Bigfoot Biomedical Clinical Research Center (CRC) Trial

Inclusion Criteria:

1. Insulin dependent type 1 diabetes (T1D) for at least one year

2. Age ≥ 7 years of age

3. Weight ≥ 26 kg

4. HbA1c <10%

5. Total BASAL insulin dose (24 hour cumulative total) that is ≥ 5 units and ≤ 72 units
per day

6. Insulin regimen stable on either multiple daily insulin injections (MDI) or insulin
infusion pump therapy for ≥ 6 months. Regimen must include basal insulin and the use
of a rapid acting analog insulin to cover meals (e.g., Novolog, Humalog or Apidra)

- For participants on MDI, basal insulin must be either once daily Lantus
(Glargine) or once daily Levemir (Detemir). The once daily basal insulin dose
must be administered in the evening or at bedtime

7. Able to engage in at least 60 minutes of moderate exercise if ≥ 12 years of age
(e.g., walking or biking) and if ≥ 7 and < 12 years of age moderate activity (e.g.,
walking or active play)

8. Willing and able to refrain from use of any medication containing acetaminophen
during participation in the study (from the time of consent until study exit)

9. Willing and able to use Humalog insulin during the CRC admission

10. Able to speak and read English

Exclusion Criteria:

1. Females who are sexually active and able to conceive will be excluded if they are not
currently using or agree to continue use for the duration of the study an effective
method of contraception as determined by investigator

2. Females who are pregnant or intending to become pregnant during participation in the
trial

• Females who are capable of childbearing must have a negative pregnancy test at the
time of the screening visit and the pregnancy test must be repeated at enrollment if
it was done > 14 days prior

3. Presence of any condition that in the opinion of the investigator impairs the
participant's ability to use the system (e.g.,visual impairment that interferes with
ability to read the display)

4. Unable or unwilling to use study devices and follow study procedures including the
meal and exercise/ activity challenges in the CRC.

5. A current condition that would prevent the use of a study devices, including blood
glucose meter (BGM), continuous glucose monitoring (CGM) or insulin pump (CSII)

6. Current participation within the last 60 days in another clinical research study that
involves an intervention

• Participation in research studies involving data collection only is not an
exclusion (e.g.,T1D Exchange Registry)

7. Anticoagulant therapy other than aspirin

8. Severe hypoglycemia resulting in seizure OR loss of consciousness within 30 days
prior to enrollment

9. Diabetic ketoacidosis (DKA) requiring treatment in a healthcare facility within 30
days prior to enrollment

10. Current use (defined as within the last 3 months) of any medication intended to lower
glucose other than insulin (e.g., use of Metformin, Liraglutide, would be exclusions)

11. Current use (defined as within the last 3 months) of any medication that according to
the dose, frequency, and route of administration may result in hyperglycemia in the
investigator's judgment (e.g., current use of oral steroids)

• Regular use of inhaled or intranasal steroids is permitted

12. Presence of significant renal disease as evidenced by the presence of any of the
following:

- Current dialysis therapy

- Serum creatinine of ≥ 2.0 mg/dL within 30 days of enrollment

For screening purposes, serum creatinine levels will be tested in participants who
meet any of the following criteria:

- A≥10 year history of T1D

- Are ≥ 45 years of age

13. Presence or history of clinically significant cardiovascular disease (e.g.,
myocardial infarction, pacemaker, acute coronary syndrome, therapeutic coronary
intervention, coronary bypass or stenting procedure, atrial or ventricular
fibrillation, treatment for arrhythmia, stable or unstable angina, episode of chest
pain of cardiac etiology with associated ECG changes or positive stress test/ cardiac
catheterization, congestive heart failure, or cerebrovascular event)

14. ECG findings that indicate participation in the planned exercise/ activity session
would be contraindicated as determined by trained personnel at the respective
clinical center(s)

• For screening purposes, ECGs must be completed within 30 days of enrollment in
participants who meet any of the following criteria:

- A ≥ 10 year history of T1D and ≥ 20 years of age

- Are ≥ 45 years of age

15. History of adrenal insufficiency

16. A diagnosis of gastroparesis or impaired gastric motility that required
pharmacological or surgical treatment

17. Celiac Disease (CD) diagnosed < 12 months ago or CD that is currently inadequately
treated as determined by the investigator

18. Current alcohol abuse or eating disorder as determined by the investigator

19. Use or abuse of controlled substances without a prescription in the 6 months prior to
enrollment

20. History of hemoglobinopathy, sickle cell disease, or blood dyscrasia; blood
transfusion within 3 months of enrollment

21. Hematocrit that is above or below the normal reference range of the lab used within
14 days of enrollment

22. Presence or history of any medical or psychiatric condition, or the use of any
medication or therapy, that in the opinion of the investigator may be a
contraindication to participation in the study

23. Unstable hypertension, thyroid disease, or depression as evidenced by an adjustment
in therapy for the condition within the last 2 months, or as determined by
investigator