Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
NCT ID: NCT05144802
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-05-16
2025-01-28
Brief Summary
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Our purpose is to demonstrate the good performance and calibration of these CGM sensors in hypoxemia conditions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
acute hypoxia
Participants will be exposed to a 3-hour acute hypoxia
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.
acute hypoxia
Participants will be exposed to a 3-hour acute hypoxia
Interventions
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acute hypoxia
Participants will be exposed to a 3-hour acute hypoxia
Eligibility Criteria
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Inclusion Criteria
* Willing to participate and able to sign an informed consent form (ICF)
* Being affiliated with the French Social Security
* 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.
* Age : 18 ; 40 years
* No diabetes
* No persistant drug use \> 3 months except contraception
* Body mass index : \[18,5 - 29,9\] kg/m2
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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CHU
Poitiers, , France
Countries
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Other Identifiers
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FOX
Identifier Type: -
Identifier Source: org_study_id
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