An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas

A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will
consist of three 7-day study arms in the following order, one usual care arm, one bionic
pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only
arm with at dynamic glucose target.

Inclusion Criteria:

- Type 1 diabetes for at least 1 year

- insulin pump for ≥ 6 months

- Prescription medication regimen stable for > 1 month

- Subject comprehends written English

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

- Female patients must have a negative urine pregnancy test

- Informed Consent Form signed by the subject

- Lives and works within a 60 minute drive-time radius of Stanford University

- Willing to remain within a 60 minute drive-time radius of Stanford University during
all 3 of the 7-day study arms (21 days)

- Have someone over 18 years of age who lives with them,

Exclusion Criteria:

- Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of
marijuana within 1 month of enrollment, or other substance abuse (use within the last
6 months of controlled substances other than marijuana without a prescription)

- Subject has a history of diagnosed medical eating disorder

- 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, Neutral
Protamine Hagedorn, 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

- Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more
than 4 drinks in a day or use of marijuana during the trial

- Subject has active Graves' disease

- Subjects with inadequately treated thyroid disease or celiac disease

- History of liver disease Renal failure on dialysis

- Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other
pancreatic disease besides type 1 diabetes

- Any known history of coronary artery disease

- Abnormal EKG (electrocardiogram) consistent with coronary artery disease or increased
risk of malignant arrhythmia

- Congestive heart failure (established history of congestive heart failure , lower
extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)

- History of transient ischemic attack (TIA) or stroke

- Seizure disorder, history of any non-hypoglycemic seizure within the last two years,
or ongoing treatment with anticonvulsants

- History of hypoglycemic seizures (grand-mal) or coma in the last year

- History of pheochromocytoma:

- episodic or treatment refractory (requiring 4 or more medications to achieve
normotension) hypertension

- paroxysms of tachycardia, pallor, or headache

- personal or family history of MEN 2A (multiple endocrine neoplasia), MEN 2B,
neurofibromatosis, or von Hippel-Lindau disease

- History of adrenal disease or tumor

- Hypertension with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100
despite treatment

- Untreated or inadequately treated mental illness

- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be
susceptible to RF interference

- Unable to completely avoid acetaminophen for duration of study

- Established history of allergy or severe reaction to adhesive or tape that must be
used in the study

- History of eating disorder within the last 2 years, such as anorexia, bulimia, or
diabulemia or omission of insulin to manipulate weight

- History of intentional, inappropriate administration of insulin leading to severe
hypoglycemia requiring treatment

- Lives in or frequents areas with poor Verizon wireless network coverage (which would
prevent remote monitoring)

- Any factors that, in the opinion of the site principal investigator or overall
principal investigator, would interfere with the safe completion of the study