CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Bihormonal Bionic Pancreasdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03303196
NCT03303196N/ACompleted
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Bihormonal Bionic Pancreas for the Treatment of Diabetes Post-Pancreatectomy in Children With Congenital Hyperinsulinism - A Pilot Study

Children's Hospital of Philadelphia·interventional·Posted Oct 5, 2017·Updated Oct 27, 2020

In Brief

A clinical study evaluating Bihormonal Bionic Pancreas for Hyperinsulinism and 3 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperinsulinism, Diabetes, Pancreatic Diseases, Pancreatectomy; Hyperglycemia
CountriesUnited States
CollaboratorsBoston University, Massachusetts General Hospital

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 5, 2017
Enrollment StartApr 9, 2018
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.7 years ago

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.