International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
The objective of the study is for clinical staff to gain experience using the proposed
 artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home
 usability prior to initiating a large randomized controlled trial.
Participation in this study will require 5 study visits over 2-4 weeks.

 -  Visit 1: screening/enrollment visit to assess study eligibility.

 -  Visit 2: continuous glucose monitor (CGM) training and initiation session based upon
 current or prior use of a CGM; if subject doesn't currently use a CGM, subject will be
 trained and may be asked to wear the CGM at home for 1 week.

 -  Visit 3: subjects will be taught how to use the study insulin pump.

 -  Visit 4: subjects will be trained on the use of inControl and wear it at home for 14
 days.

 -  Visit 5: subjects will return study equipment and to complete questionnaire.
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

 Exclusion Criteria

 1. More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to
 enrollment

 2. More than one episode of severe hypoglycemia involving seizure of loss of
 consciousness in the 6 months prior to enrollment

 3. Medical need for chronic acetaminophen

 4. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists,
 Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and
 naturaceuticals).

 5. Hemophilia or any other bleeding disorder

 6. A condition, which in the opinion of the investigator or designee, would put the
 participant or study at risk

 7. Participation in another pharmaceutical or device trial at the time of enrollment or
 during the study

 8. Employed by, or having immediate family members employed by TypeZero Technologies, LLC