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FreeStyle Libre Glucose Monitoring System in Pediatric Populations

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03502174
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Brief Summary:
This study is a non-randomized, single-arm, multi-center study that is designed to evaluate the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in pediatric populations.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: FreeStyle Libre Flash Glucose Monitoring System

Detailed Description:
Up to 85 subjects will be enrolled at up to four (4) 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. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). 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 four (4) to five (5) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects weight, subjects will have up to two (2) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : July 3, 2018
Actual Study Completion Date : July 3, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose


Intervention Details:
  • Device: FreeStyle Libre Flash Glucose Monitoring System
    Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.


Primary Outcome Measures :
  1. FreeStyle Libre Flash Glucose Monitoring System Performance [ Time Frame: up to 14 days ]
    System performance will be characterized with respect to YSI reference venous plasma sample measurements. Point accuracy of the system will be evaluated as the proportion of System readings that are within ±20% of the YSI reference value for YSI glucose levels ≥ 80 mg/dl and within ±20 mg/dl for YSI glucose levels <80 mg/dl.

  2. FreeStyle Libre Flash Glucose Monitoring System Related adverse device effects [ Time Frame: up to 45 days ]
    System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects aged 6-17 years, with type 1 or type 2 diabetes who currently perform capillary blood glucose (BG) testing at least four (4) times a day.
Criteria
  • Inclusion Criteria:

    • Subject must be at least 6 years of age.
    • Subject must weigh at least 26 kg (57.2 lbs.).
    • Subject must have a diagnosis of type 1 or type 2 diabetes mellitus
    • Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
    • Subject must be currently performing at least four (4) capillary blood glucose tests per day.
    • Subject is willing to perform a minimum of 4 finger sticks per day during the study.
    • Subject is willing to allow medical personnel to insert at IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol.
    • Subject and/or guardian must be able to read and understand English.
    • 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.
    • Subject must be available to participate in all study visits.
    • Subject must be willing and able to provide written signed and dated informed assent when appropriate.
    • Subject's parent, guardian or legally authorized representative must be willing and able to provide written informed consent.
  • Exclusion Criteria:

    • Subject is 18 years of age or older.
    • Subject weighs less than 26 kg (57.2 lbs.).
    • Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
    • Subject is known to be pregnant or becomes pregnant during the study (applicable to female subjects only).
    • 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.
    • Subject is currently participating in another clinical trial.
    • Subject has had significant blood loss within 112 days (3.7 months) prior to the beginning of the study activities subjects.
    • Subject is anemic, defined as having hemoglobin levels below 11.5 g/dL for subjects aged 6-11 years old, less than 12.0 g/dL for subjects aged 12-15 years old, less than 12.0 g/dL for females aged 15-17 and less than 13.0 g/dL for males aged 15-171, or as determined by investigator.
    • Subject has X-ray, MRI or CT 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.
    • 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): NCT03502174


Locations
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United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Idaho
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Study Director: Shridhara Alva, PhD Abbot Diabetes care inc.

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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT03502174     History of Changes
Other Study ID Numbers: ADC-US-VAL-18172
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases