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Diabetes, unless carefully monitored
and treated, has severe long-term medical complications.
Clinical studies have shown that tight glucose control
significantly improves long-term clinical outcomes.
The typical glucose-monitoring regimen for diabetes
patients involves piercing a finger to obtain a blood
sample, which is generally collected on a test strip
and then analyzed in a suitable device. The current
standard of care recommends that this procedure be repeated
a minimum of four times per day. Because of the uncomfortable,
cumbersome nature of this test regimen, compliance is
poor.
SMSI® is developing
a new approach to glucose monitoring that we believe
will be an improvement over existing methods. SMSI's
glucose sensor, (pictured above, right and below, left)
will be implanted under the skin in a short outpatient
procedure. The sensor is designed to automatically measure
interstitial glucose every few minutes, without any
user intervention. The sensor implant will communicate
wirelessly with a small external reader (pictured above,
left), allowing the user to monitor glucose levels continuously
or on demand. The reader is designed to be able to track
the rate of change of glucose levels and warn the user
of impending hypo- or hyperglycemia. The target operational
life of the sensor implant will be 6-12 months, after
which it would be replaced.
We believe that diabetes patients
will perceive this system to be an improvement in glucose
monitoring. Our clinical trials will be designed to
demonstrate that this system is accurate enough to replace
standard home blood glucose monitoring. With positive
results from our initial clinical studies, supplemental
clinical studies would be designed to demonstrate that
the quality and quantity of glucose data provided by
the SMSI system enables patients to control their diabetes
more effectively. SMSI expects this will translate into
significant adoption rates and improved patient health.
CAUTION - Investigational
device. Limited by federal law to investigational use.
The availability of any product in the United States
developed from these technologies is dependent on FDA
marketing approval. Availability in other countries
is subject to additional regulatory approvals.
Copyright © 2010 Sensors for Medicine and Science, Inc.®
All rights reserved. Date of last update: 02/03/10.
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