. Medical Education in Diabetes Management on the New Horizon: Insights From Metabolic Management Center. J Diabetes. 2025 Mar;17(3):e70075. doi: 10.1111/1753-0407.70075. No abstract available.
Background: PubMed 33087340Zhang Y, Shi J, Peng Y, Zhao Z, Zheng Q, Wang Z, Liu K, Jiao S, Qiu K, Zhou Z, Yan L, Zhao D, Jiang H, Dai Y, Su B, Gu P, Su H, Wan Q, Peng Y, Liu J, Hu L, Ke T, Chen L, Xu F, Dong Q, Terzopoulos D, Ning G, Xu X, Ding X, Wang W. Artificial intelligence-enabled screening for diabetic retinopathy: a real-world, multicenter and prospective study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e001596. doi: 10.1136/bmjdrc-2020-001596.
Background: PubMed 30284373Zhang Y, Wang W, Ning G. Metabolic Management Center: An innovation project for the management of metabolic diseases and complications in China. J Diabetes. 2019 Jan;11(1):11-13. doi: 10.1111/1753-0407.12847. Epub 2018 Oct 3. No abstract available.
Background: PubMed 33135296Hu C, Zhang Y, Zhang J, Huo Y, Wan Q, Li M, Qi H, Du R, Zhu Y, Qin Y, Hu R, Shi L, Su Q, Yu X, Yan L, Qin G, Tang X, Chen G, Xu M, Wang T, Zhao Z, Chen Y, Gao Z, Wang G, Shen F, Luo Z, Chen L, Li Q, Ye Z, Zhang Y, Liu C, Wang Y, Wu S, Yang T, Deng H, Chen L, Zhao J, Mu Y, Wang W, Xu Y, Bi Y, Lu J, Ning G; REACTION Study Group. Age at menarche, ideal cardiovascular health metrics, and risk of diabetes in adulthood: Findings from the REACTION study. J Diabetes. 2021 Jun;13(6):458-468. doi: 10.1111/1753-0407.13128. Epub 2020 Dec 29.
Background: PubMed 31365039Wang T, Lu J, Su Q, Chen Y, Bi Y, Mu Y, Chen L, Hu R, Tang X, Yu X, Li M, Xu M, Xu Y, Zhao Z, Yan L, Qin G, Wan Q, Chen G, Dai M, Zhang D, Gao Z, Wang G, Shen F, Luo Z, Qin Y, Chen L, Huo Y, Li Q, Ye Z, Zhang Y, Liu C, Wang Y, Wu S, Yang T, Deng H, Li D, Lai S, Bloomgarden ZT, Shi L, Ning G, Zhao J, Wang W; 4C Study Group. Ideal Cardiovascular Health Metrics and Major Cardiovascular Events in Patients With Prediabetes and Diabetes. JAMA Cardiol. 2019 Sep 1;4(9):874-883. doi: 10.1001/jamacardio.2019.2499.
Background: PubMed 23796131Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.
Background: PubMed 32445735Taheri S, Zaghloul H, Chagoury O, Elhadad S, Ahmed SH, El Khatib N, Amona RA, El Nahas K, Suleiman N, Alnaama A, Al-Hamaq A, Charlson M, Wells MT, Al-Abdulla S, Abou-Samra AB. Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):477-489. doi: 10.1016/S2213-8587(20)30117-0.
Background: PubMed 29221645Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
Background: PubMed 26879684Leslie WS, Ford I, Sattar N, Hollingsworth KG, Adamson A, Sniehotta FF, McCombie L, Brosnahan N, Ross H, Mathers JC, Peters C, Thom G, Barnes A, Kean S, McIlvenna Y, Rodrigues A, Rehackova L, Zhyzhneuskaya S, Taylor R, Lean ME. The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial. BMC Fam Pract. 2016 Feb 16;17:20. doi: 10.1186/s12875-016-0406-2.
Background: PubMed 36151309Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
Background: PubMed 38388497Martindale APL, Llewellyn CD, de Visser RO, Ng B, Ngai V, Kale AU, di Ruffano LF, Golub RM, Collins GS, Moher D, McCradden MD, Oakden-Rayner L, Rivera SC, Calvert M, Kelly CJ, Lee CS, Yau C, Chan AW, Keane PA, Beam AL, Denniston AK, Liu X. Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines. Nat Commun. 2024 Feb 22;15(1):1619. doi: 10.1038/s41467-024-45355-3.
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Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Weiqing Wang contact

021-64370045-671803

wqingw@shsmu.edu.cn

Yifei Zhang contact

feifei-a@163.com

Weiqing Wang principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weiqing Wang (021-64370045-671803, wqingw@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving HbA1c less than 7.0% at Month 6 (time frame: 6 months after participant enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07833228, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.