Actively Recruiting
Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm
Led by Sun Yat-sen University · Updated on 2025-08-14
400
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus according to Chinese Guidelines for Prevention and Treatment of Type 2 Diabetes (2020 edition)
- Using insulin pump (CSII) to control blood glucose during hospitalization
- CSII treatment duration between 6 and less than 30 days
- Age between 18 and 75 years
You will not qualify if you...
- Diabetes other than type 2
- Age 75 years or older and unsuitable for intensive insulin therapy
- Using hypoglycemic treatments other than CSII during hospitalization, such as oral drugs or multiple daily insulin injections
- Severe infection or uncontrolled acute complications, including ketoacidosis coma or hyperosmolar hyperglycemia, or any condition deemed unsuitable by the researcher
- Severe liver or kidney failure (ALT 5 times above normal or eGFR below 30 ml/min/1.73m2)
- Acute cardiovascular or cerebrovascular diseases considered unsuitable for study
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Endocrinology and Diabetes Center, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
Z
Zhimin Huang, MD. & PhD.
CONTACT
Y
Yuping Cao, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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