A Pilot Test of t:Slim X2 With Control-IQ Technology

The objective of the study is for clinical staff to gain experience using the proposed
artificial pancreas system named t:slim X2 with Control-IQ Technology and assess usability in
a supervised setting prior to initiating home use in a Training protocol.

Inclusion Criteria:

To be eligible for the study, a subject must meet the following 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 18.0 to <75.0 years

4. Hemoglobin A1c <10.5%

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

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

8. 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). Willingness to switch to lispro (Humalog) or aspart (Novolog) if
using glulisine (Apidra).

9. Total daily insulin dose (TDD) at least 10 U/day and ≤100 U/day

10. Weight at least 25 kg and not greater than 140 kg

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 or loss of
consciousness in the 6 months prior to enrollment

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

4. Hemophilia or any other bleeding disorder

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

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

7. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc.
or TypeZero Technologies, LLC, 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