AI-Assisted Insulin Titration System on Inpatients Glucose Control

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04517201
• Other study ID #: iNCDSS-2
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Hua Bian
• Phone: +8613681976102
• Email: bianhuaer[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View Citation

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. Review. — View Citation

Rawshani A, Rawshani A, Gudbjörnsdottir 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting plasma glucose of T2D patients	Fasting plasma glucose of T2D patients by self-monitoring of bloodglucose (SMBG) in both groups	After 7-day intervention
Secondary	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	During 7-day intervention
Secondary	Incidence of hypoglycemia	The hypoglycemia is defined as blood glucose level less than 3.9mmol/L.	During 7-day intervention
Secondary	Total insulin dose	The total insulin dose is defined as daily insulin dose.	During 7-day intervention

External Links

•   IDF DIABETES ATLAS-7TH EDITION.