New Glucose Sensor Pediatric

The first generation Medtronic MiniMed Subcutaneous Glucose Sensor (Sof-Sensor) was
originally approved by the FDA for commercialization as part of the Continuous Glucose
Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a
microelectrode with a thin coating of glucose oxidase beneath several layers of
biocompatible membrane. This same sensor was used as part of subsequent continuous glucose
monitoring (CGM) systems, such as the Guardian REAL-Time and Paradigm REAL-Time sensor
augmented insulin pump. The current configuration of sensor has undergone in vitro and in
vivo testing. A new second-generation glucose sensor (herein referred to as the Comfort
Sensor) has been developed. The first-generation glucose sensor was approved with reported
sensor accuracy (MAD) of 18%; it was labeled for maximum use duration of 72 hours, using
only the abdomen as an insertion site. The new sensor is shorter and has a smaller diameter,
with a smaller gauge introducer needle. The new sensor inserter is designed to be used with
the new sensor. The objectives of this study are to 1) Assess performance of the Comfort
Sensor when used over a period of seven days with currently available devices, and 2) Assess
performance of the Comfort Sensor when used over a period of seven days using new
calibration algorithms (post-processed with algorithm for future devices). Accuracy data
will be calculated based on comparing calibrated glucose sensor values to glucose meter
values during in-home testing. The devices that will be used for gathering sensor data
during this study will be: 1) the Comfort Sensor, 2) the MiniLink (Transmitter), and 3) the
Guardian REAL-Time Display Device.