Trial Outcomes & Findings for Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions (NCT NCT05144802)
NCT ID: NCT05144802
Last Updated: 2026-06-17
Results Overview
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.
COMPLETED
NA
30 participants
Day 1
2026-06-17
Participant Flow
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.
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.
Participant milestones
| Measure |
Group 1
Freestyle-CGM on the right arm and Dexcom-CGM on the left arm were placed for healthy volontueers and participants with diabetes
|
Group 2
Freestyle-CGM on the letf arm and Dexcom-CGM on the right arm were placed for healthy volontueers and participants with diabetes
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=15 Participants
group in which participants had no health problems
|
Participants With Diabetes
n=15 Participants
Group of participants with diabetes
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
n=15 Participants
|
41 years
n=15 Participants
|
29.5 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
14 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
16 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Glycated hemoglobin
|
5.2 Percent
n=15 Participants
|
7.5 Percent
n=15 Participants
|
5.8 Percent
n=30 Participants
|
PRIMARY outcome
Timeframe: Day 1The 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.
Outcome measures
| Measure |
Healthy Volunteers
n=15 Participants
group in which participants had no health problems
|
Participants With Diabetes
n=15 Participants
Group of participants with diabetes
|
|---|---|---|
|
Mean Absolute Relative Difference (MARD)
Freestyle CGM
|
21.2 percent
Interval 16.6 to 37.9
|
11.8 percent
Interval 6.5 to 17.6
|
|
Mean Absolute Relative Difference (MARD)
Dexcom CGM
|
41.8 percent
Interval 26.9 to 69.7
|
17.5 percent
Interval 14.3 to 23.5
|
Adverse Events
Healthy Volunteers
Participants With Diabetes
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place