Diabetes Mellitus, Type 1
Conditions
Keywords
bionic pancreas, closed-loop control, artificial pancreas
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.
Interventions
DEVICEFixed set point
Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting.
DEVICEVariable set point
Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window.
Sponsors
Boston University
Massachusetts General Hospital
Bruce A. Buckingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose | change over 5 days | Dexcom G4P AP mean glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % 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 <50 mg/dl | change over 5 days | Fraction of Dexcom G4P AP readings \<60 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 |
| % time >180 mg/dl | change over 5 days | Fraction of Dexcom G4P AP readings \>180 mg/dl |
Countries
United States
Outcome results
None listed