NCT02536950CompletedNot Applicable
An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Bruce A. Buckingham1 site in 1 country16 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Mean glucose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Device Feasibility
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Blinded Sensor
No Intervention
Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week
Fixed set point
Experimental
Subjects will be in a hotel and use a fixed set point for glucose control for two days initialized at 130 mg/dl. The setpoint will be adjusted, if necessary, over the two days in the hotel before they are sent home for 5 days
Intervention: Fixed set point (Device)
Variable Set Point
Experimental
Subjects will begin using a "variable" setpoint which will make adjustments based on their past glucose control over the previous day
Intervention: Variable set point (Device)
Outcomes
Primary Outcomes
Mean glucose
Time Frame: change over 5 days
Dexcom G4P AP mean glucose
Secondary Outcomes
- % time <50 mg/dl(change over 5 days)
- % time <70 mg/dl(change over 5 days)
- % time 70-120 mg/dl(change over 5 days)
- % time 70-180 mg/dl(change over 5 days)
- % time >180 mg/dl(change over 5 days)
- % time >250 mg/dl(change over 5 days)
- % time < 60 mg/dl(Change over 5 days)
Investigators
Bruce A. Buckingham
Professor of Pediatrics (Endocrinology), MD
Stanford University
Study Sites (1)
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