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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
Patients of this group will receive the insulin regime recommended by professional endocrinologists.
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGFasting plasma glucose of T2D patients
Fasting plasma glucose of T2D patients by self-monitoring of bloodglucose (SMBG) in both groups
Time frame: After 7-day intervention
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
Time frame: During 7-day intervention
Incidence of hypoglycemia
The hypoglycemia is defined as blood glucose level less than 3.9mmol/L.
Time frame: During 7-day intervention
Total insulin dose
The total insulin dose is defined as daily insulin dose.
Time frame: During 7-day intervention
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