![]() It provides real-time glucose readings for up to 10 days, both day and night. The FreeStyle Libre system measures glucose levels through a small sensor - the size of two stacked quarters - applied to the back of your upper arm. How Does Continuous Glucose Monitoring With the FreeStyle Libre System Work? The revolutionary system eliminates the hurdles of traditional glucose monitoring and requires no routine fingersticks or fingerstick calibrations.Īcross the globe, more than 400,000 people are using the FreeStyle Libre, and the system has been clinically proven to be accurate, stable and consistent. Food and Drug Administration's approval of the FreeStyle ® Libre is that life-changing experience. What if you could take the pain and inconvenience out of glucose monitoring and experience a better way of managing the condition?įor the 30.3 million Americans who have diabetes, the U.S. These inconveniences can make it difficult to stick to a diabetes management plan, opening the door for complications to arise. If you or someone you love has diabetes, you're probably familiar with the tedious routine of glucose monitoring, the painful fingersticks to draw a drop of blood and the bulky traditional glucose monitoring equipment requiring daily calibrations. Subject is unsuitable for participation due to any other cause as determined by the Investigator.Daily diabetes monitoring hurts.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.Such conditions include but are not limited to: 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.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 donated blood within 112 days (3.7 months) prior to the beginning of the study activities.Subject is currently participating in another clinical trial.EMT assistance, emergency room visit, or hospital admission) within the last three (3) months. ![]() Subject has had an episode of severe hypoglycemia requiring intervention from a health care professional (i.e.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 extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.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 known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.Subject has a history of hypoglycemia unawareness.Additional criteria for hypoglycemia induction.Subject must be willing and able to provide written signed and dated informed consent.At the time of enrollment, subject must be available to participate in all study visits. ![]() ![]()
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