Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial

Inclusion Criteria:

   - 1. Patients with T1DM or T2DM diagnosed for at least 6 months. 2. Individual is 18-80
   years old, inclusive, at the time of screening. 3. Must be and have been in stable
   treatment regimen for at least 1 month with a multiple daily insulin dosing regimen
   (at least two insulin doses with meals daily) or CSII using at least two bolus doses a
   day with meals, irrespective of delivery device(s).

Exclusion Criteria:

   - 1. History of skin adhesive tolerance issues in the area of sensor placement. 2. HbA1c
   > 9%. 3. Insulin meal dosing based on fixed dose regimens. 4. Absence of established
   correction factor for high glucose. 5. Hematocrit below 10% under the lower limit of
   the normal range. 6. Body mass index < 18.5 kg/m2. 7. Inadequate intravenous access on
   arms. 8. Participant has had a hypoglycemic seizure within the past 6 months prior to
   enrollment.

   9. Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6
   months prior to enrollment.

   10. Participant has a history of a seizure disorder. 11. Pregnancy, planned pregnancy
   within the study period, or unwillingness to use reliable contraception during the
   study period.

   12. Planned MRI, CT scan or diathermia procedure for the duration of the study.