Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients (iNCDSS-3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04642378|
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: iNCDSS based insulin regime Drug: routine insulin treatment regime||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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)
- 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
- Proportion of hypoglycemia [ Time Frame: During 7-day intervention ]The hypoglycemia is defined as blood glucose level less than 3.9mmol/L
- Daily insulin dose [ Time Frame: During 7-day intervention ]The daily insulin dose is defined as daily total insulin dose
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
|Contact: Ying Chen, MDfirstname.lastname@example.org|
|180 Fenglin Road|
|Shanghai, China, 200032|
|Principal Investigator:||Xiaoying Li, MD||Shanghai Zhongshan Hospital|