An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Not Applicable
Completed
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: Variable set pointDevice: Fixed set point
- Registration Number
- NCT02536950
- Lead Sponsor
- Bruce A. Buckingham
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Variable Set Point Variable set point Subjects will begin using a "variable" setpoint which will make adjustments based on their past glucose control over the previous day Fixed set point Fixed set point 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
- Primary Outcome Measures
Name Time Method Mean glucose change over 5 days Dexcom G4P AP mean glucose
- Secondary Outcome Measures
Name Time Method % time <50 mg/dl change over 5 days Fraction of Dexcom G4P AP readings \<60 mg/dl
% time <70 mg/dl change over 5 days Fraction of Dexcom G4P AP readings \<70 mg/dl
% time 70-120 mg/dl change over 5 days Fraction of Dexcom G4P AP readings 70-120 mg/dl
% time 70-180 mg/dl change over 5 days Fraction of Dexcom G4P AP readings 70-180 mg/dl
% time >180 mg/dl change over 5 days Fraction of Dexcom G4P AP readings \>180 mg/dl
% time >250 mg/dl change over 5 days Fraction of Dexcom G4P AP readings \>250 mg/dl
% time < 60 mg/dl Change over 5 days Fraction of Dexcom G4AP readings \< 60 mg/dl
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States