Freestyle Libre Flash Glucose Monitoring System

Completed

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.

Key facts

Study ID: NCT03607448
Run by: Abbott Diabetes Care
People needed: 153
Starts: 2018-07-23
Expected to finish: 2018-11-21
Last updated by the study team: 2018-11-29

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 while wearing the sensor in the study.
Subject must be able to read and understand English.
Willing to have their blood sugar manipulated during 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.
Subject must be willing and able to provide written signed and dated informed consent.
Additional criteria for hypoglycemia induction.
Known insulin sensitivity factor.

You may not qualify if…

Subject has a history of hypoglycemia unawareness.
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 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 three (3) months.
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 has both hemoglobin (Hb) and hematocrit levels that are 10% or more below the normal ranges (For reference low end of the normal range for Hb for males is 14 g/dL and for females is 12 g/dL; low end of the normal hematocrit is 40% for men and 36% for women).
Subject has concomitant medical condition which, in the opinion of the investigator, could 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, 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.

Where it is running

AMCR — Escondido, California, United States
Sansum Diabetes Research Institute — Santa Barbara, California, United States
Diablo Clinical Research — Walnut Creek, California, United States
Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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