Artificial Intelligence Assisted Insulin Titration System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: AI assisted insulin system
* Drug: Physician based insulin 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 patients
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI Group<br>Artificial intelligence assisted insulin titration system group | Drug: AI assisted insulin system<br>* The patients receive the insulin regime set by AI assisted insulin titration system<br>|
| Active Comparator: Control Group<br>Physicians decided insulin titration group | Drug: Physician based insulin regime<br>* Patients receive the insulin regime recommended by physicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of time in target 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 time in which the blood glucose level is below 3.9 mmol/L | 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 | Each day during 7-day intervention |