Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/3/2013 |
| Start Date: | January 2013 |
| End Date: | August 2013 |
| Contact: | Laurel Macey, BS |
| Email: | lmacey@partners.org |
| Phone: | 617-643-6702 |
The Beacon Hill Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
This study will test the hypothesis that a wearable automated bionic pancreas system that
automatically delivers both insulin and glucagon can improved glycemic control vs. usual in
the outpatient environment.
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
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