Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Keywords
CGM (Continuous Glucose Monitoring)
Brief 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.
Interventions
PROCEDUREacute hypoxia
Participants will be exposed to a 3-hour acute hypoxia
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Relative Difference (MARD) | 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. |
Countries
France
Participant flow
Recruitment details
Recruitment period: May 2022 to November 2024 at CHU de Poitiers. Healthy volunteers were recruited from the Clinical Investigation Center (CIC) volunteer registry. Participants with diabetes were identified and referred by general practionner and endocrinologists from the hospital.
Pre-assignment details
Two severe adverse events were recorded (one road traffic accident and one domestic accident). Both occurred before randomization, preventing one of the participants from being randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.5 years |
| Glycated hemoglobin | 7.5 Percent |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
None listed