Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions (NCT05144802) | Clinical Trial Compass
CompletedNot Applicable
Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
France30 participantsStarted 2022-05-16
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tested whether the Dexcom G6 and FreeStyle Libre sensors give accurate readings during low-oxygen conditions — what does that mean for how reliable my CGM readings are if I ever experience low blood oxygen, such as during illness or at high altitude?
2The trial measured something called Mean Absolute Relative Difference to compare sensor accuracy — can you explain what that tells us about how much my CGM reading might be off from my actual blood sugar in certain conditions?
3Since this study is now completed, are there published results I should know about, and do those findings change your recommendation about which CGM sensor is better suited for me?
4If either sensor was found to be less accurate under low-oxygen conditions, should I be taking any extra precautions — like doing more fingerstick checks — in situations where my oxygen levels might drop?
5Given that this was a study focused on accuracy rather than a treatment trial, is there anything about my specific health situation, like heart or lung conditions, that would make CGM accuracy under low-oxygen conditions especially important for me to discuss?'
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.