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FreeStyle Libre Flash 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03141892
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Brief Summary:
This is a pivotal, non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.

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

Detailed Description:

Up to 60 subjects will be enrolled at up to six clinical research sites in the United States. Subjects will wear two Sensors of Three unique sensor lots. 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 8 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 follow the same BG testing schedule during in-clinic visits. Subjects will be instructed to report any problems with the device.

Subjects will make seven (7) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have four (4) in-clinic visits during which intravenous blood draws and YSI reference testing will occur. Each in-clinic visit is anticipated to last approximately 10 hours.


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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Libre Flash Glucose Monitoring System Accuracy Study
Actual Study Start Date : April 13, 2017
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
Diabetes Mellitus, Type 1 and Type 2
Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
Device: FreeStyle Libre Flash Glucose Monitoring System
Blood Glucose Monitoring




Primary Outcome Measures :
  1. System Performance [ Time Frame: Approximately 32 hours ]
    System performance will be characterized with respect to YSI reference venous plasma sample measurements.

  2. System related adverse device effects and serious adverse effects [ Time Frame: Up to 42 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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).
Criteria

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject must have type 1 or type 2 diabetes.
  • Subject 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 8 finger sticks per day during the study.
  • Subject must be willing to fast four individual times prior to in-clinic visits, each fast lasting a minimum of eight hours.
  • Subject 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 consent.

Exclusion Criteria:

  • Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  • Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (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 currently is participating in another clinical trial.
  • Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
  • Subject is anemic.
  • Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to:
  • History of HIV, Hepatitis B or C
  • 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): NCT03141892


Locations
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United States, California
William Sansum Diabetes Center
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
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Study Director: Shridhara Karinka, PhD Abbott Diabetes Care

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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT03141892     History of Changes
Other Study ID Numbers: ADC-US-VAL-17164
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
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
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