Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

This proposal aims to demonstrate the superiority of the Closed-Loop Control (CLC), also
known as Artificial Pancreas (AP) named Tandem t:slim X2 with Control-IQ Technology and
assess usability in a supervised setting in a controlled environment compared with
state-of-the-art Sensor-Augmented Pump (SAP) therapy for the treatment of type 1 diabetes
(T1D) in adolescents.

Inclusion Criteria:

1. Criteria for documented hyperglycemia (at least 1 must be met):

- Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody
determinations are not required)

- The diagnosis of type 1 diabetes is based on the investigator's judgment

2. Criteria for requiring insulin at diagnosis (both criteria must be met):

- Daily insulin therapy for ≥ 6 months

- Insulin pump therapy for ≥ 3 months (note: must be willing to disable any glucose
suspend, predictive suspend, or artificial pancreas functionality on insulin pump
during study)

3. Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years

4. Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the
continuous glucose monitor.

5. Willingness to wear a continuous glucose sensor and physiological monitor for the
duration of the study

6. Not being pregnant at the start of the trial. All female subjects of childbearing
potential will be screened for pregnancy.

8. If the participant is less than 13 years of age and the parents or the study team
request it, at least one parent commit to stay with the study subject at the camp site 9. A
parent/caregiver is available for system training and will commit to be the main
responsible person for the use of the AP system at home

Exclusion Criteria:

1. Diabetic ketoacidosis in the past 6 months

2. Hypoglycemic seizure or loss of consciousness in the past 6 months

3. History of seizure disorder (except for hypoglycemic seizure)

4. History of any heart disease including coronary artery disease, heart failure, or
arrhythmias

5. History of altitude sickness

6. Chronic pulmonary conditions that could impair oxygenation

7. Cystic fibrosis

8. Current use of oral glucocorticoids, beta-blockers or other medications, which in the
judgment of the investigator would be a contraindication to participation in the
study.

9. History of ongoing renal disease (other than microalbuminuria).

10. Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or
Glargine).

11. Subjects requiring other anti-diabetic medications other than insulin (oral or
injectable).

12. Pregnancy

13. Presence of a febrile illness within 24 hours of start ski camp or acetaminophen use
while wearing the CGM. The camp study subject will not participate in the trial if
these conditions are met.

14. Medical or psychiatric condition that in the judgment of the investigator might
interfere with the completion of the protocol such as (for parent and/or child):

- Inpatient psychiatric treatment in the past 6 months

- Uncontrolled adrenal insufficiency

- Alcohol abuse