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Not Yet Recruiting NCT07684690

AI-Assisted Antidiabetic Drug Consultation System for Glycemic Control in Type 2 Diabetes Patients Managed by Non-Specialist Physicians

Conditions: Type 2 Diabetes Mellitus (T2DM)

Sex: All
Ages: 19 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: National Taiwan University Hospital

Location: National Taiwan University Hospital Taipei

Summary

This study tests whether an artificial intelligence (AI) tool can help doctors choose better diabetes medicines for their patients. Type 2 diabetes is very common, but there are far more patients than diabetes specialists, so many patients are treated by doctors who are not diabetes specialists. The researchers built an AI consultation system that gives doctors real-time suggestions and predictions about diabetes medicines while they are prescribing. The doctor always makes the final decision. In this trial, patients with type 2 diabetes whose blood sugar is not well controlled will be placed by chance (randomly) into one of two groups. In one group, the doctor uses the AI system when deciding on diabetes medicines. In the other group, the doctor prescribes as usual, without the AI system. All medicines used are already approved in Taiwan and given at approved doses. The study follows each patient for 12 months, with check-ups at the start and at 3, 6, 9, and 12 months. The main goal is to compare how much the patients' long-term blood sugar level (HbA1c) improves between the two groups after one year. The researchers also look at how many patients reach their blood sugar target, how often low blood sugar happens, and whether any side effects occur. The aim is to find out whether using the AI tool leads to better blood sugar control.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 to 80 years * Diagnosis of type 2 diabetes for at least 6 months * HbA1c above 8% within the past 3 months * Currently using one or more oral antidiabetic drugs * Able to understand and provide written informed consent Exclusion Criteria: * Pregnancy or breastfeeding * Recent participation in another interventional clinical trial * Cognitive impairment precluding understanding of the study * Active cancer treatment within the past 6 years * Use of systemic steroids

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07684690). StuddyBuddy aggregates publicly available trial information.