Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards (NCT06319300) | Clinical Trial Compass
CompletedNot Applicable
Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards
China144 participantsStarted 2024-04-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
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 undergoing corticosteroid 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
* Expected to be NPO for an extended period
* Any medical or psychological conditions, or medications that, in the doctor's judgment, could interfere with the results
* Subjects who cannot comply with the protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.