Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions

Poitiers University Hospital

Status: Completed

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Procedure: acute hypoxia

Study type: Interventional

Funder types: Other

Identifiers

NCT05144802

FOX

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm

Experimental group

Description:

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.

Treatment:

Procedure: acute hypoxia

group 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm

Active Comparator group

Description:

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.

Treatment:

Procedure: acute hypoxia