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FreeStyle Libre 3 Continuous Glucose Monitoring System Accuracy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464772
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Brief Summary:
The purpose of this study is to characterize the Freestyle Libre 3 Glucose Monitoring System in pediatric and adult subjects with respect to YSI reference venous plasma sample measurements.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: FreeStyle Libre 3

Detailed Description:

Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be given to the subject. Subjects will be asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary Reader.

Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make up to six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age and

/or weight, subjects will have up to three (3) in- clinic visits during which intravenous blood draws and YSI reference testing will occur.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Libre 3 Continuous Glucose Monitoring System Accuracy Study
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • Device: FreeStyle Libre 3
    FreeStyle Libre 3 Continuous Glucose Monitoring System


Primary Outcome Measures :
  1. System Performance [ Time Frame: 45 days ]
    System Performance will be characterized with respect to YSI reference venous plasma measurements



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).
Criteria

Inclusion Criteria:

  1. Subject must be at least 4 years of age.
  2. Subject must have type 1 or type 2 diabetes.
  3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
  4. Willing to perform a minimum of 4 finger sticks per day while wearing the sensor in the study.
  5. Subject must be able to read and understand English.
  6. For subjects age 6 and older: willing to allow medical personnel to insert an IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol.
  7. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
  8. At the time of enrollment, subject must be available to participate in all study visits.
  9. Subjects aged 18 years and older must be willing and able to provide written signed and dated informed consent.
  10. Subjects aged 17 years and younger must have a parent, guardian or legally authorized representative willing and able to provide written informed consent.
  11. Subjects aged 7 - 17 years of age must be willing and able to provide written signed and dated informed assent.

Exclusion Criteria:

  1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  2. Subjects age 18 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to only to female subjects age 18 and older).
  3. Subjects age 17 and younger: Subject is known to be pregnant or becomes pregnant during the study (only applicable to female subjects age 17 years and younger)
  4. Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
  5. Subject is currently participating in another clinical trial.
  6. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
  7. For subjects age 6 and older: subject has a hemoglobin (Hb) level that is below the normal range (for reference the low end of the normal range for Hb for adult males is 14 g/dL and for adult females is 12 g/dL; for pediatric males and pediatric 13.0 g/dL; for pediatric females aged 12 - 17 it is 12.0 g/dL2).
  8. Subject has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
  9. Subject has X-ray, MRI, CT or diathermy appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
  10. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464772


Contacts
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Contact: Mohamed Nada, PhD 510-749-5416 ADC.Clinical@abbott.com

Locations
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United States, California
AMCR Institute
Escondido, California, United States, 92026
Contact: Timothy Bailey, MD         
Principal Investigator: Timothy Bailey, MD         
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Contact: Kristin Castorino, DO    805-682-7638      
United States, Idaho
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
Contact: David Liljenquist, MD         
Principal Investigator: David Liljenquist, MD         
United States, Washington
Rainier Clinical Research
Renton, Washington, United States, 98057
Contact: Ronald Brazg, M.D.         
Principal Investigator: Ronald Brazg, M.D.         
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Study Director: Shridhara A Karinka, PhD Abbott Diabetes Care
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT04464772    
Other Study ID Numbers: ADC-US-VAL-20192
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No