Evaluation of the Everyday Relevance of Reactive Hypoglycemia in the Oral Glucose Tolerance Test Using Continuous Glucose Measurement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Occurrence of hypoglycemia
研究概览
简要总结
This research project aims to investigate the everyday relevance of reactive hypoglycemia (hypoglycemia after a glucose load) in the oral glucose tolerance test (OGTT). Therefore, blood glucose profiles in everyday life will be examined using continuous glucose measurement (Free Style Libre PRO IQ system) over a period of 14 days in affected persons.
详细描述
The aim of this analysis is to examine people who underwent an OGTT due to various endocrinological and metabolic issues and developed reactive hypoglycemia, defined as a drop in blood glucose <70mg/dl during the course of the test. During OGTT routine laboratory testing will be performed as part of routine clinical practice. In order to investigate the occurrence and perception of hypoglycaemia in the everyday lives of those affected, their blood glucose profiles will be recorded and evaluated over a period of 14 days.
In addition, the perception of (suspected) hypoglycemia and counteraction will be documented. Anthropometric data will be recorded and a bioelectrical impedance analysis performed to check a correlation with the body composition. Subjects will be recruited via the endocrinology outpatient clinic as part of medical care. To date, very little CGM data are available on the frequency and extent of reactive hypoglycemia in the everyday lives of people without diabetes mellitus. Therefore, 20 subjects with hypoglycemia in the OGTT will be included in this exploratory pilot study for hypothesis generation in order to investigate the occurrence and perception of hypoglycemia in everyday life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Every participant receives a Freestyle Libre PRO IQ Sensor, a system which ensures blinding of the glucose levels to the participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •hypoglycemia during a 75 g oral glucose tolerance test defined as glucose level below 70 mg/dl at timepoint 180 min.
- •written consent
排除标准
- •diabetes mellitus
- •use of medication interfering with glucose metabolism (steroid, antidiabetic medications)
- •surgery of upper GI-tract
- •known plaster allergies
- •any other clinical condition that would endanger participants safety or question scientific success according to the physicians opinion
研究组 & 干预措施
CGM Group
Every participant receives a Free Style Libre Pro IQ sensor for 14 days. Glucose levels will be recorded. In addition perception of hypoglycemia and counter action will be assessed.
干预措施: Free Style Libre Pro IQ (Device)
结局指标
主要结局
Occurrence of hypoglycemia
时间窗: 14 days
Occurrence of glucose levels below 70 mg/dl assessed by CGM.
Frequency of hypoglycemia
时间窗: 14 days
Number of glucose levels below 70 mg/dl assessed by CGM.
Severity of hypoglycemia
时间窗: 14 days
Non-severe hypoglycemia defined as glucose levels \< 70 mg/dl but \>= 54mg/dl; severe hypoglycemia defined as glucose levels \< 54mg/dl assessed by CGM.
次要结局
- Perception of hypoglycemia(14 days)
- Mean glucose levels(14 days)
- Time of occurence of hypoglycemia(14 days)
- Time in predefined glucose ranges(14 days)
- Correlation between severity of hypoglycemia during ogtt and hypoglycemia in everyday life(Varying time point between oGTT and 14 days of glucose assessment using CGM)
- Glucose variability(14 days)
- Correlation between body composition and hypoglycemia in everyday life(14 days)
研究者
Martin Heni
Prof. Martin Heni
University of Ulm