Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes
NCT ID: NCT03303196
Last Updated: 2020-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2018-04-09
2019-09-30
Brief Summary
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Detailed Description
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Current treatment approaches with intermittent subcutaneous insulin administration or insulin pump therapy offer inadequate glycemic control in these individuals. We propose a novel approach to the management of these individuals with the bihormonal bionic pancreas to replace both hormones, insulin and glucagon, through an automated glycemic management system.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Bihormonal bionic pancreas admission
Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
Bihormonal Bionic Pancreas
A 4-day inpatient admission in which subjects will wear the bihormonal pancreas. The bihormonal pancreas will be placed upon admission and there will be 1 day of run-in. This will be followed by 3 days of data collection for comparison with the data obtained from the standard of care during the control admission.
Standard care admission
Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
No interventions assigned to this group
Interventions
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Bihormonal Bionic Pancreas
A 4-day inpatient admission in which subjects will wear the bihormonal pancreas. The bihormonal pancreas will be placed upon admission and there will be 1 day of run-in. This will be followed by 3 days of data collection for comparison with the data obtained from the standard of care during the control admission.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of hyperinsulinism.
3. Previous pancreatectomy.
4. Diabetes confirmed by one or more of the following:
* Glycosylated A1c \> 6.4%.
* Fasting glucose \> 125 mg/dL.
* 2-hour post-prandial glucose \> 200 mg/dL.
* Random glucose \> 200 mg/dL with symptomatic hyperglycemia.
5. On insulin therapy with a regimen of at least 11 units/kg/day.
6. Treatment with subcutaneous insulin by pump at the time of recruitment.
7. Prescription medication regimen stable for \> 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the site PI).
8. Females \> 11 years of age must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
9. Informed consent, parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria
2. Evidence of a medical condition that might alter results or compromise the interpretation of results, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure.
3. Evidence of severe hematologic abnormality including severe anemia and/or thrombocytopenia.
4. Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radio frequency interference.
5. Unable to completely avoid acetaminophen for duration of study.
6. History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
7. Established history of allergy or severe reaction to adhesive or tape that must be used in the study.
8. Use oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors anti-diabetic medications.
9. Any investigational drug use within 30 days prior to enrollment.
10. Pregnant or lactating females.
11. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
6 Years
30 Years
ALL
No
Sponsors
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Boston University
OTHER
Massachusetts General Hospital
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Diva De Leon, MD, MSCE
Director, Congenital Hyperinsulinism Center
Principal Investigators
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Diva D De Leon, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Arpana Rayannavar, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
El-Khatib FH, Russell SJ, Magyar KL, Sinha M, McKeon K, Nathan DM, Damiano ER. Autonomous and continuous adaptation of a bihormonal bionic pancreas in adults and adolescents with type 1 diabetes. J Clin Endocrinol Metab. 2014 May;99(5):1701-11. doi: 10.1210/jc.2013-4151. Epub 2014 Jan 31.
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.
El-Khatib FH, Balliro C, Hillard MA, Magyar KL, Ekhlaspour L, Sinha M, Mondesir D, Esmaeili A, Hartigan C, Thompson MJ, Malkani S, Lock JP, Harlan DM, Clinton P, Frank E, Wilson DM, DeSalvo D, Norlander L, Ly T, Buckingham BA, Diner J, Dezube M, Young LA, Goley A, Kirkman MS, Buse JB, Zheng H, Selagamsetty RR, Damiano ER, Russell SJ. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet. 2017 Jan 28;389(10067):369-380. doi: 10.1016/S0140-6736(16)32567-3. Epub 2016 Dec 20.
De Leon DD, Stanley CA. Mechanisms of Disease: advances in diagnosis and treatment of hyperinsulinism in neonates. Nat Clin Pract Endocrinol Metab. 2007 Jan;3(1):57-68. doi: 10.1038/ncpendmet0368.
Rayannavar A, Mitteer LM, Balliro CA, El-Khatib FH, Lord KL, Hawkes CP, Ballester LS, Damiano ER, Russell SJ, De Leon DD. The Bihormonal Bionic Pancreas Improves Glycemic Control in Individuals With Hyperinsulinism and Postpancreatectomy Diabetes: A Pilot Study. Diabetes Care. 2021 Nov;44(11):2582-2585. doi: 10.2337/dc21-0416. Epub 2021 Sep 13.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Children's Hospital of Philadelphia \| Congenital Hyperinsulinism Center Website
Boston University \| Bionic Pancreas Website
Other Identifiers
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17-014144
Identifier Type: -
Identifier Source: org_study_id