![]() ![]() Subject is unsuitable for participation due to any other cause as determined by the Investigator.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.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.Willing to have their blood sugar manipulated during in-clinic sessions.Subject must be able to read and understand English.Willing to perform a minimum of 8 finger sticks per day while wearing the sensor in the study.Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).Subject must have type 1 or type 2 diabetes.To achieve proper quality of life and reduce long-term problems, people are increasingly encouraged to take an active role in the management of their condition. Subject must be at least 18 years of age. This assessment will focus on FreeStyle Libre, flash glucose monitor for insulin treated individuals with type 1 and 2 diabetes (Type 1 and 2 DM).Why Should I Register and Submit Results?. ![]()
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