International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol

Inclusion Criteria

• •1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
• •2. Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
• •3. Age 14.0 to \<75.0 years
• •4. HbA1c level \<10.5% at screening
• •5. 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 premenopausal women who are not surgically sterile. 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.
• •6. Have care partner committed to participating in all training activities, knowledgeable at all times of the participants location, and being present and available to provide assistance when the system is being used at night
• •7. Willingness, if using the closed-loop system, to stop closed-loop when taking acetaminophen and avoid closed-loop for at least 4 hours afterward
• •8. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• •9. Willingness to establish network connectivity on a daily basis either via local Wi-Fi network or via a study-provided cellular service
• •10. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
• •11. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra)
• •12. Total daily insulin dose (TDD) less than 100 U/day