AI-Assisted Insulin Titration System on Inpatients Glucose Control

NCT ID: NCT04517201

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2021-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AI group

iGMS+iNCDSS group (Artificial intelligence assisted insulin titration system group)

Group Type: EXPERIMENTAL

iNCDSS based insulin regime

Intervention Type: DRUG

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

Control group

iGMS+routine treatment group (Physicians decided insulin titration group)

Group Type: ACTIVE_COMPARATOR

Physician based insulin regime

Intervention Type: DRUG

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

Interventions

iNCDSS based insulin regime

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

Intervention Type: DRUG

Physician based insulin regime

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

Intervention Type: DRUG

Other Intervention Names

iGMS + iNCDSS based insulin regime; iGMS + routine insulin treatment regime

Eligibility Criteria

Inclusion Criteria

• 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%.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hua Bian

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hua Bian

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua Bian

Role: CONTACT

bianhuaer@126.com

+8613681976102

Facility Contacts

Hua Bian, chief physician

Role: primary

bianhuaer@126.com

Hua Bian

Role: primary

bianhuaer@126.com

+8613681976102

References

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.

Reference Type: BACKGROUND

PMID: 24002281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25848699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26246173 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28723317 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29848472 (View on PubMed)

Other Identifiers

iNCDSS-2

Identifier Type: -

Identifier Source: org_study_id