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

Primary Purpose

Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
acute hypoxia
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes Mellitus focused on measuring CGM (Continuous Glucose Monitoring)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Safety of acute hypoxia
Arterial blood oxygen saturation (Sp02)
Tolerability of acute hypoxia
Lake Louise Questionnaire

Full Information

First Posted
October 29, 2021
Last Updated
May 25, 2022
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05144802
Brief Title
Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
Official Title
Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Keywords
CGM (Continuous Glucose Monitoring)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1 : FreeStyle Libre 2 on right arm and Dexcom G6 on left arm
Arm Type
Experimental
Arm Description
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.
Arm Title
group 2 : 2 FreeStyle Libre 2 on left arm and Dexcom G6 on right arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
acute hypoxia
Intervention Description
Participants will be exposed to a 3-hour acute hypoxia
Primary Outcome Measure Information:
Title
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.
Description
Mean absolute relative difference (MARD)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Safety of acute hypoxia
Description
Arterial blood oxygen saturation (Sp02)
Time Frame
Day 1
Title
Tolerability of acute hypoxia
Description
Lake Louise Questionnaire
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BONNIN Marie
Phone
+33(0)5 49 44 33 17
Email
marie.bonnin@chu-poitiers.fr
Facility Information:
Facility Name
CHU
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SAULNIER Pierre-Jean, MD PhD

12. IPD Sharing Statement

Learn more about this trial

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

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