CGMS UPDATE: New Products
The Guardian CGMS- Medtronic Minimed
The Guardian
Continuous Glucose Monitoring System
includes three components:
1. A sensor that is inserted just under the skin. It records glucose
levels using fluid from the layer of fat between your skin and muscle
(called “interstitial fluid”). Once inserted, the sensor
is virtually painless and easy to wear –– even for children.
The sensor is designed to be worn up to three days. To calibrate the
sensor, you must enter glucose readings from a traditional (“fingerstick”)
monitor at least twice each day.
2. The system’s transmitter receives blood glucose readings from
the sensor. It then relays this information to a monitor using radio
waves. The transmitter can be worn discreetly under clothing. It is
not implanted into the body.
3. The monitor can be worn on your belt, or placed in a pocket or a
purse, as long as it is within 6 feet of the transmitter to be able
to receive signals. It’s about the size of a pager. The monitor
records glucose readings received from the sensor (via the transmitter).
The monitor is designed to sound an alarm if
you or your family member’s glucose readings fall out of range.
You or your healthcare provider will pre-set the monitor with your desired
glucose ranges prior to use. For example, if you set a low target of
70 mg/dL and a high target of 200 mg/dL, the monitor is designed to
alert you when it detects a reading outside of your low and high targets.
Note: The Guardian system is not intended to
replace fingersticks. At a minimum, the Guardian system must be calibrated
using a home glucose meter at least every 12 hours. Additional
calibrations will result in better system performance. Low or high glucose
alerts from the Guardian system should be verified using a home glucose
meter before taking any action.
4. The downloading system, which includes software and hardware, allows
you to download all of the glucose values that have been stored in the
monitor to a PC. The software then graphs these values so that you can
view trends in your blood glucose control and make informed decisions
about your therapy.
Guardian is not yet available for sale, according to
MiniMed and the introductory price for the system will be $999; this
does NOT include sensors which are sold separately for $350 for a box
of 10), potential market
Navigator
System-- Therasense (Abbott):
A wireless system which may not require calibration with finger sticks
or the use of a BGM.
Therasense (NASDAQ:THER) is awaiting FDA approval for their Navigator
system. The Navigator provides 60 readings per hour. Also under development
are systems that provide 120 to 240 readings per hour.
With the exception of the Navigator system, the majority of systems
under development are designed as a supplement to, and not a replacement
for, conventional glucose monitoring.
This means that patients must confirm readings provided by the system
with a conventional finger stick reading
