NCT05151770已完成不适用
Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm
M-DT12 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月30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
- 40
- 试验地点
- 2
- 主要终点
- Algorithm efficacy
研究概览
简要总结
The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Type 1 diabetes
- •≥ 18 years old
- •Hb1Ac<12%
排除标准
- •Patient without continuous glucose monitoring system
- •Disease other than diabetes (bulimia, anorexia...)
- •Dialysis patient
- •Known history of drug or alcohol abuse
- •Patient under judicial protection
- •Person deprived of liberty
- •Pregnant, parturient or breastfeeding woman
- •Patient in psychiatric care
- •Patient admitted to a health or social institution for purposes other than research
- •Any reasons that might interfere with the evaluation of the study objectives
结局指标
主要结局
Algorithm efficacy
时间窗: 15 days
The Algorithm efficacy in predicting the risk or absence of risk of hyperglycemia two hours after taking a full meal is evaluated by comparing glycemic values calculated by the algorithm and those obtained using continuous glucose monitoring system measurements.
次要结局
- Algorithm efficacy (lower margin of error)(15 days)
- Algorithm efficacy versus meal composition(15 days)
- Influence of the age of the patients on algorithm results(15 days)
- Influence of the BMI on algorithms results(15 days)
- Influence of the insulin administration on algorithm results(15 days)
研究者
研究点 (2)
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