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OpenTrials
Completed

NCT Number: NCT05144802

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acute hypoxia

Procedure

Participants will be exposed to a 3-hour acute hypoxia

Primary outcomes

  1. Mean Absolute Relative Difference (MARD)

    Time frame: Day 1

    The primary endpoint for measuring the accuracy of CGMs (individually) compared to venous blood glucose was the mean absolute relative difference, expressed as a percentage. As the percentages obtained did not follow a normal distribution, they are expressed in the table as median and IQR.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2021
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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