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FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study

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ClinicalTrials.gov Identifier: NCT03820050
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

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

Condition or disease Intervention/treatment
Diabetes Mellitus Device: Freestyle LIbre Flash Glucose Monitoring System

Detailed Description:
Up to 250 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. 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 three (3), four (4) or 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 : 144 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study
Actual Study Start Date : January 29, 2019
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose


Intervention Details:
  • Device: Freestyle LIbre Flash Glucose Monitoring System
    System Performance will be characterized with respect to YSI reference venous plasma measurements


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 to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric subjects aged 4-17 with Type 1 or Type 2 diabetes.
Criteria

Inclusion Criteria:

  • Subject must be between the ages of 4 and 17 years of age at the time of study enrollment.
  • Subject must have type 1 or type 2 diabetes.
  • Subjects age 11 and older must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
  • Willing to perform a minimum of 4 finger sticks per day while wearing the sensor in the study.
  • Subject and/or guardian must be able to read and understand English.
  • For subjects age 6 and older: willing to allow medical personnel to insert an IV catheter in the arm to allow for venous blood flow samples to be obtained per the study protocol.
  • For subjects age 11 and older: subject is willing to have their blood sugar manipulated during one or more in-clinic sessions.
  • 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.
  • At the time of enrollment, subject must be available to participate in all study visits.
  • Known insulin sensitivity factor (only applicable to subjects age 11 and older).
  • Subject's parent, guardian or legally authorized representative must be willing and able to provide written informed consent.
  • Subject must be willing and able to provide written signed and dated informed assent when appropriate.

Exclusion Criteria:

  • Subject is 18 years of age or older.
  • Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11 and older).
  • 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 has had an episode of severe hypoglycemia requiring intervention from a health care professional(i.e. EMT assistance, emergency room visit, or hospital admission) within the last six (6) months (only applicable to subjects age 11 or older).
  • Subject has had an episode of diabetic ketoacidosis (DKA) within the last (3) months (only applicable to subjects age 11 or older).
  • Subject is currently participating in another clinical trial.
  • Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities (only applicable to subjects age 6 and older).
  • Subject has both hemoglobin (Hb) and hematocrit levels that are below the normal ranges (only applicable to subjects age 6 and older). The low end of the normal range for Hb is as follows: for males and females aged 6-12 years old it is 11.5 g/dL; for males aged 12-17 it is 13.0 g/dL; for females aged 12-17 it is 12.0 g/dL. The low end of the normal hematocrit for males and females aged 6-12 is 35%; 37% for males aged 12-17 and 36% for females aged 12- 17).
  • 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.
  • 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): NCT03820050


Locations
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United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
United States, Colorado
Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 94502
United States, Texas
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Study Director: Shridhara Karinka, Ph.D. Abbott Diabetes Care

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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT03820050     History of Changes
Other Study ID Numbers: ADC-US-VAL-18175
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
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: Yes
Pediatric Postmarket Surveillance of a Device Product: No

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