Artificial Intelligence Assisted Insulin Titration System (iNCDSS)

July 24, 2020 updated by: Shanghai Zhongshan Hospital

A Study to Assess the Effect and Safety of Artificial Intelligence Assisted Insulin Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients: A Single-center, Open-labeled, Parallel, Randomized Controlled Trial

This is a single-center, open-labeled, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System in patients with Type 2 Diabetes Mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study enrolls 44 patients with Type 2 Diabetes in 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 receive insulin regimen set by the AI assisted system and patients in Control group receive insulin regimen set by physicians. 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 percentage of time of sensor glucose measurements in targeted range (3.9-10 mmol/L) during the 7-days trial period.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

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

Genders Eligible for Study

All

Description

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.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI Group
Artificial intelligence assisted insulin titration system group
Drug: AI assisted insulin system
The patients receive the insulin regime set by AI assisted insulin titration system
Active Comparator: Control Group
Physicians decided insulin titration group
Drug: Physician based insulin regime
Patients receive the insulin regime recommended by physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of time in target range
Time Frame: 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)
During 7-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 7-day intervention
The poor control of blood glucose level is defined as greater than 10 mmol/L
During 7-day intervention
Proportion of time in which the blood glucose level is below 3.9 mmol/L
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: Each day during 7-day intervention
The total insulin dose is defined as daily insulin dose
Each day during 7-day intervention

Collaborators and Investigators

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

Sponsor

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)

September 27, 2019

Primary Completion (Actual)

January 22, 2020

Study Completion (Actual)

April 15, 2020

Study Registration Dates

First Submitted

August 10, 2019

First Submitted That Met QC Criteria

August 10, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSE-201902

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

product manufactured in and exported from the U.S.

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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