Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: iNCDSS based insulin regime
* Drug: routine insulin treatment regime


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention group will receive iNCDSS assisted recommendation for insulin dose titration. The control group will receive insulin dose titrated by senior attending physicians.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iNCDSS group<br>Artificial intelligence assisted insulin titration system group | Drug: iNCDSS based insulin regime<br>* Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).<br>* Other names: iGMS + iNCDSS based insulin regime;|
| Active Comparator: Routine treatment group<br>Physician decided insulin titration group | Drug: routine insulin treatment regime<br>* Patients of this group will receive the insulin regime recommended by professional endocrinologists.<br>* Other names: iGMS + routine insulin treatment regime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in target glucose range | 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 | The poor control of blood glucose level is defined as greater than 10 mmol/L | During 7-day intervention | 
| Proportion of hypoglycemia | The hypoglycemia is defined as blood glucose level less than 3.9mmol/L | During 7-day intervention | 
| Daily insulin dose | The daily insulin dose is defined as daily total insulin dose | During 7-day intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iNCDSS, T2D, AI