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

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ClinicalTrials.gov Identifier: NCT04642378
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
Shanghai Fifth People's Hospital
Shanghai Xuhui Central Hospital
Shanghai Qingpu Central Hospital
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: iGMS + routine insulin treatment regime




Primary Outcome Measures :
  1. Time in target glucose 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)


Secondary Outcome Measures :
  1. 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

  2. Proportion of hypoglycemia [ Time Frame: During 7-day intervention ]
    The hypoglycemia is defined as blood glucose level less than 3.9mmol/L

  3. Daily insulin dose [ Time Frame: During 7-day intervention ]
    The daily insulin dose is defined as daily total insulin dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642378


Contacts
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Contact: Ying Chen, MD 15351890068 baiyuan9873@163.com

Locations
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China
180 Fenglin Road
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Shanghai Fifth People's Hospital
Shanghai Xuhui Central Hospital
Shanghai Qingpu Central Hospital
Investigators
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Principal Investigator: Xiaoying Li, MD Shanghai Zhongshan Hospital
Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04642378    
Other Study ID Numbers: ZSE-202011
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
iNCDSS
T2D
AI
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs