Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03303196
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : October 24, 2019
Sponsor:
Collaborators:
Boston University
Massachusetts General Hospital
Information provided by (Responsible Party):
Diva De Leon, Children's Hospital of Philadelphia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Diva D De Leon, MD, MSCE Children's Hospital of Philadelphia
Principal Investigator: Arpana Rayannavar, MD Children's Hospital of Philadelphia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Children's Hospital of Philadelphia | Congenital Hyperinsulinism Center Website  This link exits the ClinicalTrials.gov site Boston University | Bionic Pancreas Website  This link exits the ClinicalTrials.gov site

Publications:

Layout table for additonal information
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: October 24, 2019
Last Verified: October 2019

Layout table for additional information
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:
Layout table for MeSH terms
Pancreatic Diseases
Diabetes Mellitus
Hyperglycemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents