Prediabetes and Type 2 Diabetes Data Collection Study

Exclusion Criteria

• •Hospital admissions for diabetes ketoacidosis (DKA) or Hyperglycemic Hyperosmolar Nonketotic Syndrome (HHNS) in the last 6 months.
• •History of 2 or more episodes of severe hypoglycemia, which resulted in any of the following during the 6 months prior to screening:
• •Medical assistance by a third party (Caregiver needed to inject glucagon, ER visit, hospitalization) Coma Seizures
• •Subject has a skin condition for which he/she is unable to tolerate tape adhesive in the area of sensor placement.
• •Pregnancy (as demonstrated by a positive test at study entry) at time of screening or are planning to become pregnant during the study.
• •Subject has had any of the following cardiovascular events within 3 months of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, recent transient ischemic attack, cerebrovascular accident with sequelae, unstable angina, unstable congestive heart failure, unstable ventricular rhythm disturbances or thromboembolic disease.
• •Unstable thyroid disease. (changes in Thyroid medication in the last 90 days)
• •Subject has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from the time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study.
• •Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
• •Subject is currently using illicit drugs.
• •Subject is currently abusing prescription drugs.
• •Subject is currently abusing alcohol.
• •Subject has a history of visual impairment which would not allow him/her to participate in the study and perform all study procedures safely, as determined by the investigator.
• •Subject has elective surgery planned that requires general anesthesia during the course of the study.
• •Subject has a sickle cell disease, hemoglobinopathy, or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
• •Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
• •Subject diagnosed with current eating disorder such as anorexia or bulimia.
• •Subject is on dialysis.
• •Subject has eGFR \<45 confirmed by medical record.
• •Recent Pancreatitis. (\< 30 days)
• •Cancer/malignancy in treatment.
• •Cystic fibrosis.
• •Any other problem for which the investigator or the sponsor may believe that the subject will not be able to comply with the study. (e.g. use of hydroxyurea)