The International Diabetes Closed Loop (iDCL) Trial: Protocol 1

The protocol is a 3-month parallel group multi-center randomized trial designed to compare
Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP).
Approximately 126 subjects will be entered into the randomized trial at approximately seven
clinical sites in the United States, such that at least 110 subjects complete the randomized
trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of
randomizing 126 subjects.

In order to have a broad range of glycemic control among the subjects, a study goal will be
to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c < 7.5%.

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

3. Age ≥14 years old

4. HbA1c level <10.5% at screening

5. For females, not currently known to be pregnant

6. Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1
analogs, SGLT2 inhibitors) during the study

7. Willingness, if not assigned to the closed-loop group, to avoid use of any closed-loop
control system for the duration of the clinical trial

8. Willingness to suspend use of any personal CGM for the duration of the clinical trial
once the unblinded study CGM is in use

9. Willingness to establish network connectivity on at least a weekly basis either via
local Wifi network or via a study-provided cellular service

10. 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)

11. Investigator has confidence that the subject can successfully operate all study
devices and is capable of adhering to the protocol

12. For subjects less than 18 years old, living with one or more parent/legal guardian
(referred to subsequently as diabetes care partner) committed to participating in
study training for emergency procedures for severe hypoglycemia and able to contact
the subject in case of an emergency

Exclusion Criteria:

1. Medical need for chronic acetaminophen

2. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs,
SGLT2 inhibitors) in the 3 months prior to enrollment

3. Hemophilia or any other bleeding disorder

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 labeling

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

6. Use of a closed-loop system within the last month prior to enrollment

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