The purpose of this study is to assess performance of a new subcutaneous glucose sensor over a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance of the new sensor will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
83
All subjects to wear sensors
University of Alabama Birmingham
Birmingham, Alabama, United States
Sutter Institute for Medical Research
Sacramento, California, United States
Endocrinology/ University of South Florida
St. Petersburg, Florida, United States
University of Minnesota Amplatz Children's Hospital
Minneapolis, Minnesota, United States
Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use]
The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and SMBG glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between SMBG and paired sensor (within 20 mg/dL if SMBG ≤ 80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.
Time frame: Days one through six of sensor use
Device Related Moderate or Device Related Severe Adverse Events
Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy. Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device
Time frame: days one through six of sensor wear
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