Clinical trial NCT02536950: An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Official title: An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: bionic pancreas
closed-loop control
artificial pancreas
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Boston University
name: Massachusetts General Hospital
First posted: 2015-09-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DEVICE_FEASIBILITY

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

Detailed description: 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

Primary outcomes:
measure: Mean glucose
timeFrame: change over 5 days
Secondary outcomes:
measure: % time <50 mg/dl
timeFrame: change over 5 days
measure: % time <70 mg/dl
timeFrame: change over 5 days
measure: % time 70-120 mg/dl
timeFrame: change over 5 days
measure: % time 70-180 mg/dl
timeFrame: change over 5 days
measure: % time >180 mg/dl
timeFrame: change over 5 days
measure: % time >250 mg/dl
timeFrame: change over 5 days
measure: % time < 60 mg/dl
timeFrame: Change over 5 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford School of Medicine, Pediatric Endocrinology
name: Bruce A Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References: