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Stanford, California 94305


Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT02536950


Primary Contact:

Principal Investigator
Bruce A Buckingham, MD
Stanford School of Medicine, Pediatric Endocrinology


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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