This is a multi-center, single-blind, 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 indicated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes. This multi-center study enrolls 142 patients with Type 2 Diabetes from three sites who are on treatment of diabetes for at least 3 months. They will be randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (iNCDSS group) receive insulin regimen set by iNCDSS and patients in Regular treatment regime group receive insulin regimen recommended by endocrinologists. This study will be conducted in the Department of Endocrinology in Shanghai Zhongshan Hospital, Shanghai fifth People's Hospital, Shanghai Xuhui Central Hospital, and will consist of a 5-day intervention period. Patient allocation will be stratified by HbA1c and sites. The primary endpoint is the time in target glucose range during the trial period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
149
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.
180 Fenglin Road
Shanghai, China
Time in target glucose range
The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L)
Time frame: During 5-day intervention
Proportion of time in which the blood glucose level is over 10 mmol/L
The poor control of blood glucose level is defined as greater than 10 mmol/L
Time frame: During 5-day intervention
Proportion of hypoglycemia
The hypoglycemia is defined as blood glucose level less than 3.0mmol/L
Time frame: During 5-day intervention
Daily insulin dose
The daily insulin dose is defined as daily total insulin dose
Time frame: During 5-day intervention
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