Would
your patients test their blood glucosemore often if it were painless and convenient?
Dozens
of companies are betting that millions of people with diabetes will answer
yes. The race to be the first to market non-invasive blood glucose systems is
nearing an end.
The
companies use a variety of technologies. But the choice of technology matters
less than whether it works.
It's
such a high-stakes race and a couple of companies have technologies that
promise to deliver painless blood glucose testing. Yet, some of these are so
thinly capitalized that they stand little chance of finishing the race.
What’s
the rush to market? U.S. expenditures for blood glucose meters and supplies
will be about $1 Billion this year
Photo illustration of the
SugarTrac™Non-Invasive Glucose Monitor prototype model for home use
A
non-invasive blood glucose monitor might help many more people with diabetes
get their blood glucose under better control by testing more frequently.
That's especially true for meters that promise to measure glucose levels
continuously. The payoff of better control is fewer complications, according
to the 1993 DCCT Trial.
One
of the companies we have been watching is LifeTrac Systems. The methodology of
the technology is based upon the following parameters: Light frequency,
pulse, volume of blood, signal generation and a
number
of multi algorithms.
It
has been in development for a number of years.Last week I had a chance to talk to William Danton, CEO of LifeTrac.Bill shared with me some interesting news about his company that I
would like to share with you.
The
first unit produced was about the size of a table and was not very accurate.But over the last 5 years, it has been refined and improved.
The
Sugar-Trac monitor passed a major test when LifeTrac released the first
verified results from the ongoing clinical trials at Brigham Women’s
Hospital in Cambridge, MA., a Harvard University teaching hospital.
The
SugarTrac™ Non-Invasive Glucose Monitor revealed a correlation of 0.88
compared to a LifeScan OneTouch Ultra (fingerstick monitor) and a Beckman.
CEO
William Danton said, "This independent verification is exactly what we
had hoped for." "Our own studies showed similar results as far back
as 1998, and with our new and much smaller monitor, we are now only months
away from delivering a more robust unit that will be ready for FDA
approval." Dr. Williams noted a small problem with overheating after
repeated measures over time and very cold skin temperatures, but was confident
that a 'more robust unit would likely resolve these problems, leading to even
more accurate measures."
By
comparison, the FDA requires a typical finger-stick monitor to only be 75%
accurate with a 20% +/- variation, when used by a diabetes patient to monitor
their glucose.
What
will the final SugarTrac™ Non-invasive Glucose Monitor look like when it is
ready to be submitted for FDA approval? According to CEO Bill Danton, we may
only be a few short months away from finding out. "The firm we are
talking to is very enthusiastic about the SugarTrac™ and wholeheartedly
believe they can further our miniaturization of the monitor, allowing us to
deliver a unit that is about the size of a pager." stated Danton.
"And remember, this is a device that only two years ago was the size of a
coffee table."
For
the first phase, the unit will still be a tethered device, with an adjustable
earpiece designed to measure a diabetics glucose level by using NIR or
near-infrared light. Future iterations of the device will be in 4
introductions.
Phase
2 will be a wireless unit.Phase
3 will be the addition of alarms to monitor high and low blood sugars.
Phase
4 will offer continuous monitoring of a patients glucose levels, for more
active management of the deadly disease.
Then
Phase 5 will be paired up with an insulin pump to make a continuous loop,
which, will be monitoring and injecting insulin automatically, likes an
artificial pancreas.
The
next study at Harvard will be a double blind study using the new device for 40
patients.Expected start date in
2 or 3 months.
Whereas
the SugarTrac™ device is non-invasive, in addition to other factors, it is
anticipated that the actual FDA approved trials will last from three to four
months, being completed by June or July of 2003. Add approximately three
months for the FDA approval process and the SugarTrac™ Noninvasive Glucose
Monitor could be approved by September or October of 2003.
As
far as financing goes, theyraised
$1.3 million dollars in investment capital last year, this will take them
through the study at Harvard. The unit is also being tested at 4 US locations
and in Switzerland.
If
and when it reaches the market it will probably cost about 50 dollars a month
for 150 readings about 30 cents a reading, which is about ½ of what strips
now cost.
Bill
mentioned that he would like to possibly use subscribers from Diabetes In
Control to run future surveys to get your response, so stay tuned.
Above
photos are only possible scenarios of what the final unit might look like and
do not represent the actual product.
