Insulin Titration System Based on Deep Learning

Diabetes Mellitus Type 2 - Insulin-Treated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409391
• Other study ID #: ZSE-202205
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: October 6, 2022

Study information

• Verified date: June 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 - Insulin-Treated
• Diabetes Mellitus, Type 2

Intervention

Device:
• Insulin Titration System
A noval insulin titration system, which is based on deep learning

Locations

Country	Name	City	State
China	Department of Endocrinology, Zhongshan Hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	glucose concentration in target range (TIR) of 3.9-10.0 mmol/L	TIR measured by CGM and Capillary glucose measurements, respectively	5 days
Secondary	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
Secondary	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
Secondary	glycemic variability	glycemic variability measured by CGM and Capillary glucose measurements, respectively	5 days