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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05144802
• Other study ID #: FOX
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: May 2022
• Source: Poitiers University Hospital
• Contact: BONNIN Marie
• Phone: +33(0)5 49 44 33 17
• Email: marie.bonnin[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Hypoxia
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• acute hypoxia
Participants will be exposed to a 3-hour acute hypoxia

Locations

Country	Name	City	State
France	CHU	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Mean absolute relative difference (MARD)	Day 1
Secondary	Safety of acute hypoxia	Arterial blood oxygen saturation (Sp02)	Day 1
Secondary	Tolerability of acute hypoxia	Lake Louise Questionnaire	Day 1