Evaluation of the Profile of Blood Glucose Using Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- The percentage of time with low CGM values ( blood glucose <4.0 mmol/l)
研究概览
简要总结
The purpose of this study was to obtain reference values of CGM in healthy individuals using the Dexcom G4 sensor and evaluate whether reported low glucose values by the Dexcom G4 sensor are really low when confirmed by capillary testing.
详细描述
Evaluation of the profile of blood glucose using Dexcom G4 in a population with normal oral glucose tolerance test. The investigators have used information from a previous study of 60 participants using Dexcom G4, CGM system. A non-randomized, days 1-7 blinded and days 8-14 non-blinded CGM trial, the study was performed to evaluate the profile of blood glucose using CGM in the population with normal oral glucose tolerance test (OGTT). All enrolled subjects with at least three time-points with evaluable values from CGM system and the reference capillary value obtained from HemoCue during the whole study period were included in the Intent-to-Treat (ITT) population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Normal oral glucose tolerance test
- •Normal HbA1c value
- •Age of 18 years or older
排除标准
- •Known diabetes
- •Known prediabetes
- •Corticosteroid use during the last month
- •Planned corticosteroid use during the study
- •Pregnancy or planned pregnancy during the study period
- •Paracetamol use during the last 2 days
- •Planned paracetamol use during the study
- •Allergy to any adhesives used for CGM or clorhexidine
研究组 & 干预措施
CGM in a population with normal OGTT
A non-randomized, days 1-7 blinded, and days 8-14 non-blinded Dexcom G4 (CGM) trial. Each subject will sample capillary blood with the HemoCue meter and measure the concentration of glucose, minimum 3 times per day for 14 days.
干预措施: CGM in a population with normal OGTT (Other)
结局指标
主要结局
The percentage of time with low CGM values ( blood glucose <4.0 mmol/l)
时间窗: Day 1-7
Percentage of time with low CGM values, Measured by continuous glucose monitoring (CGM) (\<72 mg/dL, \<4.0 mmol/L) estimated on days 1-7 when participants used masked CGM.
次要结局
- Mean Absolute Difference (MAD)(Day 1-7, Day 8-14)
- Coefficient of Variation (CV)(Day 1-7, Day 8-14)
- The percentage of time with glucose levels in euglycaemic range (72-180 mg/dL)(Day 1-14)
- Difference in Mean Amplitude of Glycemic Excursions (MAGE)(Day 1-7, Day 8-14)
- The percentage of time with glucose levels in hyperglycaemic range (>198 mg/dL)(Day 1-14)
- The percentage of time with glucose levels in hyperglycaemic range (>252 mg/dL)(Day 1-14)
- The percentage of time with low CGM values (blood glucose <3.0 mmol/l)(Day 1-7)
- The difference in mean glucose levels between days 1-7 and day 8-14(Day 1-7 and day 8-14)
- The percentage of time with glucose levels in euglycaemic range (72-126 mg/dL)(Day 1-14)
- The Standard Deviation (SD)(Day 1-7 and day 8-14)
- The evaluation of experience of the CGM, glucose monitoring systems.(Week 2, day14)
- Mean Absolute Relative Difference (MARD)(Day 1-14)
- Pearson correlation coefficient(Day 8-14)