Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06319300

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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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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