Clinical trial NCT05144802: Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
Official title: Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: CGM (Continuous Glucose Monitoring)
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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\<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

Primary outcomes:
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: Safety of acute hypoxia
timeFrame: Day 1
measure: Tolerability of acute hypoxia
timeFrame: Day 1
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU
Study officials:
References: