Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring, CGM, outpatient, insulin pump
Eligibility Criteria
Inclusion Criteria:
- Age 21 years or older with type 1 diabetes for at least one year
- Stimulated C-peptide < 0.1 nmol/L at 90 minutes after liquid mixed meal by the DCCT protocol
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment
- Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled)
Exclusion Criteria:
- Unable to provide informed consent
- Unable to comply with study procedures
- Total daily dose (TDD) of insulin that is > 1.5 U/kg
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
- Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when BG is < 50 mg/dl)
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
- Any known history of coronary artery disease (CAD)
- Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
- Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
- History of TIA or stroke.
- History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor
- Untreated or inadequately treated mental illness
- Current alcohol abuse or substance abuse
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
- Use non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
- Unwilling or unable to completely avoid acetaminophen
- ALT > 3-fold upper limit of normal
- Albumin < 3 g/dl
- Body mass index less than18 or greater than 35
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Bi-homonal Bionic Pancreas
Usual Care
Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.
Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM