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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04642378

Collaborator

(none)

106

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: iNCDSS based insulin regime Drug: routine insulin treatment regime	N/A

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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iNCDSS group Artificial intelligence assisted insulin titration system group	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
Active Comparator: Routine treatment group Physician decided insulin titration group	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

Arm

Intervention/Treatment

Experimental: iNCDSS group

Artificial intelligence assisted insulin titration system group

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

Active Comparator: Routine treatment group

Physician decided insulin titration group

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

Outcome Measures

Primary Outcome Measures

Time in target glucose range [During 7-day intervention]
The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L)

Secondary Outcome Measures

Proportion of time in which the blood glucose level is over 10 mmol/L [During 7-day intervention]
The poor control of blood glucose level is defined as greater than 10 mmol/L
Proportion of hypoglycemia [During 7-day intervention]
The hypoglycemia is defined as blood glucose level less than 3.9mmol/L
Daily insulin dose [During 7-day intervention]
The daily insulin dose is defined as daily total insulin dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.