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Validation of Insulin Dose Prediction Model Based on Long Short- Term Memory Artificial Intelligence Algorithm
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.
Details
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 400 |
| Start date | 2025-07-15 |
| Completion | 2026-06 |
Conditions
- Diabetes Mellitus
- Type 2 Diabetes
Interventions
- CSII in the prediction model group
- CSII in the empirical group
Primary outcomes
- Time in range — During continuous subcutaneous insulin infusion treatment period（assessed up to 2 weeks, the treatment period between the initiation and suspension of the insulin pump)
Time in range refers to the percentage time in range between 3.9mmol/L and 10.0 mmol/L in continuous glucose monitoring data during the continuous subcutaneous insulin infusion treatment period. - Time below range — During continuous subcutaneous insulin infusion treatment period（assessed up to 2 weeks, the treatment period between the initiation and suspension of the insulin pump)
Time below range refers to percentage time of glucose\<3.9mmol/L in continuous glucose monitoring data during the continuous subcutaneous insulin infusion treatment period.
Countries
China