Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
About this trial
This is an interventional basic science trial for Type 1 Diabetes Mellitus focused on measuring CGM (Continuous Glucose Monitoring)
Eligibility Criteria
Inclusion Criteria: 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
Sites / Locations
- CHURecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm
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 : FreeStyle Libre 2 will be applied on right arm and Dexcom G6 will be applied on left 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.