AI-Assisted Insulin Titration System on Inpatients Glucose Control

Study Overview
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Brief Summary
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This is a multi-center, open-labeled, 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 demonstrated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes. This multi-center study enrolls 120 patients with Type 2 Diabetes from 20 wards of 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 (AI group) receive insulin regimen set by iNCDSS and patients in Control group receive insulin regimen recommended by endocrinologists. 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 fasting plasma glucose level after the 7-days trial period.

Official Title
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Study to Assess Artificial Intelligence-Assisted Insulin Titration System on Inpatients Glucose Control

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: iNCDSS based insulin regime
* Drug: Physician based insulin regime


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 18-99 years old; Inpatients who had been diagnosed with type 2 diabetes; Subjects who are on treatment with insulin for at least 3 months; HbA1c: 7.0%-10.0%. Exclusion Criteria: Patients who were diagnosed with T1D, gestational diabetes or other specific types of diabetes. Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state; Patients with severe cardiac, hepatic, renal or general diseases; Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol. Absence of informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI group<br>iGMS+iNCDSS group (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: Control group<br>iGMS+routine treatment group (Physicians decided insulin titration group) | Drug: Physician based insulin 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 |
| --- | --- | --- |
| Fasting plasma glucose of T2D patients | Fasting plasma glucose of T2D patients by self-monitoring of bloodglucose (SMBG) in both groups | After 7-day intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-controlled rate of fasting blood glucose | The well-controlled rate of blood glucose is defined as proportion of the time of sensor glucose measurements in targeted range | During 7-day intervention | 
| Incidence of hypoglycemia | The hypoglycemia is defined as blood glucose level less than 3.9mmol/L. | During 7-day intervention | 
| Total insulin dose | The total insulin dose is defined as daily 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