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

Last updated: April 7, 2025
Sponsor: Poitiers University Hospital
Overall Status: Completed

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Hypertriglyceridemia

Treatment

acute hypoxia

Clinical Study ID

NCT05144802
FOX
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: acute hypoxia
Phase:
Study Start date:
May 16, 2022
Estimated Completion Date:
January 28, 2025

Connect with a study center

  • CHU

    Poitiers, 86000
    France

    Site Not Available

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