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RECRUITING
NCT07066891
NA

Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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