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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Procedure: acute hypoxia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm<br>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. | Procedure: acute hypoxia<br>* Participants will be exposed to a 3-hour acute hypoxia<br>|
| Active Comparator: group 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm<br>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. | Procedure: acute hypoxia<br>* Participants will be exposed to a 3-hour acute hypoxia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Mean absolute relative difference (MARD) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of acute hypoxia | Arterial blood oxygen saturation (Sp02) | Day 1 | 
| Tolerability of acute hypoxia | Lake Louise Questionnaire | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM (Continuous Glucose Monitoring)