Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics

Inclusion Criteria

• Individual is 2 - 80 years of age at time of enrollment.
• Subject has a clinical diagnosis of type 1 or type 2 diabetes:
• If subject is 14-80 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
• If subject is 2-13 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
• If subject is participating in YSI™* FST , subject has adequate venous access as assessed by investigator or appropriate staff.
• Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity factor(s). Subjects without ratios may participate under observation only.

Exclusion Criteria

• Subject will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
• Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
• Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
• Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
• Subject is a sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by investigator.
• Subject is female and plans to become pregnant during the course of the study.
• Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment.
• Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
• Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
• Subject has a history of a seizure disorder.
• Subject has central nervous system or cardiac disorder resulting in syncope.
• Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
• If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
• Subject has a history of adrenal insufficiency.
• Subject is a member of the research staff involved with the study.