NCT06319300Completed
Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards
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
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to enrol 142 patients with T2DM admitted to general wards who required subcutaneous insulin therapy. Participants were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence-assisted insulin decision system to adjust insulin doses for blood glucose control, and the other group received clinician-instituted insulin dose adjustments for blood glucose control. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 144 (actual)
- First submitted
- 13 Mar 2024
- Start date
- 19 Apr 2024
- Primary completion date
- 20 Sept 2025
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06319300
What you commit to
- Study type: Interventional
- Participants enrolled: 144
- From 19 Apr 2024 to the primary completion date, 20 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing corticosteroid therapy (equivalent to a prednisone dose \>5 mg/day)
Other illness
- Type 1 diabetes mellitus, other special types of diabetes mellitus
- History of severe or repeated hypoglycaemia
- Clinically relevant liver disease (established cirrhosis and portal hypertension)
- Severe cardiac insufficiency
- 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
- Any medical or psychological conditions, or medications that, in the doctor's judgment, could interfere with the results
Lab values
- BG\>22.2 mmol/L, or acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar state
- Presence of severe renal disease (serum creatinine ≥3.0 mg/dL or estimated glomerular filtration rate \<30 ml/min/1.73 m2)
Other
- BMI≥45 kg/m2
- Pregnant and lactating women
- Expected to be NPO for an extended period
- Subjects who cannot comply with the protocol.
Who the study is looking for
- Diagnosis of type 2 diabetes mellitus \> 3 months
- Age≥18 years old
- Receiving glucose-lowering management for at least 90 days
- Blood glucose:7.8-22.2 mmol/L
- Length of proposed hospitalisation ≥5 days.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.