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iNCDSS: Artificial Intelligence Assisted Insulin Titration System

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04053959
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
6.6
Actual Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: AI assisted insulin system
  • Drug: Physician based insulin regime
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A paralle group, randomized, controlled study to assess the effect and safety of artificial intelligence assisted insulin dosage titration system on glucose control in type 2 diabetic patientsA paralle group, randomized, controlled study to assess the effect and safety of artificial intelligence assisted insulin dosage titration system on glucose control in type 2 diabetic patients
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The research assistants who collect study outcome data will be masked to participants' intervention assignment. In addition, the adjudicators for end-points will not be aware of study-group assignments.
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 27, 2019
Actual Primary Completion Date :
Jan 22, 2020
Actual Study Completion Date :
Apr 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of time in target 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

  1. 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

  2. Proportion of time in which the blood glucose level is below 3.9 mmol/L [During 7-day intervention]

    The hypoglycemia is defined as blood glucose level less than 3.9mmol/L

  3. Total insulin dose [Each day during 7-day intervention]

    The total insulin dose is defined as daily insulin dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 180 Fenglin Road Shanghai China 200032

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Xiaoying Li, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT04053959
Other Study ID Numbers:
  • ZSE-201902
First Posted:
Aug 13, 2019
Last Update Posted:
Jul 27, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin
Insulin, Globin Zinc

Study Results

No Results Posted as of Jul 27, 2020