Type 2 DiabetesiNCDSS-3NCT04642378

Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients

A study testing iNCDSS based insulin regime and routine insulin treatment regime in people with Type 2 Diabetes, run by Shanghai Zhongshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multi-center, single-blind, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System (iNCDSS) in patients with Type 2 Diabetes Mellitus. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: iNCDSS based insulin regime and routine insulin treatment regime
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 1 siteChina
Study dates: 1 Oct 2021to 8 Sep 2022
Phase: Interventional
Are there results?: None posted in the registry

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

Men or women aged 18 and above years old;
Subjects who had been diagnosed with type 2 diabetes;
Subjects who are on diabetes treatment for at least 3 months;
HbA1c: 7.0%-11.0%.

Who cannot join

Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
Subjects who change the insulin regimens during hospitalization;
BMI ≥ 45kg/m2;
Women who are pregnant or nursing;
Subjects with severe cardiac, hepatic, renal or general diseases;
Subjects with psychiatric disorders or impaired cognitive function;

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Subjects with severe edema, infections or peripheral circulation disorders;
Patients treated with surgery during hospitalization;
Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

180 Fenglin Road
Shanghai, 200032

Other trials in China

About this study

Official title: Study to Assess the Efficacy and Safety of iNCDSS Assisted Insulin Dosage Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients : a Muticenter, Single-blind, Randomized Controlled Study

Read the detailed description

As one of the most common treatments for diabetes inpatients, insulin regimens often vary due to different physicians. Since 2016, Zhongshan Hospital has set up the Internet-based glucose management system (iGMS) to monitor plasma glucose of diabetes patients, and further set up an Artificial Intelligence Assisted Insulin Titration System (iNCDSS) to recommend insulin regime in 2019. Previous single-center clinical trial (NCT04053959) have indicated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes.

This multi-center study enrolls 142 patients with Type 2 Diabetes from three sites who are on treatment of diabetes for at least 3 months. They will be randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (iNCDSS group) receive insulin regimen set by iNCDSS and patients in Regular treatment regime group receive insulin regimen recommended by endocrinologists.

This study will be conducted in the Department of Endocrinology in Shanghai Zhongshan Hospital, Shanghai fifth People's Hospital, Shanghai Xuhui Central Hospital, and will consist of a 5-day intervention period. Patient allocation will be stratified by HbA1c and sites. The primary endpoint is the time in target glucose range during the trial period.

Conditions: Type 2 Diabetes
Being tested: iNCDSS based insulin regime, routine insulin treatment regime
Keywords: iNCDSS, T2D, AI
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

iNCDSS based insulin regimeDrug
Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
routine insulin treatment regimeDrug
Patients of this group will receive the insulin regime recommended by professional endocrinologists.

Study groups in NCT04642378
Study group	Role	What they receive
iNCDSS group	Experimental	Artificial intelligence assisted insulin titration system group Receives: Drug: iNCDSS based insulin regime
Routine treatment group	Active comparator	Physician decided insulin titration group Receives: Drug: routine insulin treatment regime

What is being measured

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

Time in target glucose range
The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L)
Measured: During 5-day intervention

Secondary outcomes (3)

Proportion of time in which the blood glucose level is over 10 mmol/L
The poor control of blood glucose level is defined as greater than 10 mmol/L
Measured: During 5-day intervention
Proportion of hypoglycemia
The hypoglycemia is defined as blood glucose level less than 3.0mmol/L
Measured: During 5-day intervention
Daily insulin dose
The daily insulin dose is defined as daily total insulin dose
Measured: During 5-day intervention

