Full Day and Night Closed-Loop With DiAs Platform

This study is an early feasibility study that will test the efficacy of DiAs - a
smart-phone-based system compared to sensor augmented therapy in an outpatient setting.
Twelve study subjects with type 1 diabetes, six each at UVa and Stanford University, who
have experience with insulin pump use at two clinical sites will be recruited. The first six
subjects recruited will be aged 15-18 years and this will follow with recruitment of six
subjects aged 10-14 years. This study is designed to mimic the protocol at camp and will
include a period of light exercise after breakfast and moderate intensity physical activity
after lunch, with group activities such as soccer and volleyball. The duration of the
Outpatient in Residence Study will be 72 hours. The data will be reviewed by the Data Safety
Monitoring Board (DSMB) before proceeding to camp studies.

The camp study will recruit 48 subjects, with type 1 diabetes who have experience with
insulin pump therapy. Initial studies will be conducted at a camp with older participants
aged 15-35 years, with at least 5 of the campers between 15-18 years old. These studies will
be reviewed by the DSMB and, if safe, we will recruit additional children aged 10-14 years
of age. The duration of the Diabetes Camp Studies will be up to 7 days/6 nights.

Inclusion Criteria: To be eligible for the study, a subject must meet the following
criteria:

1. Clinical diagnosis of type 1 diabetes

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

- C peptide levels and antibody determinations are not required

2. Daily insulin therapy for ≥ 12 months

3. Insulin pump therapy for ≥ 3 months

4. Age 10.0 - 35.0 years

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

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

7. Female subjects who are sexually active must be on acceptable method of contraception
(e.g. oral contraceptive pill, diaphragm, IUD)

Exclusion Criteria: The presence of any of the following is an exclusion for the study:

1. Diabetic ketoacidosis in the past month

2. Hypoglycemic seizure or loss of consciousness in the past 3 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. Cystic fibrosis

6. 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.

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

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

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

10. Pregnancy - verbal denial of pregnancy obtained with telephone informed consent,
pregnancy test performed at camp before study devices are assigned.

11. Sexually active females who do not practice acceptable contraceptive methods to
prevent pregnancy.

12. Presence of a febrile illness within 24 hours of admission or acetaminophen use while
wearing the CGM. The subject may be rescheduled for Research House/hotel admission if
these criteria are not met. The camp study subject will not participate in the trial
if these conditions are met.

13. Medical or psychiatric condition that in the judgment of the investigator might
interfere with the completion of the protocol such as:

- Inpatient psychiatric treatment in the past 6 months

- Uncontrolled adrenal insufficiency

- Alcohol abuse