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Search / Trial NCT07066891

Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm

Launched by SUN YAT-SEN UNIVERSITY · Jul 12, 2025

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Long Short Term Memory Type 2 Diabetes Mellitus Continuous Subcutaneous Insulin Infusion Intensive Insulin Therapy Insulin Dose Prediction Model

ClinConnect Summary

This clinical trial is studying a new way to help manage insulin doses for people with type 2 diabetes who are hospitalized and using an insulin pump. Researchers are testing whether an artificial intelligence (AI) program can predict the right amount of insulin better or at least as well as doctors using their experience. The goal is to see if this AI tool can safely and effectively control blood sugar levels during the hospital stay.

People who might join this study are adults with type 2 diabetes who are already using an insulin pump while in the hospital for at least 6 days but less than 30 days. Participants will be randomly placed into two groups: one where the insulin dose is decided by the AI program, and another where doctors make the decision based on their experience. All participants will have their blood sugar levels continuously monitored and receive education on managing their diabetes, including advice on diet and exercise. This study is currently looking for volunteers who meet these criteria and do not have other serious health issues that could affect the treatment.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Meets the diagnostic criteria of type 2 diabetes mellitus in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition).
  • 2. Insulin pump is used to control blood glucose during hospitalization, and the duration of CSII treatment period ≥6 days and \<30 days.
  • Exclusion Criteria:
  • 1. Diabetes other than type 2.
  • 2. Age ≥75 years who is not suitable for intensive insulin therapy.
  • 3. Hypoglycemic regimen other than CSII treatment, such as oral hypoglycemic drugs or multiple daily insulin injections during hospitalization.
  • 4. 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.
  • 5. 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.
  • 6. Pregnancy.

About Sun Yat Sen University

Sun Yat-sen University, a prestigious institution located in Guangzhou, China, is dedicated to advancing medical research and healthcare innovations. As a leading clinical trial sponsor, the university leverages its extensive academic resources and collaboration with top-tier medical professionals to conduct rigorous clinical studies. Committed to improving patient outcomes and contributing to global health knowledge, Sun Yat-sen University focuses on a wide range of therapeutic areas, employing cutting-edge methodologies to ensure the integrity and efficacy of its research initiatives. Through its clinical trials, the university aims to foster scientific advancements and enhance the quality of care provided to patients both locally and internationally.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

Yanbing LI, MD.&Ph.D

Study Chair

First Affiliated Hospital of Sun yat-sen U

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported