Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assess accuracy of interstitial glucose values measured respectively by FreeStyle® Libre and Dexcom® G6 compared to blood glucose values in standardized hypoxemia conditions in patients with diabetes and in healthy volunteers.
研究概览
简要总结
The major aim is to evaluate accuracy of 2 Continuous Glucose Monitoring Systems (CGMS) : Dexcom G6® and FreeStyle Libre® in standardized hypoxemia conditions (artificial normobaric hypoxia).
Our purpose is to demonstrate the good performance and calibration of these CGM sensors in hypoxemia conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all population
- •No history of respiratory diseases (childhood asthma, respiratory allergies, exercise-induced asthma or dyspnea)
- •Willing to participate and able to sign an informed consent form (ICF)
- •Being affiliated with the French Social Security
- •Inclusion Criteria:Patients with diabetes
- •type 1 diabetes mellitus or type 2 diabetes mellitus (ADA definition)
- •Age : 18 to 75 years
- •stable diabetes treatment for more than 3 months
- •no diabetic retinopathy
- •no diabetic neuropathy
- •no cardiovascular diseases
- •no contra-indication for coronary computed tomography angiography or myocardial perfusion scintigraphy.
- •Inclusion Criteria: Healthy volunteers
- •Age : 18 ; 40 years
- •No diabetes
- •No persistant drug use > 3 months except contraception
- •Body mass index : [18,5 - 29,9] kg/m2
- •Non-inclusion criteria : all population
- •Active smokers
- •Pregnant or breastfeeding women, women of childbearing age without effective contraception
- •Known allergies to the patch.
- •Skin lesions at the sensor site that may interfere with sensor placement or accuracy
- •Major cardiovascular complications within the past 3 months
- •Decompensated congestive heart failure
- •Chronic respiratory failure
- •Chronic renal failure
- •Resting ambient air O2 saturation ≤95%.
- •Treatment with systemic corticosteroids
- •Severe hypertension (≥180 mmHg systolic pressure or ≥ 100 mmHg diastolic pressure)
- •Any concomitant disease or condition that the investigator believes may compromise patient safety or affect the conduct of the study
- •Anemia (Hb<12g/dl)
- •History of severe mountain sickness
- •Concurrent participation in another clinical research study,
- •Persons benefiting from enhanced protection
- •Non-inclusion criteria: Patients with diabetes
- •Absolute contraindications to physical activity (HAS definitin) :
- •Pulmonary arterial hypertension (> 60 mm Hg)
- •Presence of intra-cardiac thrombus
- •Acute pericardial effusion
- •Severe obstructive cardiomyopathy
- •Symptomatic aortic stenosis
- •Recent thrombophlebitis with or without pulmonary embolism
排除标准
- 未提供
研究组 & 干预措施
group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm
In this group, participants will be continuously monitored for their interstitial glucose level with 2 CGM devices : FreeStyle Libre 2 will be applied on right arm and Dexcom G6 will be applied on left arm.
干预措施: acute hypoxia (Procedure)
group 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm
In this group, participants will be continuously monitored for their interstitial glucose level with 2 CGM devices : Dexcom G6 will be applied on right arm and FreeStyle Libre 2 will be applied on left arm.
干预措施: acute hypoxia (Procedure)
结局指标
主要结局
Assess accuracy of interstitial glucose values measured respectively by FreeStyle® Libre and Dexcom® G6 compared to blood glucose values in standardized hypoxemia conditions in patients with diabetes and in healthy volunteers.
时间窗: Day 1
Mean absolute relative difference (MARD)
次要结局
- Tolerability of acute hypoxia(Day 1)
- Safety of acute hypoxia(Day 1)