Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes

Completed · Not applicable

Conditions studied: Hyperinsulinism, Diabetes, Pancreatic Diseases, Pancreatectomy; Hyperglycemia

In brief

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.

Key facts

Study ID

NCT03303196

Run by

Children's Hospital of Philadelphia

People needed

10

Starts

2018-04-09

Expected to finish

2019-09-30

Last updated by the study team

2020-10-27

Who can join

Age: 6 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

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.
• 2-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.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.