Timeline

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

1 Oct 20218 Sep 2022

First posted24 Nov 2020
Study start1 Oct 2021
Primary completion8 Sep 2022
Study completion8 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Shanghai Zhongshan HospitalThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: The intervention group will receive iNCDSS assisted recommendation for insulin dose titration. The control group will receive insulin dose titrated by senior attending physicians.
Masking: Single blind
Who is masked: Participant
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04642378
Sponsor's protocol ID: ZSE-202011
Acronym: iNCDSS-3
Status last verified: Apr 2024
First submitted: 22 Nov 2020
Last updated: 16 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
PubMed 24002281
Wang T, Xu Y, Xu M, Wang W, Bi Y, Lu J, Dai M, Zhang D, Ding L, Xu B, Sun J, Zhao W, Jiang Y, Wang L, Li Y, Zhang M, Lai S, Wang L, Ning G. Awareness, treatment and control of cardiometabolic disorders in Chinese adults with diabetes: a national representative population study. Cardiovasc Diabetol. 2015 Feb 26;14:28. doi: 10.1186/s12933-015-0191-6.
PubMed 25848699
Ji LN, Lu JM, Guo XH, Yang WY, Weng JP, Jia WP, Zou DJ, Zhou ZG, Yu DM, Liu J, Shan ZY, Yang YZ, Hu RM, Zhu DL, Yang LY, Chen L, Zhao ZG, Li QF, Tian HM, Ji QH, Liu J, Ge JP, Shi LX, Xu YC. Glycemic control among patients in China with type 2 diabetes mellitus receiving oral drugs or injectables. BMC Public Health. 2013 Jun 21;13:602. doi: 10.1186/1471-2458-13-602.
PubMed 23800082
Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.
PubMed 15920040
Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Trippe BS; INITIATEplus Study Group. A(1c) control in a primary care setting: self-titrating an insulin analog pre-mix (INITIATEplus trial). Am J Med. 2009 Nov;122(11):1043-9. doi: 10.1016/j.amjmed.2008.12.026.
PubMed 19854333
Yang W, Zhu L, Meng B, Liu Y, Wang W, Ye S, Sun L, Miao H, Guo L, Wang Z, Lv X, Li Q, Ji Q, Zhao W, Yang G. Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial. J Diabetes Investig. 2016 Jan;7(1):85-93. doi: 10.1111/jdi.12364. Epub 2015 May 25.
PubMed 26816605
Harris S, Yale JF, Dempsey E, Gerstein H. Can family physicians help patients initiate basal insulin therapy successfully?: randomized trial of patient-titrated insulin glargine compared with standard oral therapy: lessons for family practice from the Canadian INSIGHT trial. Can Fam Physician. 2008 Apr;54(4):550-8.
PubMed 18411384
Rigla M, Garcia-Saez G, Pons B, Hernando ME. Artificial Intelligence Methodologies and Their Application to Diabetes. J Diabetes Sci Technol. 2018 Mar;12(2):303-310. doi: 10.1177/1932296817710475. Epub 2017 May 25.
PubMed 28539087
Ashrafzadeh S, Hamdy O. Patient-Driven Diabetes Care of the Future in the Technology Era. Cell Metab. 2019 Mar 5;29(3):564-575. doi: 10.1016/j.cmet.2018.09.005. Epub 2018 Sep 27.
PubMed 30269984
Thabit H, Hartnell S, Allen JM, Lake A, Wilinska ME, Ruan Y, Evans ML, Coll AP, Hovorka R. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):117-124. doi: 10.1016/S2213-8587(16)30280-7. Epub 2016 Nov 9.
PubMed 27836235
Bally L, Thabit H, Hartnell S, Andereggen E, Ruan Y, Wilinska ME, Evans ML, Wertli MM, Coll AP, Stettler C, Hovorka R. Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care. N Engl J Med. 2018 Aug 9;379(6):547-556. doi: 10.1056/NEJMoa1805233. Epub 2018 Jun 25.
PubMed 29940126
Ying Z, Fan Y, Chen C, Liu Y, Tang Q, Chen Z, Yang Q, Yan H, Wu L, Lu J, Liu Z, Liu J, Li X, Chen Y. Real-Time AI-Assisted Insulin Titration System for Glucose Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258910. doi: 10.1001/jamanetworkopen.2025.8910.
PubMed 40332936

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Assess the Efficacy and Safety of iNCDSS Assisted Insulin Dosage Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients : a Muticenter, Single-blind, Randomized Controlled Study
ClinicalTrials.gov ID: NCT04642378
Acronym / sponsor ID: iNCDSS-3 / ZSE-202011
Conditions: Type 2 Diabetes
Keywords: iNCDSS, T2D, AI
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Collaborators: Fudan University, Xuhui Central Hospital, Shanghai
Study start: 1 Oct 2021 (actual)
Primary completion: 8 Sep 2022 (actual)
Study completion: 8 Sep 2022 (actual)
First posted: 24 Nov 2020 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The intervention group will receive iNCDSS assisted recommendation for insulin dose titration. The control group will receive insulin dose titrated by senior attending physicians.

Arm	Type	Receives
iNCDSS group	Experimental	Drug: iNCDSS based insulin regimeArtificial intelligence assisted insulin titration system group
Routine treatment group	Active comparator	Drug: routine insulin treatment regimePhysician decided insulin titration group

Who may qualify

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

Key inclusion criteria (4 listed)

Men or women aged 18 and above years old;
Subjects who had been diagnosed with type 2 diabetes;
Subjects who are on diabetes treatment for at least 3 months;
HbA1c: 7.0%-11.0%.

