NCT07066891Terminated
Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm
Validation of Insulin Dose Prediction Model Based on Long Short- Term Memory Artificial Intelligence Algorithm
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Reason given: Recruitment was stopped early because hospital length-of-stay constraints limited protocol delivery. The PI's decision also took account of the available non-inferiority results.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 203 (actual)
- First submitted
- 7 Jun 2025
- Start date
- 15 Jul 2025
- Primary completion date
- 5 Dec 2025
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07066891
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hypoglycemic regimen other than CSII treatment, such as oral hypoglycemic drugs or multiple daily insulin injections during hospitalization.
Other illness
- Diabetes other than type 2.
- 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.
Lab values
- 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.
Age
- Age ≥75 years who is not suitable for intensive insulin therapy.
Other
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology and Diabetes Center, The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.