NCT04517201

AI-Assisted Insulin Titration System on Inpatients Glucose Control

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	iNCDSS based insulin regime	Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
DRUG	Physician based insulin regime	Patients of this group will receive the insulin regime recommended by professional endocrinologists.

Timeline

• Start date: 2020-11-04
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-08-18
• Last updated: 2021-03-23

Locations

2 sites across 1 country: China