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Type 2 DiabetesNCT04517201

AI-Assisted Insulin Titration System on Inpatients Glucose Control

A study testing iNCDSS based insulin regime and Physician based insulin regime in people with Type 2 Diabetes, run by Shanghai Zhongshan Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multi-center, open-labeled, 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 to 99 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
iNCDSS based insulin regime and Physician based insulin regime
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesChina
Study dates
4 Nov 2020to Dec 2021
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women aged 18-99 years old;
  • Inpatients who had been diagnosed with type 2 diabetes;
  • Subjects who are on treatment with insulin for at least 3 months;
  • HbA1c: 7.0%-10.0%.

Who cannot join

  • Patients who were diagnosed with T1D, gestational diabetes or other specific types of diabetes.
  • Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
  • Patients with severe cardiac, hepatic, renal or general diseases;
  • Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.
  • Absence of informed consent.

Trial locations and contacts

2 sites in 1 country.

Hua Bian contact

+8613681976102

bianhuaer@126.com

China2 sites, 2 recruiting

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

    Hua Bian, chief physician, bianhuaer@126.com

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai

    Hua Bian, +8613681976102, bianhuaer@126.com

    Recruiting

Other trials in China

About this study

Official title: Study to Assess Artificial Intelligence-Assisted Insulin Titration System on Inpatients Glucose Control

This is a multi-center, open-labeled, 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 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 demonstrated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes.

This multi-center study enrolls 120 patients with Type 2 Diabetes from 20 wards of Zhongshan Hospital who are on treatment with insulin for at least 3 months. They are randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (AI group) receive insulin regimen set by iNCDSS and patients in Control group receive insulin regimen recommended by endocrinologists.

This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University and consist of a 7-day intervention period. Patient allocation will be stratified by HbA1c, BMI and previous total insulin doses. The primary endpoint is the fasting plasma glucose level after the 7-days trial period.

Conditions
Type 2 Diabetes
Being tested
iNCDSS based insulin regime, Physician based insulin 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

    Also called iGMS + iNCDSS based insulin regime

    Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).

  • Physician based insulin regimeDrug

    Also called iGMS + routine insulin treatment regime

    Patients of this group will receive the insulin regime recommended by professional endocrinologists.

Study groups in NCT04517201
Study groupRoleWhat they receive
AI groupExperimentaliGMS+iNCDSS group (Artificial intelligence assisted insulin titration system group)
Receives: Drug: iNCDSS based insulin regime
Control groupActive comparatoriGMS+routine treatment group (Physicians decided insulin titration group)
Receives: Drug: Physician based insulin regime

What is being measured

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

  1. Fasting plasma glucose of T2D patients

    Fasting plasma glucose of T2D patients by self-monitoring of bloodglucose (SMBG) in both groups

    Measured: After 7-day intervention

Secondary outcomes (3)

  1. Well-controlled rate of fasting blood glucose

    The well-controlled rate of blood glucose is defined as proportion of the time of sensor glucose measurements in targeted range

    Measured: During 7-day intervention

  2. Incidence of hypoglycemia

    The hypoglycemia is defined as blood glucose level less than 3.9mmol/L.

    Measured: During 7-day intervention

  3. Total insulin dose

    The total insulin dose is defined as daily insulin dose.

    Measured: During 7-day intervention

Timeline

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

  1. First posted18 Aug 2020
  2. Study start4 Nov 2020
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04517201
Sponsor's protocol ID
iNCDSS-2
Status last verified
Mar 2021
First submitted
14 Aug 2020
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
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

  • Fox CS, Golden SH, Anderson C, Bray GA, Burke LE, de Boer IH, Deedwania P, Eckel RH, Ershow AG, Fradkin J, Inzucchi SE, Kosiborod M, Nelson RG, Patel MJ, Pignone M, Quinn L, Schauer PR, Selvin E, Vafiadis DK; American Heart Association Diabetes Committee of the Council on Lifestyle and Cardiometabolic Health, Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Surgery and Anesthesia, Council on Quality of Care and Outcomes Research, and the American Diabetes Association. Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence: A Scientific Statement From the American Heart Association and the American Diabetes Association. Circulation. 2015 Aug 25;132(8):691-718. doi: 10.1161/CIR.0000000000000230. Epub 2015 Aug 5.

    PubMed 26246173

  • Rawshani A, Rawshani A, Gudbjornsdottir S. Mortality and Cardiovascular Disease in Type 1 and Type 2 Diabetes. N Engl J Med. 2017 Jul 20;377(3):300-301. doi: 10.1056/NEJMc1706292. No abstract available.

    PubMed 28723317

  • Contreras I, Vehi J. Artificial Intelligence for Diabetes Management and Decision Support: Literature Review. J Med Internet Res. 2018 May 30;20(5):e10775. doi: 10.2196/10775.

    PubMed 29848472

Questions about this trial

What is this clinical trial studying?

A study testing iNCDSS based insulin regime and Physician based insulin regime in people with Type 2 Diabetes, run by Shanghai Zhongshan Hospital at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

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

Contact Hua Bian (+8613681976102, bianhuaer@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting plasma glucose of T2D patients (time frame: After 7-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 NCT04517201, which also lists 5 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 23 Mar 2021.

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