- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03257501
FreeStyle Libre Flash Accuracy Study
January 8, 2018 updated by: Abbott Diabetes Care
FreeStyle Libre Flash Glucose Monitoring System Accuracy Study
This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Up to 150 subjects will be enrolled at four (4) 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 be instructed to report any problems with the device.
Subjects will make eight (8) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1).
Subjects will have five (5) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.
Study Type
Observational
Enrollment (Actual)
104
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Santa Barbara, California, United States, 93105
- William Sansum Diabetes Center
-
Walnut Creek, California, United States, 94598
- Diablo Clinical Research
-
-
Idaho
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Idaho Falls, Idaho, United States, 83404
- Rocky Mountain Diabetes & Osteoporosis Center
-
-
Washington
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Renton, Washington, United States, 98057
- Rainier Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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 five 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 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.
- Subject is anemic as determined by the Investigator.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Performance with respect to YSI reference venous plasma sample measurements.
Time Frame: Approximately 35 hours
|
System performance will be characterized with respect to YSI reference venous plasma sample measurements.
|
Approximately 35 hours
|
System Related adverse device effects
Time Frame: Up to 51 days
|
System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
|
Up to 51 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shridhara K Alva, PhD, Abbott Diabetes Care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 22, 2017
Primary Completion (ACTUAL)
January 8, 2018
Study Completion (ACTUAL)
January 8, 2018
Study Registration Dates
First Submitted
August 18, 2017
First Submitted That Met QC Criteria
August 21, 2017
First Posted (ACTUAL)
August 22, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 9, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- ADC-US-VAL-17166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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