Insulin Titration System Based on Deep Learning

Study Overview
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Brief Summary
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This is an open-labeled, one-arm intervention trial to access the effect and safety of the Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus.

Detailed Description
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The study enrolls 13 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin. After screening for the inclusion and exclusion criteria, eligible patients will receive insulin dosage titration set by the Insulin Titration System Based on Deep Learning in the intervention trial. The goal of insulin therapy was to achieve preprandial capillary blood glucose between 5.6-7.8 mmol/L and postprandial capillary glucose less than 10.0mmol/L. All patients are studied for 5 consecutive days or untill hospital discharge. For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. And continuous glucose monitoring (CGM) was performed using flash glucose monitoring (Abbott Freestyle Libre, USA) placed on the upper left arm. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University.

Official Title
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Study to Assess the Efficacy and Safety of Insulin Titration System Based on Deep Learning on Glucose Control in Type 2 Diabetes Mellitus Patients

Conditions
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Diabetes Mellitus Type 2 - Insulin-Treated

Intervention / Treatment
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* Device: Insulin Titration System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes age of 18-75 years HbA1c between 7.0% and 11.0%. Exclusion Criteria: subjects with acute complications of diabetes, such as ketoacidosis or hyperglycemic hyperosmolar state; BMI ≥ 45kg/m2; women who are pregnant or breast-feeding; subjects with severe cardiac, hepatic, renal diseases; subjects with any psychiatric or psychological diseases; subjects with severe edema, infections or peripheral circulation disorders, receiving surgery during hospitalization; subjects who could not 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI<br>Insulin Titration System Based on Deep Learning | Device: Insulin Titration System<br>* A noval insulin titration system, which is based on deep learning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean daily blood glucose concentration | For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. The primary outcome is the difference in glycemia control as measured by mean daily blood glucose concentration during the intervention period. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose concentration in target range (TIR) of 3.9-10.0 mmol/L | TIR measured by CGM and Capillary glucose measurements, respectively | 5 days | 
| glucose concentration above range (10.1-13.9 mmol/L or >13.9 mmol/L) | TAR measured by CGM and Capillary glucose measurements, respectively | 5 days | 
| glucose concentration below range (3.0-3.8 mmol/L or <3.0 mmol/L) | TBR measured by CGM and Capillary glucose measurements, respectively | 5 days | 
| glycemic variability | glycemic variability measured by CGM and Capillary glucose measurements, respectively | 5 days |