Status:
COMPLETED
FreeStyle Libre Flash Accuracy Study
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Brief Summary
This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 8 2018
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03257501
Start Date
August 22 2017
End Date
January 8 2018
Last Update
January 9 2018
Active Locations (4)
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1
William Sansum Diabetes Center
Santa Barbara, California, United States, 93105
2
Diablo Clinical Research
Walnut Creek, California, United States, 94598
3
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
4
Rainier Clinical Research
Renton, Washington, United States, 98057