Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT01762059

Run by

Massachusetts General Hospital

People needed

32

Starts

2013-01-01

Expected to finish

2014-06-01

Last updated by the study team

2017-07-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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