The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas
NCT ID: NCT02105324
Last Updated: 2017-10-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2014-06-30
2014-08-31
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
CROSSOVER
TREATMENT
NONE
Study Groups
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Bionic Pancreas
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
Bionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.
Usual Care
Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Usual Care
As a comparator control, usual diabetes camp care with the participant's own insulin pump.
Interventions
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Bionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.
Usual Care
As a comparator control, usual diabetes camp care with the participant's own insulin pump.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diabetes managed using an insulin infusion pump for ≥ three months
* Willing to wear two infusion sets and continuous glucose monitoring (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily)
* Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion)
Exclusion Criteria
* Unable to comply with study procedures
* Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
* End stage renal disease on dialysis (hemodialysis or peritoneal dialysis)
* Pregnancy (positive urine human chorionic gonadotropin \[HCG\])
* History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion
* Personal history of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma
* History of prolonged QT or arrhythmia, congenital heart disease or current known cardiac disease
* Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes (T1D) at the time of the study
* Seizure disorder, history of any seizure within the last two years, or ongoing treatment with anticonvulsants
* Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation.
* Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radio-frequency (RF) interference
* Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2 (SGLT-2) inhibitors) anti-diabetic medications
* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
* Unwilling or unable to completely avoid acetaminophen during the comparator and bionic pancreas arms of the study
* History of eating disorder such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
* History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
* Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures
6 Years
11 Years
ALL
No
Sponsors
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Boston University
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Steven J. Russell, MD, PhD
Assistant Professor of Medicine
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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Russell SJ, Hillard MA, Balliro C, Magyar KL, Selagamsetty R, Sinha M, Grennan K, Mondesir D, Ekhlaspour L, Zheng H, Damiano ER, El-Khatib FH. Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):233-243. doi: 10.1016/S2213-8587(15)00489-1. Epub 2016 Feb 3.
Related Links
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Information about this and related studies
Other Identifiers
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2014P000630
Identifier Type: -
Identifier Source: org_study_id