AI-Assisted Insulin Titration System on Inpatients Glucose Control

NCT04517201 | Unknown

• 1 other identifier: iNCDSS-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Keywords

iNCDSS; T2D; AI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Well-controlled rate of fasting blood glucose

  During 7-day intervention

• Incidence of hypoglycemia

  During 7-day intervention

• Total insulin dose

  During 7-day intervention

Study Arms (2)

AI group

EXPERIMENTAL

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

Drug: iNCDSS based insulin regime

Control group

ACTIVE COMPARATOR

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

Drug: Physician based insulin regime

Interventions

iNCDSS based insulin regime DRUG

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

Also known as: iGMS + iNCDSS based insulin regime

AI group

Physician based insulin regime DRUG

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

Also known as: iGMS + routine insulin treatment regime

Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (2)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 24002281 BACKGROUND

• 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.

  PMID: 25848699 BACKGROUND

• 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.

  PMID: 26246173 BACKGROUND

• 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.

  PMID: 28723317 BACKGROUND

• 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.

  PMID: 29848472 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hua Bian

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Bian

CONTACT

+8613681976102; bianhuaer@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: November 4, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)