NCT05144802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2025

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2.7 years

First QC Date

October 29, 2021

Results QC Date

February 9, 2026

Last Update Submit

June 16, 2026

Conditions

Type 1 Diabetes MellitusType 2 Diabetes Mellitus

Keywords

CGM (Continuous Glucose Monitoring)

Outcome Measures

Primary Outcomes (1)

  • Mean Absolute Relative Difference (MARD)

    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.

    Day 1

Study Arms (2)

group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm

EXPERIMENTAL

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.

Procedure: acute hypoxia

group 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm

ACTIVE COMPARATOR

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.

Procedure: acute hypoxia

Interventions

acute hypoxiaPROCEDURE

Participants will be exposed to a 3-hour acute hypoxia

group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left armgroup 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.
  • Age : 18 ; 40 years
  • No diabetes
  • No persistant drug use \> 3 months except contraception
  • Body mass index : \[18,5 - 29,9\] kg/m2
  • Active smokers
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Poitiers, 86000, France

Location

Related Publications (1)

  • Bassas Letissier N, Rault C, Faucher C, Rabois E, Durocher L, Bouleti C, Ragot S, Hadjadj S, Mosbah H, Piguel X, Alos B, Thuillier R, Saulnier PJ. Accuracy of Dexcom G6(R) and FreeStyle Libre(R) Sensors in Standardized Hypoxia Conditions: A Randomized Controlled Trial-FOX Study. Diabetes Technol Ther. 2026 Feb 17:15209156261423954. doi: 10.1177/15209156261423954. Online ahead of print.

    PMID: 41703423RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Pierre Jean Saulnier
Organization
CHU Poitiers
pierre.jean.saulnier@univ-poitiers.fr
+33 5 49 44 46 89

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

December 3, 2021

Study Start

May 16, 2022

Primary Completion

January 28, 2025

Study Completion

January 28, 2025

Last Updated

June 17, 2026

Results First Posted

June 17, 2026

Record last verified: 2026-06

Locations

FR(1)