Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients (iNCDSS-3)

Study to Assess the Efficacy and Safety of iNCDSS Assisted Insulin Dosage Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients : a Muticenter, Single-blind, Randomized Controlled Study

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 106 patients with Type 2 Diabetes from four sites who are on treatment with insulin 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 Shanghai Qingpu Central Hospital, and will 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 time in target glucose range during the 7-day trial period.

The intervention group will receive iNCDSS assisted recommendation for insulin dose titration. The control group will receive insulin dose titrated by senior attending physicians.

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

The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L)

Inclusion Criteria: Men or women aged 18-75 years old; Subjects who had been diagnosed with type 2 diabetes; Subjects who are on treatment with insulin for at least 3 months; HbA1c: 7.0%-11.0%. Exclusion Criteria: Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state; Subjects who change the insulin regimens during hospitalization; BMI ≥ 45kg/m2; Women who are pregnant or nursing; Subjects with severe cardiac, hepatic, renal or general diseases; Subjects with psychiatric disorders or impaired cognitive function; Subjects with severe edema, infections or peripheral circulation disorders; Patients treated with surgery during hospitalization; Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.

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