Presenter of 1 Presentation
NOVEL APPROACH OF DAY-1 PERFORMANCE IMPROVEMENT OF AN AMPEROMETRIC GLUCOSE SENSOR BY ACCELERATING SENSOR READINESS DURING WARM-UP PERIOD
Abstract
Background and Aims
WaveForm has commercialized the Cascade CGM, an electrochemical, trocar-less CGM system for people with diabetes. Accelerating sensor readiness during the initial warm-up phase and up to 48 hours has been recognized as important aspect of improving the performance of the amperometric sensor on day 1. The feasibility of using a specific voltage modulation pattern over the initial warm-up period was assessed in non-diabetic animal model (porcine) and humans.
Methods
Several sensors were inserted in anesthetized Yucatan-mini pigs. During the initial warm-up phase of 60 minutes the bias voltage was modulated. Then after a consistent current was obtained, the system was operated at s steady state bias potential. After about 3 hours the glucose level was elevated by infusion of saline containing 20% dextrose. Blood glucose samples by ear prick were taken every 10 min for a total of 4 hours. The current response of sensors with and without bias modulation was compared. Sensor accuracy was retrospectively assessed. Initial assessment of this approach was performed in a human study.
Results
In animals MARD was significantly improved during the initial 4 hours in sensors being conditioning by bias modulation (11.7%) over sensors treated with steady-bias voltage at 650 mV (19.5%, p<<0.05). Preliminary MARD of 12.5% observed in sensors with bias modulation worn by human subjects over 48 hours confirmed this result.
Conclusions
The feasibility of specific bias modulation during warm-up time of an amperometric sensor was demonstrated. We will report on the results from a currently ongoing clinical trial in humans with diabetes at the meeting.