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Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards
Led by Shanghai Zhongshan Hospital · Updated on 2025-08-06
140
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
S
Shanghai Zhongshan Hospital
Lead Sponsor
S
Shanghai Fifth People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.
CONDITIONS
Official Title
Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 2 diabetes mellitus for more than 3 months
- Age 18 years or older
- Receiving glucose-lowering therapy for at least 90 days
- Blood glucose between 7.8 and 22.2 mmol/L
- Planned hospital stay of 5 days or more
You will not qualify if you...
- Type 1 diabetes mellitus or other special types of diabetes
- Blood glucose level above 22.2 mmol/L or acute diabetic complications such as ketoacidosis or hyperosmolar state
- History of severe or repeated low blood sugar
- Body mass index 45 kg/m2 or higher
- Pregnant or breastfeeding women
- Clinically relevant liver disease including cirrhosis and portal hypertension
- Severe kidney disease (serum creatinine 3.0 mg/dL or estimated glomerular filtration rate below 30 ml/min/1.73 m2)
- Severe heart failure
- Use of cortisol-based hormone therapy equivalent to prednisone over 5 mg/day
- Psychiatric disorders or impaired cognitive function
- Severe edema, infection, or blood circulation problems in limbs
- Severe illness or planned transfer to intensive care unit
- Planned heart or abdominal surgery during hospital stay that may affect the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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