Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller

Study participants will be asked to use the CGM and the study insulin pump provided for
approximately 4 to 5 days prior to initiation of the HCL PID-IFB system in a hotel setting
for another 4 to 5 days. All participants with diabetes and the parent/ guardian of
participants < 18 years of age will be asked to stay overnight in a hotel while the HCL
PID-IFB system is on and to remain close to Stanford University during the day. For
participants > 18 years of age, designated remote monitors will be asked to receive alerts
for low/ high glucose levels.

Enrolled participants will be asked to complete evaluations to describe their user
experience/ evaluation of the system.Each participant had a companion (parent/ legal guardian
of participants < 18 years of age, or the designate remote monitor for participants > 18
years of age) who will consent to monitor the participant and complete an evaluation, but
will not be considered enrolled in the study.

Inclusion Criteria:

- Clinical diagnosis of type 1 diabetes (The diagnosis of type 1 diabetes is based on
the investigator's judgment; C peptide level and antibody determinations are not
needed.)

- Daily insulin therapy for at least one year

- Age between 14.0 to 40.0 years of age. The first 9 subjects (between all 3 centers)
will be over 18 years old.

- Subject has performed an average of at least 3 meter glucose readings per day in the
preceding 2 weeks

- Subject has used a downloadable insulin pump for at least 3 months

- Subject comprehends written English

- Female patients who are sexually active must be on acceptable method of contraception
e.g. oral contraceptive pill, diaphragm, IUD

- Female patients must have a negative urine pregnancy test

- Informed Consent Form signed by the subject and/or parent and assent signed by the
subject if < age 18

- Parent/guardian (for subjects < 18 years) and subject understand the study protocol
and agree to comply with it. Both parents must sign if possible.

- Total daily insulin requirement greater than 0.4 units/kg/day over the preceding two
weeks.

- No expectation that subject will be moving out of the area of the clinical center
during the study.

- Adults will need to be working within 20 minutes of our research staff during the day.

- A person willing to fulfill the role of a remote monitor (such as parent, spouse or
significant other).

Exclusion Criteria:

- Subject has a medical disorder that in the judgment of the investigator will affect
the wearing of the devices or the completion of any aspect of the protocol

- Diabetic ketoacidosis in the past month

- History of seizure or loss of consciousness in the last 6 months

- Subject has a respiratory condition such as asthma, treated with systemic or inhaled
corticosteroids in the previous 6 months or cystic fibrosis

- Subject has a history of any cardiac or vascular disorder such as myocardial
infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting,
transient ischemic attack, cerebrovascular accident, angina, congestive heart failure,
arrhythmia or thromboembolic disease

- Subject has a history of liver or kidney disease (other than microalbuminuria)

- Systolic blood pressure > 140 mmHg on screening visit

- Diastolic blood pressure > 90 mmHg on screening visit

- Subject has active Graves' disease

- Subjects with inadequately treated thyroid disease or celiac disease

- Subject has a neurologic disorder that in the judgment of the investigator will affect
completion of the protocol

- Either the subject or the subject's primary caregiver has received inpatient
psychiatric treatment in the past 6 months

- Subject has a history of diagnosed medical eating disorder

- Subject has a history of known illicit drug abuse

- Subject has a history of known prescription drug abuse

- Subject has a history of current alcohol abuse

- Subject has a history of visual impairment which would not allow subject to
participate

- Subject has an active skin condition that would affect sensor placement

- Subject has adhesive allergies

- Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or
glargine)

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

- Current use of oral/inhaled glucocorticoids or other medications, which in the
judgment of the investigator would be a contraindication to participation in the study

- Subject is currently on beta blocker medication

- Subject is currently participating in another investigational study (drug or device)

- Subject is deemed by the investigator to be unwilling or unable to follow the protocol