Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bruce A. Buckingham

Collaborator: Massachusetts General Hospital

Stanford Investigator(s):

Intervention(s):

  • Device: Fixed set point
  • Device: Variable set point

Phase:

N/A

Eligibility


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

Ages Eligible for Study

18 Years - 44 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paula Clinton, RD, CDE
650-736-2313
Not Recruiting