NCT03303196

Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes

Bihormonal Bionic Pancreas for the Treatment of Diabetes Post-Pancreatectomy in Children With Congenital Hyperinsulinism - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 6 Years – 30 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hyperinsulinism
• Diabetes
• Pancreatic Diseases
• Pancreatectomy; Hyperglycemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-09
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2017-10-05
• Last updated: 2020-10-27
• Results posted: 2020-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study