Insulin Titration System Based on Deep Learning

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2 - Insulin-Treated
• Intervention / Treatment: Device: Insulin Titration System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Department of Endocrinology, Zhongshan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Xiaoying Li, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: ZSE-202205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No