Trial | NCT04642378  Report issue

Title

Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    106
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.
Study Started
Oct 01
2021
Primary Completion
Jun 30
2022
Anticipated
Study Completion
Oct 30
2022
Anticipated
Last Update
Apr 08
2022

Drug iNCDSS based insulin regime

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

  • Other names: iGMS + iNCDSS based insulin regime

Drug routine insulin treatment regime

Patients of this group will receive the insulin regime recommended by professional endocrinologists.

  • Other names: iGMS + routine insulin treatment regime

iNCDSS group Experimental

Artificial intelligence assisted insulin titration system group

Routine treatment group Active Comparator

Physician decided insulin titration group

Criteria 

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.
No Results Posted