NCT05668819已完成不适用
Open-Label, Randomized, Controlled, Parallel Group Study Evaluating Efficacy and Safety of Digital Therapeutic (TH-001) for the Treatment of Prediabetes in Adults
Tesu Saglik Teknolojileri A.S.2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2023年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with prediabetes according to the ADA Prediabetes Diagnostic Criteria (the presence of at least one of the following criteria is sufficient for diagnosis: FBG 100 - 125 mg/dL, OGTT 2 hour BG: 140 - 199 mg/dL, HbA1c: 5.7% - 6.4)
- •Not using medication for the treatment of prediabetes, and if so, taking a break for at least two weeks
- •Having a smartphone with an iOS or Android operating system
- •Being able to use a mobile application
排除标准
- •Being diagnosed with diabetes mellitus
- •Having a disease that can cause prediabetes
- •Taking medication that may cause prediabetes
结局指标
主要结局
Change in HbA1c
时间窗: 90 days
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
Change in PPG
时间窗: 90 days
The difference in the mean change from baseline in 2-hour 75 g OGTT (mg/dL) at Day 90 between groups.
Change in FPG
时间窗: 90 days
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
次要结局
- Change in BMI(90 days)
- Change in WC(90 days)
- Change in weight(90 days)
- Change in WHR(90 days)
研究者
研究点 (2)
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