The True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus

Prior treatment

• Participant has had a severe hypoglycemic event requiring 3rd party assistance within the past 6 months prior to enrollment.
• Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
• Participant has donated or lost \>5% of estimated blood volume or more of their blood volume within 45 days prior to Day 0.
• Participant 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 observational study is acceptable.

Other illness

• History of skin adhesive tolerance issues in the area of sensor placement.
• Conditions which may predispose subjects to hypoglycemia including, but not limited to, thyroid disease which is not well controlled, adrenal insufficiency, high dose steroid use in recent past or planned during study, significant renal or liver disease.
• Participant has a history of a seizure disorder.
• Any medical history of malignant melanoma or breast cancer.
• Medical history of any other cancers within the last five years except adequately treated basal cell or squamous carcinoma of the skin, or cervical carcinoma in-situ.
• Medical history of stroke, transitory cerebral ischemia, myocardial infarction, unstable angina or heart failure with in the past 12 months.
• History of alcohol or drug abuse within the last year.
• Any condition that in the opinion of the investigator may interfere successful completion of study procedures.

Lab values

• For 13-17 years old only: Absence of established correction factor for high glucose.
• Hematocrit below 10% under the lower limit of the normal range by less than 3 month old laboratory test in history, a centrifuge or POC meter test.

Age

• Inability or unwillingness to conform to the required protocol procedures including both participant and guardian giving informed consent, and for 7-17 years old only also hypoglycemia and hyperglycemia induction.

Other

• Insulin meal dosing based on fixed dose regimens.
• For 7-17 year old: inadequate intravenous access on arms.
• For girls of reproductive potential: pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
• Planned MRI, CT scan or diathermia procedure for the duration of the study.
• Participant is a member of the research staff involved with the study.

• Patients with T1DM diagnosed for at least 6 months aged 2-17 years old, inclusive.
• Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen or CSII, irrespective of delivery device(s). For this criterion, "stable treatment regimen" is considered no changes in prescribed number of insulin deliveries a day, and a change in total daily insulin dose of less than 10%.