Update: The FreeStyle Libre 2 system was launched in November 2020. There are unregulated devices available which will take readings from the sensor every 5 minutes and transmit them to your smart phone, such as Miao Miao and Blucon. Unlike CGM, Flash or Libre does not transmit so it will not alert you to low or high glucose levels until you ‘flash’ the sensor.
Subject is unsuitable for participation due to any other cause as determined by the Investigator.What’s the difference between flash glucose sensing and continuous glucose monitoring?įlash glucose sensing (FGS) is similar to continuous glucose monitoring (CGM) in that they both use a sensor and display trends. 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. Such conditions include but are not limited to: 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. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities. Subject currently is participating in another clinical trial. 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 must be willing and able to provide written signed and dated informed consent. 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. Subject must be able to read and understand English. Subject must be willing to fast four individual times prior to in-clinic visits, each fast lasting a minimum of eight hours. Willing to perform a minimum of 8 finger sticks per day during 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.Subject must be at least 18 years of age.Each in-clinic visit is anticipated to last approximately 10 hours. Subjects will have four (4) in-clinic visits during which intravenous blood draws and YSI reference testing will occur. Subjects will make seven (7) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1).
Subjects will be instructed to report any problems with the device. Subjects will follow the same BG testing schedule during in-clinic visits. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per day using the primary Reader. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). All Readers will be masked during the study (i.e. Each Sensor will have a paired Reader that will be given to the subject. Subjects will wear two Sensors of Three unique sensor lots. Up to 60 subjects will be enrolled at up to six clinical research sites in the United States. Why Should I Register and Submit Results?.
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