AI-Assisted Insulin Titration System on Inpatients Glucose Control

March 18, 2021 updated by: Hua Bian, Shanghai Zhongshan Hospital

Study to Assess Artificial Intelligence-Assisted Insulin Titration System on Inpatients Glucose Control

This is a multi-center, open-labeled, 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

Recruiting

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 demonstrated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes.

This multi-center study enrolls 120 patients with Type 2 Diabetes from 20 wards of Zhongshan Hospital who are on treatment with insulin for at least 3 months. They are randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (AI group) receive insulin regimen set by iNCDSS and patients in Control group receive insulin regimen recommended by endocrinologists.

This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University and 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 fasting plasma glucose level after the 7-days trial period.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • ZhongShan Hospital
        • Contact:

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women aged 18-99 years old;
  • Inpatients who had been diagnosed with type 2 diabetes;
  • Subjects who are on treatment with insulin for at least 3 months;
  • HbA1c: 7.0%-10.0%.

Exclusion Criteria:

  • Patients who were diagnosed with T1D, gestational diabetes or other specific types of diabetes.
  • Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
  • Patients with severe cardiac, hepatic, renal or general diseases;
  • Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.
  • Absence of informed consent.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI group
iGMS+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: Control group
iGMS+routine treatment group (Physicians decided insulin titration group)
Drug: Physician based insulin 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
Fasting plasma glucose of T2D patients
Time Frame: After 7-day intervention
Fasting plasma glucose of T2D patients by self-monitoring of bloodglucose (SMBG) in both groups
After 7-day intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Well-controlled rate of fasting blood glucose
Time Frame: During 7-day intervention
The well-controlled rate of blood glucose is defined as proportion of the time of sensor glucose measurements in targeted range
During 7-day intervention
Incidence of hypoglycemia
Time Frame: During 7-day intervention
The hypoglycemia is defined as blood glucose level less than 3.9mmol/L.
During 7-day intervention
Total insulin dose
Time Frame: During 7-day intervention
The total insulin dose is defined as daily insulin dose.
During 7-day intervention

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Hua Bian, 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)

November 4, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iNCDSS-2

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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