Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas

Completed · Not applicable

Conditions studied: Diabetes Mellitus

In brief

The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.

Key facts

Study ID

NCT01161862

Run by

Boston University Charles River Campus

People needed

24

Starts

2010-07-01

Expected to finish

2013-06-01

Last updated by the study team

2017-11-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 12 years or older with clinical type 1 diabetes for at least one year
• Weight > 41 kg
• Otherwise healthy (mild chronic disease allowed if well controlled)
• Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
• Body mass index (BMI) between 20 and 35 for subjects >18 years of age or BMI between the 5th and 95th percentile for age for subjects < 18 years of age
• Total daily dose (TDD) of insulin that is < 1 U/kg
• Stimulated C-peptide < 0.1 nmol/L at 90 minutes after liquid mixed meal by DCCT protocol
• Hemoglobin A1c <= 9%
• Prescription medication regimen stable for 1 month

You may not qualify if…

• Unable to provide informed consent for subjects > 18 years of age or unable to provide assent if < 18 years of age
• Unable to comply with study procedures
• Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Potential subjects enrolled in trials of passive monitoring equipment are not excluded.
• Anemia (HCT less than normal for age and sex)
• Alanine aminotransferase > 3 fold above upper limit of normal
• Untreated or inadequately treated hyperthyroidism or hypothyroidism
• Pregnancy
• Renal insufficiency (creatinine clearance ≤ 50 ml/min)
• Any known history of coronary artery disease
• Abnormal EKG including, but not limited to evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), arrhythmia, tachycardia, and prolonged QT interval (> 440 ms)
• Congestive heart failure
• History of TIA or stroke
• Acute illness or exacerbation of chronic illness
• History of seizures
• History of pheochromocytoma (fractionated metanephrines will be tested in patients with history suggestive of pheochromocytoma)
• History of adrenal disease or tumor
• History of pancreatic tumor, including insulinoma
• History of impaired gastric motility or gastroparesis requiring pharmacological or surgical treatment
• Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription)
• Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year)
• Impaired cognition or altered mental status.
• Hypertension (blood pressure > 140/90 or > 95% for age, height and weight in subjects < 18 years of age) at the time of screening
• Use of medications that reduce gastric motility (e.g. narcotics, anti-spasmodics, anticholinergics).
• Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
• Use non-insulin, injectable anti-diabetic medications

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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