40
Participants
Start Date
April 25, 2023
Primary Completion Date
April 1, 2024
Study Completion Date
April 1, 2024
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."
Amsterdam UMC, Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER