AI-assisted insulin management for type 2 diabetes patients in hospitals
Efficacy and Safety of the Artificial Intelligence-assisted Insulin Dose Adjustment System for Glycaemic Control in Patients With Type 2 Diabetes Mellitus in General Wards: a Multicentre, Single-blind, Randomised Controlled Study
This study is testing whether using an AI system to manage insulin can help hospitalized patients with type 2 diabetes have better blood sugar control compared to traditional methods led by doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06319300 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an artificial intelligence-assisted insulin dosimetry system compared to traditional physician-led insulin adjustments for patients with type 2 diabetes admitted to general wards. A total of 140 patients will be randomly assigned to either the AI-assisted group or the physician-led group to assess glycaemic control and safety outcomes. The study aims to determine if AI can improve insulin dosing accuracy and patient outcomes during hospitalization. The trial is single-blind and multicentre, ensuring a robust comparison of the two approaches.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of type 2 diabetes for more than three months, requiring insulin therapy during a hospital stay.
Not a fit: Patients with type 1 diabetes, severe complications, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood glucose control and reduced risk of complications for hospitalized patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using AI for diabetes management, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus \> 3 months * Age≥18 years old * Receiving glucose-lowering therapy for at least 90 days * Blood glucose:7.8-22.2 mmol/L * Length of proposed hospitalisation ≥5 days Exclusion Criteria: * Type 1 diabetes mellitus, other special types of diabetes mellitus. * BG\>22.2 mmol/L, or acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar state. * History of severe or repeated hypoglycaemia * BMI≥45 kg/m2 * Pregnant and lactating women * Clinically relevant liver disease (established cirrhosis and portal hypertension); * Presence of severe renal disease (serum creatinine ≥3.0 mg/dL or estimated glomerular filtration rate \<30 ml/min/1.73 m2); * Severe cardiac insufficiency; * Patients on cortisol-based hormone therapy (equivalent to a prednisone dose \>5 mg/day); * Psychiatric abnormalities or impaired cognitive function; * Patients with severe oedema, infection, or peripheral blood circulation disorder; * Patients with severe illness or patients to be transferred to ICU for treatment; * Surgery of the heart or abdomen that may have a significant impact on the test is planned during hospitalisation.
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.