FreeStyle Libre 3 Continuous Glucose Monitoring System

Last updated: July 19, 2023
Sponsor: Abbott Diabetes Care
Overall Status: Terminated

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

FreeStyle Libre 3

Clinical Study ID

NCT05962710
ADC-US-VAL-22221
  • Ages > 2
  • All Genders

Study Summary

The purpose of this study is to characterize the FreeStyle Libre 3 Continuous Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must be at least 2 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 dailyinsulin injections or inhalations (at least 3 daily).
  4. Subject must be able to read and understand English.
  5. In the investigator's opinion, the subject must be able to follow the instructionsprovided to him/her by the study site and perform all study tasks as specified by theprotocol.
  6. At the time of enrollment, subject must be available to participate in all studyvisits.
  7. For subjects age 2 to 5: willing to allow medical personnel to perform up to 16capillary fingersticks to allow for capillary blood samples to be obtained per thestudy protocol.
  8. For subjects age 6 and older: willing to allow medical personnel to insert an IVcatheter in the arm to allow for venous blood samples to be obtained per the studyprotocol.
  9. Subjects aged 18 years and older must be willing and able to provide written signedand dated informed consent.
  10. Subjects aged 17 years and younger must have a parent, guardian or legally authorizedrepresentative willing and able to provide written informed consent.
  11. Subjects aged 7 - 17 years must be willing and able to provide written signed anddated informed assent.

Exclusion

Exclusion Criteria: 12. Subjects age 18 and older: Subject is known to be pregnant, attempting to conceive oris not willing and able to practice birth control during the study duration (applicable to only to female subjects age 18 and older). 13. Subjects age 17 and younger: Subject is known to be pregnant or becomes pregnantduring the study (only applicable to female subjects age 17 years and younger) 14. Subject has known allergy to medical grade adhesive or isopropyl alcohol used todisinfect skin. 15. Subject has extensive skin changes/diseases at the proposed application sites thatcould interfere with device placement or the accuracy of interstitial glucosemeasurements. Such conditions include, but are not limited to extensive psoriasis,recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitisherpetiformis, skin lesions, redness, infection or edema. 16. Subject is currently participating in another clinical trial. 17. Subject has donated blood within 60 days prior to the beginning of the studyactivities. 18. For subjects aged 6 years and older: subject has a hemoglobin (Hb) level that is 10%or more below the normal range (for reference the low end of the normal range for Hbfor adult males is 12.6 g/dL and for adult females is 11.7 g/dL1; for pediatric malesand pediatric females aged 6 - 9 years it is 11.5 g/dL1; for pediatric males andpediatric females aged 10 - 12 it is 12.0 g/dL1; for ; for pediatric males aged 13 - 14 it is 12.0 g/dL and pediatric females aged 13 - 14 it is 11.5 g/dL1; and forpediatric males and pediatric females aged 15 - 17 it is 11.7 g/dL1) 19. Subject has a known concomitant medical condition which, in the opinion of theinvestigator, could present a risk to the safety or welfare of the subject or studystaff. 20. Subject has X-ray, MRI, CT or diathermy appointment scheduled during the period ofstudy participation, and the appointment cannot be rescheduled for a time before studyparticipation starts or after study participation ends. 21. Subject is unsuitable for participation due to any other cause as determined by theinvestigator.

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: FreeStyle Libre 3
Phase:
Study Start date:
January 27, 2023
Estimated Completion Date:
January 31, 2023

Study Description

This is a pivotal, non-randomized, single arm, multi-center, prospective, nonsignificant risk study to evaluate the FreeStyle Libre 3 Continuous Glucose Monitoring System accuracy and safety. Up to 80 adult subjects (18 years of age or older) and up to 80 pediatric subjects (2-17 years of age) subjects will be enrolled at up to six (6) clinical research sites in the United States. Each subject will wear two sensors for 15 days.

Interstitial glucose readings from each Sensor will be obtained with a corresponding smart phone. Subjects will do 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.

Connect with a study center

  • Sansum Diabetes Research Institute

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Rocky Mountain Diabetes & Osteoporosis Center

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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