FreeStyle Libre Flash Glucose Monitoring System Accuracy Study

Completed

Conditions studied: Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT03141892

Run by

Abbott Diabetes Care

People needed

50

Starts

2017-04-13

Expected to finish

2017-05-30

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• William Sansum Diabetes Center — Santa Barbara, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Rocky Mountain Diabetes & Osteoporosis Center — Idaho Falls, Idaho, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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