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

April 14, 2024 updated by: Xiaoying Li, Shanghai Zhongshan Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • 180 Fenglin Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women aged 18 and above years old;
  • Subjects who had been diagnosed with type 2 diabetes;
  • Subjects who are on diabetes treatment 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in target glucose range
Time Frame: During 5-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)
During 5-day intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of time in which the blood glucose level is over 10 mmol/L
Time Frame: During 5-day intervention
The poor control of blood glucose level is defined as greater than 10 mmol/L
During 5-day intervention
Proportion of hypoglycemia
Time Frame: During 5-day intervention
The hypoglycemia is defined as blood glucose level less than 3.0mmol/L
During 5-day intervention
Daily insulin dose
Time Frame: During 5-day intervention
The daily insulin dose is defined as daily total insulin dose
During 5-day intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Shanghai Fifth People's Hospital,Fudan University
XuHui Central Hospital of Shanghai, Shanghai, China

Investigators

  • Principal Investigator: Xiaoying Li, MD, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

September 8, 2022

Study Completion (Actual)

September 8, 2022

Study Registration Dates

First Submitted

November 22, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSE-202011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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