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

Not Recruiting

Trial ID: NCT02536950


This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.

Official Title

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

Stanford Investigator(s)

Bruce Buckingham
Bruce Buckingham

Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus


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

   - 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

   - 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


device: Fixed set point

device: Variable set point

device: Fixed set point

device: Variable set point

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paula Clinton, RD, CDE