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Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes

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ClinicalTrials.gov Identifier: NCT03303196
Recruitment Status : Active, not recruiting
First Posted : October 5, 2017
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
Boston University
Massachusetts General Hospital
Information provided by (Responsible Party):
Diva De Leon, Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Hyperinsulinism Diabetes Pancreatic Diseases Pancreatectomy; Hyperglycemia Device: Bihormonal Bionic Pancreas Not Applicable

Detailed Description:

The management of diabetes following pancreatectomy for hyperinsulinism (HI) generally consists of the same approaches that are used for individuals with type 1 diabetes (T1D). However, there are significant differences in individuals with HI and post-pancreatectomy diabetes that increases the risk of hypoglycemia in these individuals and prevent achieving tight glycemic control. Individuals with HI have glucagon deficiency and unlike T1D, those with HI and post-pancreatectomy diabetes have residual dysregulated insulin secretion that results in marked hypo- and hyper-glycemia. Furthermore, pancreatic insufficiency can result in disturbances in nutrient absorption and fluctuations in glucose concentrations.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bihormonal Bionic Pancreas for the Treatment of Diabetes Post-Pancreatectomy in Children With Congenital Hyperinsulinism - A Pilot Study
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: 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.
Device: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Mean plasma glucose level. [ Time Frame: Days 2-3 of each admission ]
    Mean plasma glucose concentration, as measured by the Continuous glucose monitoring system (CGMS), during the final 3 days of the Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.

  2. Mean proportion of hypoglycemia. [ Time Frame: Days 2-3 of each admission ]
    Mean proportion of time that the CGMS-measured plasma glucose concentration was less than 60 mg/dL during Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.


Secondary Outcome Measures :
  1. Mean CGMS-defined plasma glucose level. [ Time Frame: Days 2-3 of each admission ]
    Average plasma glucose level as measured by the CGMS during Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.

  2. Time spent in pre-defined glucose ranges. [ Time Frame: Days 2-3 of each admission ]

    Fraction of time spent within each of the following glucose ranges:

    • < 50 mg/dL
    • < 60 mg/dL
    • < 70 mg/dL
    • 70-120 mg/dL
    • 70-180 mg/dL
    • >180 mg/dL and
    • >250 mg/dL.

  3. Percentage of non-hyperglycemic subjects. [ Time Frame: Days 2-3 of each admission ]
    Percentage of subjects with mean CGMS < 154 mg/dL (estimated average glucose corresponding to an A1c of 7%).

  4. Percentage of hypoglycemic episodes among subjects. [ Time Frame: Days 2-3 of each admission ]
    Percentage of schedule fingerstick checks < 70 mg/dL, < 60 mg/dL, <50 mg/dL.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females age 6 to 30 years.
  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:

  1. Unable to provide informed consent (e.g. impaired cognition or judgment).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303196


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Boston University
Massachusetts General Hospital
Investigators
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Principal Investigator: Diva D De Leon, MD, MSCE Children's Hospital of Philadelphia
Principal Investigator: Arpana Rayannavar, MD Children's Hospital of Philadelphia

Additional Information:
Publications:

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Responsible Party: Diva De Leon, Director, Congenital Hyperinsulinism Center, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03303196     History of Changes
Other Study ID Numbers: 17-014144
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Diva De Leon, Children's Hospital of Philadelphia:
Post-Pancreatectomy Diabetes
Insulin Therapy
Additional relevant MeSH terms:
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Hyperinsulinism
Pancreatic Diseases
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents