NCT03303196

Brief Summary

This is a pilot study designed to determine if the bihormonal bionic pancreas provides improved blood glucose control, compared to the current standard of care, in individuals with hyperinsulinism who developed diabetes after having a pancreatectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 27, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

October 2, 2017

Results QC Date

August 18, 2020

Last Update Submit

October 2, 2020

Conditions

HyperinsulinismDiabetesPancreatic DiseasesPancreatectomy; Hyperglycemia

Keywords

Post-Pancreatectomy DiabetesInsulin Therapy

Outcome Measures

Primary Outcomes (1)

  • Mean Plasma Glucose Level.

    Mean plasma glucose concentration, as measured by the Continuous glucose monitoring system (CGMS), during the final 2 days of the Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.

    Days 2-3 of each admission

Study Arms (2)

Bihormonal bionic pancreas admission

EXPERIMENTAL

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.

Device: Bihormonal Bionic Pancreas

Standard care admission

NO INTERVENTION

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.

Interventions

Bihormonal Bionic PancreasDEVICE

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.

Bihormonal bionic pancreas admission

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males or females age 6 to 30 years.
  • Diagnosis of hyperinsulinism.
  • Previous pancreatectomy.
  • Diabetes confirmed by one or more of the following:
  • Glycosylated A1c \> 6.4%.
  • Fasting glucose \> 125 mg/dL.
  • hour post-prandial glucose \> 200 mg/dL.
  • Random glucose \> 200 mg/dL with symptomatic hyperglycemia.
  • On insulin therapy with a regimen of at least 11 units/kg/day.
  • Treatment with subcutaneous insulin by pump at the time of recruitment.
  • 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).
  • 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.
  • Informed consent, parental/guardian permission (informed consent) and if appropriate, child assent.

You may not qualify if:

  • Unable to provide informed consent (e.g. impaired cognition or judgment).
  • 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.
  • Evidence of severe hematologic abnormality including severe anemia and/or thrombocytopenia.
  • Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radio frequency interference.
  • Unable to completely avoid acetaminophen for duration of study.
  • History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
  • Established history of allergy or severe reaction to adhesive or tape that must be used in the study.
  • Use oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors anti-diabetic medications.
  • Any investigational drug use within 30 days prior to enrollment.
  • Pregnant or lactating females.
  • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (6)

  • 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.

    PMID: 22923666BACKGROUND

  • 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.

    PMID: 24483160BACKGROUND

  • 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.

    PMID: 26850709BACKGROUND

  • 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.

    PMID: 28007348BACKGROUND

  • 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.

    PMID: 17179930BACKGROUND

  • 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.

    PMID: 34518377DERIVED

Related Links

MeSH Terms

Conditions

HyperinsulinismDiabetes MellitusPancreatic DiseasesHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDigestive System Diseases

Results Point of Contact

Title
Lauren Mitteer
Organization
Children's Hospital of Philadelphia
MitteerL@email.chop.edu
267-426-9915

Study Officials

  • Diva D De Leon, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Arpana Rayannavar, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This will be an open-label, pilot clinical trial to assess efficacy and safety of the bihormonal bionic pancreas in children and young adults with HI who have developed post-pancreatectomy diabetes. Subjects will be studied during two research inpatient admissions at the CHOP HI Center. The order of the interventions will be randomized.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Congenital Hyperinsulinism Center

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

April 9, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 27, 2020

Results First Posted

October 27, 2020

Record last verified: 2020-10

Locations

US(1)