AI-Assisted Insulin Titration System on Inpatients Glucose Control

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Drug: Physician based insulin regime; Drug: iNCDSS based insulin regime

• Registration Number: NCT04517201
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-18
• Study Start: 2020-11-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-23
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Physician based insulin regime	iGMS+routine treatment group (Physicians decided insulin titration group)
AI group	iNCDSS based insulin regime	iGMS+iNCDSS group (Artificial intelligence assisted insulin titration system group)

Primary Outcome Measures

Name	Time	Method
Fasting plasma glucose of T2D patients	After 7-day intervention	Fasting plasma glucose of T2D patients by self-monitoring of bloodglucose (SMBG) in both groups

Secondary Outcome Measures

Name	Time	Method
Well-controlled rate of fasting blood glucose	During 7-day intervention	The well-controlled rate of blood glucose is defined as proportion of the time of sensor glucose measurements in targeted range
Incidence of hypoglycemia	During 7-day intervention	The hypoglycemia is defined as blood glucose level less than 3.9mmol/L.
Total insulin dose	During 7-day intervention	The total insulin dose is defined as daily insulin dose.

Trial Locations

Locations (2)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China