Insulin Titration System Based on Deep Learning

• ClinicalTrials.gov Identifier: NCT05409391
• Recruitment Status: Completed
• First Posted: June 8, 2022
• Last Update Posted: June 7, 2023
• Sponsor: Shanghai Zhongshan Hospital
• Information provided by (Responsible Party): Xiaoying Li, Shanghai Zhongshan Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus Type 2 - Insulin-Treated	Device: Insulin Titration System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 15, 2022
• Actual Primary Completion Date: October 6, 2022
• Actual Study Completion Date: October 6, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. mean daily blood glucose concentration [ Time Frame: 5 days ]
   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.

Secondary Outcome Measures :

1. glucose concentration in target range (TIR) of 3.9-10.0 mmol/L [ Time Frame: 5 days ]
   TIR measured by CGM and Capillary glucose measurements, respectively
2. glucose concentration above range (10.1-13.9 mmol/L or >13.9 mmol/L) [ Time Frame: 5 days ]
   TAR measured by CGM and Capillary glucose measurements, respectively
3. glucose concentration below range (3.0-3.8 mmol/L or <3.0 mmol/L) [ Time Frame: 5 days ]
   TBR measured by CGM and Capillary glucose measurements, respectively
4. glycemic variability [ Time Frame: 5 days ]
   glycemic variability measured by CGM and Capillary glucose measurements, respectively

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

China

Department of Endocrinology, Zhongshan Hospital Fudan University

Shanghai, China

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

• Principal Investigator: Xiaoying Li; Shanghai Zhongshan Hospital

More Information

• Responsible Party: Xiaoying Li, Professor, Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT05409391
• Other Study ID Numbers: ZSE-202205
• First Posted: June 8, 2022
• Last Update Posted: June 7, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs