Clinical trial NCT05409391: Insulin Titration System Based on Deep Learning
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2 - Insulin-Treated
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: mean daily blood glucose concentration
timeFrame: 5 days
Secondary outcomes:
measure: glucose concentration in target range (TIR) of 3.9-10.0 mmol/L
timeFrame: 5 days
measure: glucose concentration above range (10.1-13.9 mmol/L or >13.9 mmol/L)
timeFrame: 5 days
measure: glucose concentration below range (3.0-3.8 mmol/L or <3.0 mmol/L)
timeFrame: 5 days
measure: glycemic variability
timeFrame: 5 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Zhongshan Hospital Fudan University
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Xiaoying Li
role: PRINCIPAL_INVESTIGATOR
References: