Helga Blauw, Netherlands
Amsterdam UMC EndocrinologyPresenter of 1 Presentation
CLINICAL VALIDATION OF A BIHORMONAL ARTIFICIAL PANCREAS
Abstract
Background and Aims
A prototype of our integrated and fully automated bihormonal artificial pancreas was successfully tested in a pilot study at home. Subsequently, a product version was developed and locked for CE-mark registration. The aim of this pivotal CE mark trial was to assess the performance and safety of this artificial pancreas.
Methods
Twenty-three adult patients with type 1 diabetes completed this randomized open cross-over study during daily life at home. Two weeks of closed loop glucose control with the artificial pancreas (Figure) were compared with two weeks of insulin pump therapy with Flash Glucose Monitoring (n=12), Predictive Low Glucose Suspend (n=5) or SMBG (n=6) and blinded CGM for data collection. A training period of four days preceded the closed loop period.
Results
The median [IQR] time in range (3.9-10 mmol/l) was higher during closed loop (86.6 [84.9-88.3]%) compared to the control treatment (53.9 [49.7-67.2]%, p<.001). The median glucose level decreased from 9.3 [8.3-9.9] mmol/l to 7.2 [7.0-7.4] mmol/l with the artificial pancreas (p<.001). Time in hypoglycemia was 2.0 [0.7-3.6 ]% during control treatment and 0.4 [0.1-0.8]% with the artificial pancreas (p<.001). No severe hypoglycemia or ketoacidosis occurred during the study.
Conclusions
This study demonstrates that our bihormonal artificial pancreas provides better glucose control than standard open loop therapy in adult patients with type 1 diabetes. The artificial pancreas met the predefined performance and safety requirements for the clinical validation and therefore we expect that the system will receive a CE-mark in 2020.