Ellis asks:
Does anybody know if there is a blood glucose monitoring
meter that is accurate and does not require blood or urine?
[Hello Eugene... thanks for sending us this... It looks like
there will be a blood glucose monitoring meter that is
accurate and does not require blood, after all, if it can
get F.D.A. approval (and why shouldn't it?) This report
is only a few days old, too... - Ellis]
Here's one idea:
Relief From Pin-Pricking May Be at Hand
By Sam Jaffe June 2, 2005
Diabetes is a complex disease with complex causes and
complex treatment regimens. In the end, though, it comes
down to this: to stay well, a person with Diabetes A has
to draw blood four times a day.
"It's painful and it's stressful," says Matt Petersen, the
director of information services in the American Diabetes
Association's Medical and Science Division. "If anyone can
come up with a cost-effective, safe, non-invasive way to
measure glucose, I can't imagine the world not beating a
path to their door."
Ron Nagar and Benny Pesach, the founders of Glucon, Inc.,
have created a watch-like device that reads blood glucose
levels without the need to stick, poke, or prick the skin.
Based on photo-acoustics research first done at Tel Aviv
University in Israel, their device uses lasers,
ultrasound, and advanced software algorithms to get a
reading that is as efficient and accurate as pin-prick
tests. And, says Glucon's CEO, Dan Goldberger, it won't be
any more costly than testing kits, which today average
between $1,500 and $2,000 per year for a patient.
At the heart of the Glucon device is a laser tuned to a
frequency that resonates with blood glucose. When the
laser comes into contact with blood glucose, it creates
sound waves emanating from the molecule. Then a
miniaturized ultrasound sensor detects those sound waves
and a computer chip translates the raw signals into usable
data. The device is worn like a wristwatch. Data and
warning signals -- say, "Sudden glucose drop" -- would
appear on the faceplate of the device.
While other non-invasive technologies have been able to
read glucose levels to a rough level, Glucon's early tests
show that it reaches the same efficiency levels as blood-
strip tests. The only one of Glucon's tests to have been
published was a four-hour measurement of nine diabetic
patients done in 2002 with an earlier prototype. The
results were compared to traditional pinprick tests and
matched them well. Goldberger points out that since that
paper was published, his researchers have made big strides
in improving the device's efficacy even further, although
he won't release specific numbers.
Before they release numbers to the public, they must
obtain Food and Drug Administration approval -- a process
that can take years. Because of the non-invasive nature of
the technology, though, Glucon's regulatory process is
much less arduous than for implantable or skin-puncture
medical devices.
If Glucon succeeds in getting FDA approval, its device
could revolutionize diabetes management for both the
individual patient and the health-care industry. Of the 18
million diabetics in the United States, roughly three
million need constant surveillance to prevent extreme
hypoglycemic events. Yet more than half of those three
million make mistakes on a regular basis in glucose
monitoring or insulin administration, errors that can lead
to insulin shock and a diabetic coma. Having a 24-hour,
real-time readout of glucose levels in the blood would
ensure that the patient always knows exactly his or her
glucose level. What's more, later generations of the
device could wirelessly transmit the data to a doctor's
office or central database.
It's not just the diabetic patients who are excited about
the prospect. Health insurance companies would be willing
to pay a premium for such a device if it keeps down the
costs of emergency-room visits and long-term health
crises, such as diabetic blindness, says the ADA's
Petersen.
Glucon Inc. isn't alone in its efforts to develop a better
glucose monitoring system. More than a dozen startups and
academic labs are working on competing technologies. But
none of them has a working prototype on the verge of
clinical studies that is both non-invasive and offers the
ability to monitor constantly.
Glucon's most likely competitor is medical-device giant
Medtronic (a company that's a member of the TR Large Cap
100 Index in the health-care sector). Medtronic's core
strength in the diabetes market is an insulin pump that
offers a less painful and less intrusive way to disburse
insulin into the body, compared with direct injections.
The company is also in clinical trials for a sensor that
measures blood glucose indirectly by reading marker
chemicals in the interstitial fluid (located a fraction of
a millimeter below the skin's surface).
"You can barely feel the pin prick," says Medtronic
spokesperson Deanne McLaughlin. Yet because it involves
puncturing the skin, the device has to overcome many more
regulatory hurdles than Glucon's device.
Goldberger understands the challenges his tiny company,
with 20 fulltime employees, is facing -- namely, the lack
of a manufacturing base, easy access to capital, and a
distribution network. A large pharmaceutical company
partner would solve these problems. And the company
recently added Ephraim Heller to its board of directors,
the man who built his diabetes management startup
TheraSense into an international firm that generated
hundreds of millions of dollars in revenue before being
bought out in 2004 by Abbott Laboratories.
"It's not impossible to recreate the TheraSense model,"
Goldberger says, adding that the company could build its
own manufacturing, distribution, and sales channels.
Meanwhile, Glucon has a clinical trial underway, with
others set to launch soon, to prove the accuracy of their
device to regulators. Goldberger hopes to see Glucon
"watches" on the arms of diabetics within three years.