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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
• Interventions: Procedure: acute hypoxia

• Registration Number: NCT05144802
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-03
• Study Start: 2022-05-16
• Primary Completion: 2025-01-28
• Study Completion: 2025-01-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm	acute hypoxia	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.
group 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm	acute hypoxia	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.

Primary Outcome Measures

Name	Time	Method
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.	Day 1	Mean absolute relative difference (MARD)

Secondary Outcome Measures

Name	Time	Method
Tolerability of acute hypoxia	Day 1	Lake Louise Questionnaire
Safety of acute hypoxia	Day 1	Arterial blood oxygen saturation (Sp02)

Trial Locations

Locations (1)

CHU; 🇫🇷 Poitiers, France