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Completed
NCT05144802
Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
Conditions: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Poitiers University Hospital
Location: CHU Poitiers
Summary
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.
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\ 60 mm Hg)
* Presence of intra-cardiac thrombus
* Acute pericardial effusion
* Severe obstructive cardiomyopathy
* Symptomatic aortic stenosis
* Recent thrombophlebitis with or without pulmonary embolism
Source: ClinicalTrials.gov (NCT05144802). StuddyBuddy aggregates publicly available trial information.