Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

Inclusion Criteria:

   - 1. Clinical diagnosis, based on investigator assessment, of T1D treated with insulin
   via an insulin pump or injections for at least 1 year, with no major change in the
   intensity of insulin therapy in the past 3 months (e.g. switching from injections to
   pump)

   - 2. Age ≥6.0 years old

   - 3. For participants <18 years old, living with one or more parents or guardians
   committed to participating in training and able to contact the participant in case of
   an emergency

   - 4. For females, not currently known to be pregnant

   - - If female and sexually active, must agree to use a form of contraception to prevent
   pregnancy while a participant in the study. A negative serum or urine pregnancy test
   will be required for all females of child-bearing potential. Subjects who become
   pregnant will be discontinued from the study. Also, subjects who during the study
   develop and express the intention to become pregnant within the timespan of the study
   will be discontinued.

   - 5. Investigator has confidence that the participant can successfully use all study
   devices and is capable of adhering to the protocol

Exclusion Criteria:

   - 1. Anticipated need to use acetaminophen during study participation

   - 2. Participation in another pharmaceutical or device trial at the time of enrollment
   or plan to participate in another study during the time period of participation in
   this study

   - 3. Employed by, or having immediate family members employed by Tandem; or having a
   direct supervisor at place of employment who is also directly involved in conducting
   the clinical trial (as a study investigator, coordinator, etc.); or having a
   first-degree relative who is directly involved in conducting the clinical trial

   - 4. A condition, which in the opinion of the investigator or designee, would put the
   participant or study at risk including any contraindication to the use of any of the
   study devices per FDA labelling

   - - Individuals should not be enrolled with uncontrolled thyroid disease, renal failure
   (e.g., dialysis or estimated glomerular filtration (eGFR) <30), hemophilia or another
   major bleeding disorder, or unstable cardiovascular disease.

   - - Laboratory testing and other work up needed to determine that an individual is a
   suitable candidate for the study should be performed as part of usual care.