Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Birth weight at time of Delivery
研究概览
简要总结
The purpose of this study is to assess whether an AI based counseling service can be beneficial for patients to assist in management of gestational diabetes.
详细描述
Gestational diabetes mellitus (GDM) affects approximately 6-9% of pregnancies globally, posing significant risks to both maternal and neonatal health. Standard management includes dietary counseling, glucose monitoring, and insulin therapy when necessary. However, the rising prevalence of GDM and limited healthcare resources necessitate innovative solutions to supplement traditional care. Generative Pre-trained Transformers (GPTs), a type of large language model (LLM), offer personalized, real-time counseling and support. Recent advancements in AI have shown promise in various healthcare applications, but the efficacy of GPT-based counseling in GDM management remains underexplored. This study builds on preliminary evidence suggesting that AI can enhance patient engagement and outcomes, aiming to validate these findings in a controlled trial.
The integration of AI, specifically GPTs, into healthcare can revolutionize patient management by providing continuous, tailored support. This study aims to evaluate whether GPT-based counseling can improve glycemic control and patient satisfaction in GDM management, compared to traditional counseling alone. By placing AI within the context of prenatal care, this research seeks to address gaps in current GDM management practices and offer scalable, personalized solutions.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-45
- •Diagnosed with GDM in pregnancy
- •Able to use a smartphone
- •Fluent in English or Spanish
排除标准
- •Pre-existing diabetes
- •High-risk pregnancies due to other medical conditions
- •Inability to consent
- •Non-English and/or Non-Spanish speakers
- •No smartphone access
研究组 & 干预措施
Nutritional Counseling plus AI Intervention
干预措施: GPT-based counseling (Device)
Nutritional Counseling plus AI Intervention
干预措施: Nutritional Counseling (Other)
Nutritional Counseling
干预措施: Nutritional Counseling (Other)
结局指标
主要结局
Birth weight at time of Delivery
时间窗: Within 12 hours of delivery
Newborns will be weighed within 12 hours of the time of delivery. Birth weights will be summarized and reported by study group using basic descriptive statistics. Higher birth weights have been associated with Gestational Diabetes Mellitus (GDM) and increased risk of perinatal complications.
次要结局
- Rate of Progression to medication requirements(At the time of delivery)
- Rate of Shoulder Dystocia(Within 12 hours of delivery)
- Rate of Neonatal Intensive Care Unit (NICU) admissions(Within 12 hours of delivery)
- Rate of Cesarean Section(Within 12 hours of delivery)
