Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm
Recruiting now · Not applicable
Conditions studied: Diabetes Mellitus, Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT07066891
- Run by
- Sun Yat-sen University
- People needed
- 400
- Starts
- 2025-07-15
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-08-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Meets the diagnostic criteria of type 2 diabetes mellitus in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition).
- Insulin pump is used to control blood glucose during hospitalization, and the duration of CSII treatment period ≥6 days and <30 days.
You may not qualify if…
- Diabetes other than type 2.
- Age ≥75 years who is not suitable for intensive insulin therapy.
- Hypoglycemic regimen other than CSII treatment, such as oral hypoglycemic drugs or multiple daily insulin injections during hospitalization.
- With severe infection or uncontrolled acute complications (including ketoacidosis coma, hyperosmolar hyperglycemia, etc.) , or any condition that the researcher believes not suitable for the study.
- Severe hepatic and renal insufficiency (ALT≥5 times the upper limit of normal, eGFR<30ml/min/1.73m2) ), or patients at the acute stage of cardiovascular and cerebrovascular diseases considered unsuitable for study.
- Pregnancy.
Where it is running
- Department of Endocrinology and Diabetes Center, The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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