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Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm
Sponsor: Sun Yat-sen University
Summary
The present study aims to conduct a prospective controlled trial comparing an LSTM-based artificial intelligence (AI) prediction model and clinicians' experience in the efficacy and safety of blood glucose control in hospitalized patients with type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin infusion (CSII) treatment in the Department of Endocrinology. The main question it aims to answer is: Is the prediction model superior to or (at least) non-inferior to clinicians' experience? Eligible patients who receive CSII treatment are randomly allocated into the prediction model group and the empirical group. Patients will: 1. Receive CSII treatment as standard of care during hospitalization for 1-2 weeks, where the daily insulin dose regimen is determined by a prediction model or a clinician's experience. 2. Use continuous glucose monitoring (CGM) for glucose tracking. 3. Receive diabetes self-management education covering nutrition and physical activity.
Official title: Validation of Insulin Dose Prediction Model Based on Long Short- Term Memory Artificial Intelligence Algorithm
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-07-15
Completion Date
2026-06
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
CSII in the prediction model group
1. Everyday insulin dosage decided by AI prediction model. 2. CSII treatment continues for 1 to 2 weeks based on whehter or not the patient is newly diagnosed or with different disease duration.
CSII in the empirical group
1. Everyday insulin dosage decided by clinicans' experience. 2. CSII treatment continues for 1 to 2 weeks based on whether or not the patient is newly diagnosed or with different disease duration.
Locations (1)
Department of Endocrinology and Diabetes Center, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China