Clinical Validation of AI-assisted Antidiabetic Drug Consultation System-1
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline to 12 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in HbA1c from baseline to 12 months
时间窗: Baseline and 12 months
The between-group difference in the change in glycated hemoglobin (HbA1c) from baseline to 12 months, comparing the AI-assisted prescribing arm with the manual prescribing (control) arm. HbA1c reflects long-term glycemic control. The primary analysis uses analysis of covariance (ANCOVA) adjusting for baseline HbA1c, following the intention-to-treat principle.
次要结局
- Proportion of participants achieving HbA1c < 7.0% at 12 months(12 months)
- Incidence of hypoglycemia over 12 months(Up to 12 months)
- Incidence of prespecified adverse events over 12 months(Up to 12 months)
- Change in HbA1c from baseline at 3, 6, 9, and 12 months(Baseline, 3, 6, 9, and 12 months)