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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acute hypoxia | Procedure | Participants will be exposed to a 3-hour acute hypoxia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria: all population
Inclusion Criteria:Patients with diabetes
Inclusion Criteria: Healthy volunteers
Non-inclusion criteria : all population
Non-inclusion criteria: Patients with diabetes
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Poitiers | 86000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41703423 | Result | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Freestyle-CGM on the right arm and Dexcom-CGM on the left arm were placed for healthy volontueers and participants with diabetes |
| FG001 | Group 2 | Freestyle-CGM on the letf arm and Dexcom-CGM on the right arm were placed for healthy volontueers and participants with diabetes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | group in which participants had no health problems |
| BG001 | Participants With Diabetes | Group of participants with diabetes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | percent | Day 1 |
|
During the 3-hour hypoxia exposure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | group in which participants had no health problems | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pierre Jean Saulnier | CHU Poitiers | +33 5 49 44 46 89 | pierre.jean.saulnier@univ-poitiers.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2023 | Feb 9, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Glycated hemoglobin | Median | Inter-Quartile Range | Percent |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Participants With Diabetes | Group of participants with diabetes | 0 | 15 | 0 | 15 | 0 | 15 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |