Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 25, 2023

Primary Completion Date

April 1, 2024

Study Completion Date

April 1, 2024

Conditions
Pancreatic NeoplasmsType 3c DiabetesTotal Pancreatectomy
Interventions
DEVICE

Bihormonal artificial pancreas (BIHAP) / closed loop

"The investigational device is a dual-hormonal fully closed loop system (BIHAP; industrial name AP® 5, Inreda Diabetic B.V.) which aims at optimally controlling plasma glucose levels. This BIHAP contains of two pumps for subcutaneous infusion of either insulin (Humalog, 3 ml pre-fill cartridge, Eli Lilly) or glucagon (GlucaGen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) via an infusion set (Accu-Chek Insight Flex or AccuChek Flex Link, Roche), two subcutaneously placed glucose-sensors (Guardian, Medtronic) and an algorithm driving pump infusion rates based on the sensor input. Daily self-measurements of blood glucose (SMBGs; Accu-Chek Instant, Roche) are needed for calibration of the glucose sensors.~The BIHAP-system has to be worn continuously, except while showering."

Trial Locations (1)

1081 HV

Amsterdam UMC, Amsterdam

All Listed Sponsors
lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER