HbA1c Variation Study

Exclusion Criteria

• •10. Subject is currently undergoing dialysis or planning to receive dialysis during the course of the study
• •11. History of blood transfusion in the last 3 months or planned blood transfusion during the course of the study.
• •12. Subject is currently planning to undergo a major medical intervention expected to significantly alter red cell life span, i.e. chemotherapy, major surgery requiring blood transfusions, etc.
• •13. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• •14. Subjects age 18 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration study (applicable to female subjects only). Subjects age 17 and younger: Subject is known to be pregnant at the time of study enrollment or is planning to become pregnant during the study (applicable to female subjects only).
• •15. 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.
• •16. Subject has a pacemaker or any other neurostimulators.
• •17. 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.
• •18. Subject is currently participating in another interventional clinical trial.
• •19. Subject is unsuitable for participation due to any other cause as determined by the Investigator.