Authors:
O'Grady, M. J.; Retterath, A. J.; Keenan, D. B.; Kurtz, N.; Cantwell, M.; Spital, G.; Kremliovsky, M. N.; Roy, A.; Davis, E. A.; Jones, T. W.; Ly, T. T.
Authors notes:
Diabetes Care. 2012;35(11):2182-7
Keywords:
artificial pancreas system, outpatient, patient safety, closed-loop system, home studies, Medtronic Portable Glucose Control System (PGCS), glucose sensors, insulin pump, type 1 diabetes
Abstract:
A key milestone in progress towards providing an efficacious and safe closed-loop artificial pancreas system for outpatient use is the development of fully automated, portable devices with fault detection capabilities to ensure patient safety.
The ability to remotely monitor the operation of the closed-loop system would facilitate future physician-supervised home studies.
This study was designed to investigate the ef ficacy and safety of a fully automated, portable, closed-loop system. The Medtronic Portable Glucose Control System (PGCS) consists of two subcutaneous glucose sensors, a control algorithm based on proportional- integral-derivative with insulin feedback operating from a Black-Berry Storm smartphone platform, Bluetooth radiofrequency translator, and an off-the-shelf Medtronic Paradigm Veo insulin pump.
Participants with type 1 diabetes using insulin pump therapy underwent two consecutive nights of in-clinic, overnight, closed-loop control after a baseline open-loop assessment.
Eight participants attended for 16 overnight studies. The PGCS maintained mean overnight plasma glucose levels of 6.4 ± 1.7 mmol/L (115 ± 31 mg/dL). The proportion of time with venous plasma glucose <3.9, between 3.9 and 8 (70 and 144 mg/dL), and >8 mmol/L was 7, 78, and 15%, respectively.
The proportion of time the sensor glucose values were maintained between 3.9 and 8 mmol/L was greater for closed-loop than open-loop (84.5 vs. 46.7%; P < 0.0001), and time spent <3.3 mmol/L was also reduced (0.9 vs. 3%; P < 0.0001).
These results suggest that the PGCS, an automated closed-loop device, is safe and effective in achieving overnight glucose control in patients with type 1 diabetes.