Key exclusion criteria (9 listed)

Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
Subjects who change the insulin regimens during hospitalization;
BMI ≥ 45kg/m2;
Women who are pregnant or nursing;
Subjects with severe cardiac, hepatic, renal or general diseases;

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
iNCDSS based insulin regimePatients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).	Drug	iNCDSS group
routine insulin treatment regimePatients of this group will receive the insulin regime recommended by professional endocrinologists.	Drug	Routine treatment group

Primary outcome

Time in target glucose range
Time frame: During 5-day intervention
The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L)

3 secondary outcomes

Proportion of time in which the blood glucose level is over 10 mmol/L
Time frame: During 5-day intervention
Proportion of hypoglycemia
Time frame: During 5-day intervention
Daily insulin dose
Time frame: During 5-day intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Background: PubMed 24002281Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
Background: PubMed 25848699Wang T, Xu Y, Xu M, Wang W, Bi Y, Lu J, Dai M, Zhang D, Ding L, Xu B, Sun J, Zhao W, Jiang Y, Wang L, Li Y, Zhang M, Lai S, Wang L, Ning G. Awareness, treatment and control of cardiometabolic disorders in Chinese adults with diabetes: a national representative population study. Cardiovasc Diabetol. 2015 Feb 26;14:28. doi: 10.1186/s12933-015-0191-6.
Background: PubMed 23800082Ji LN, Lu JM, Guo XH, Yang WY, Weng JP, Jia WP, Zou DJ, Zhou ZG, Yu DM, Liu J, Shan ZY, Yang YZ, Hu RM, Zhu DL, Yang LY, Chen L, Zhao ZG, Li QF, Tian HM, Ji QH, Liu J, Ge JP, Shi LX, Xu YC. Glycemic control among patients in China with type 2 diabetes mellitus receiving oral drugs or injectables. BMC Public Health. 2013 Jun 21;13:602. doi: 10.1186/1471-2458-13-602.
Background: PubMed 15920040Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.
Background: PubMed 19854333Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Trippe BS; INITIATEplus Study Group. A(1c) control in a primary care setting: self-titrating an insulin analog pre-mix (INITIATEplus trial). Am J Med. 2009 Nov;122(11):1043-9. doi: 10.1016/j.amjmed.2008.12.026.
Background: PubMed 26816605Yang W, Zhu L, Meng B, Liu Y, Wang W, Ye S, Sun L, Miao H, Guo L, Wang Z, Lv X, Li Q, Ji Q, Zhao W, Yang G. Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial. J Diabetes Investig. 2016 Jan;7(1):85-93. doi: 10.1111/jdi.12364. Epub 2015 May 25.
Background: PubMed 18411384Harris S, Yale JF, Dempsey E, Gerstein H. Can family physicians help patients initiate basal insulin therapy successfully?: randomized trial of patient-titrated insulin glargine compared with standard oral therapy: lessons for family practice from the Canadian INSIGHT trial. Can Fam Physician. 2008 Apr;54(4):550-8.
Background: PubMed 28539087Rigla M, Garcia-Saez G, Pons B, Hernando ME. Artificial Intelligence Methodologies and Their Application to Diabetes. J Diabetes Sci Technol. 2018 Mar;12(2):303-310. doi: 10.1177/1932296817710475. Epub 2017 May 25.
Background: PubMed 30269984Ashrafzadeh S, Hamdy O. Patient-Driven Diabetes Care of the Future in the Technology Era. Cell Metab. 2019 Mar 5;29(3):564-575. doi: 10.1016/j.cmet.2018.09.005. Epub 2018 Sep 27.
Background: PubMed 27836235Thabit H, Hartnell S, Allen JM, Lake A, Wilinska ME, Ruan Y, Evans ML, Coll AP, Hovorka R. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):117-124. doi: 10.1016/S2213-8587(16)30280-7. Epub 2016 Nov 9.
Background: PubMed 29940126Bally L, Thabit H, Hartnell S, Andereggen E, Ruan Y, Wilinska ME, Evans ML, Wertli MM, Coll AP, Stettler C, Hovorka R. Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care. N Engl J Med. 2018 Aug 9;379(6):547-556. doi: 10.1056/NEJMoa1805233. Epub 2018 Jun 25.
Derived from this study: PubMed 40332936Ying Z, Fan Y, Chen C, Liu Y, Tang Q, Chen Z, Yang Q, Yan H, Wu L, Lu J, Liu Z, Liu J, Li X, Chen Y. Real-Time AI-Assisted Insulin Titration System for Glucose Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258910. doi: 10.1001/jamanetworkopen.2025.8910.
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. This study is not recruiting at the moment.

Xiaoying Li, MD principal investigator

Shanghai Zhongshan Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing iNCDSS based insulin regime and routine insulin treatment regime in people with Type 2 Diabetes, run by Shanghai Zhongshan Hospital at 1 site in China.

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 4 inclusion and 9 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: finished, as of the sponsor's last update on 16 Apr 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in target glucose range (time frame: During 5-day intervention). 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 NCT04642378, which also lists 12 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 16 Apr 2024.