an outpatient study of automated blood glucose control with an insulin-only bionic pancreas

Conditions: Diabetes Mellitus, Type 1

Summary: this is an open-label, non-randomized, pilot study to determine the safety and feasibility of the 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.

Eligibility 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

Keywords: bionic pancreas closed-loop control artificial pancreas