Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas
NCT ID: NCT01161862
Last Updated: 2017-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2010-07-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bi-hormonal with meal-priming bolus
The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal
Bi-hormonal (insulin and glucagon) artificial pancreas
Subjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump
Bi-hormonal without meal-priming bolus
The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
Bi-hormonal (insulin and glucagon) artificial pancreas
Subjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump
Interventions
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Bi-hormonal (insulin and glucagon) artificial pancreas
Subjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
* Established history of latex, adhesive, or tape allergy
* Inadequate venous access
* History of allergy to aspirin or any history of aspirin intolerance, including Reye syndrome, or gastric ulcer or bleeding associated with salicylates
* Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrands disorder, and idiopathic thrombocytopenic purpura (ITP)
* Peptic ulcer
* Unable to perform 30 minutes of moderate exercise on a treadmill or exercise bicycle
* Unable or unwilling to discontinue dietary supplements for at least 2 weeks prior to each CRC admission
* History of celiac disease
12 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Juvenile Diabetes Research Foundation
OTHER
The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Boston University Charles River Campus
OTHER
Responsible Party
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Edward R. Damiano
Associate Professor of Biomedical Engineering
Principal Investigators
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Steven J Russell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Damiano ER, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. A comparative effectiveness analysis of three continuous glucose monitors. Diabetes Care. 2013 Feb;36(2):251-9. doi: 10.2337/dc12-0070. Epub 2012 Dec 28.
Russell SJ, El-Khatib FH, Nathan DM, Magyar KL, Jiang J, Damiano ER. Blood glucose control in type 1 diabetes with a bihormonal bionic endocrine pancreas. Diabetes Care. 2012 Nov;35(11):2148-55. doi: 10.2337/dc12-0071. Epub 2012 Aug 24.
Related Links
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Related Info
Other Identifiers
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H-29293
Identifier Type: -
Identifier Source: org_study_id