Diabetes
In Control interviews the CEO of the first company to bring a Non-Invasive
Blood Glucose Monitor to clinical trials
Dave Joffe, Editor
in Chief
I had the unique opportunity to spend time with William Danton.,
CEO of LifeTrack Systems, Inc.
Mr. Danton announced that a "Clinical Trial Protocol"
has been approved by the Institutional Review Board of the Brigham
& Women’s Hospital an affiliate of Harvard Medical School in
Boston, Massachusetts. Dr. Ronald A. Arky, M.D., Chief, Section of
Diabetes & Metabolism at Brigham & Women’s Hospital will
participate in the "Clinical Trial Protocol" as
Principle Investigator. This study will include approximately 40
persons with diabetes.
The "Clinical Trial"
will test the accuracy and consistency of LifeTrac Systems Inc’s
SugarTrac® Non-Invasive Glucose Monitor". 
The
double-blind "Clinical Trial" study will be begin
February 2002 at Brigham & Women’s Hospital on a
representative cross section study group of people with diabetes.
Most of the Patients will be insulin dependent and had been
testing an average of 3 to 5 times a day. The SugarTrac® Results
can be obtained anytime, as often as the user desires.
SugarTrac® is a unique
Non-Invasive Glucose Monitoring device, which is portable and
hassle-free. The cell phone sized monitoring device is powered by
a 9v battery and offers a pain-free, blood-free method of testing
an individual’s glucose level non-invasively. The Sugar Trac
uses infrared photons sent directly through the earlobe to a
sensor and through patented software calculations the glucose
level is displayed.
The product has been in
development for 6 years and when Mr. Danton was introduced to the
product he put together a group of private investors to fund the
continued development. They currently have about 20 employees and
they anticipate bringing this to market about 1 year after the
pilot project is finished. Since there is no blood required it
will not need to be CLIA waved, and will be able to be used in the
office as well as for home use. There appears to be no
interference based on skin pigmentation. There also appears to be
no lag time problems with extreme highs or lows. This is reported
to have been a sticking point and has been a problem for the
Glucowatch and alternate site meters.
We know that there are other
devices on the market that use light waves to measure blood
glucose and they have all had problems getting FDA approval. Mr.
Danton indicated the difference is in the length of the light wave
they use and the software they have developed. Previous use by
various medical professionals, have shown the unit to be
consistently within 5% of glucose
monitors and the trial at Brigham & Women’s Hospital will
compare the Sugar Trac to the
readings of a Beckman unit. Mr. Danton commented that the expected
range will be less than 5%.
For the diabetes patient and the
insurance company this is a real winner as the only costs are the
unit and the replacement batteries, there are no other supplies
necessary. Anticipated costs are about 1.50 to 2 dollars a day
In addition the unit will be
capable of storing all the readings and this information can be
downloaded to a laptop or computer in the office or home and then
the results can be printed for review.
LifeTrac Systems, Inc.
develops
applications for its patented technology to track various marker
enzymes of blood transported diseases "non-invasively".
The Company is currently private and its shareholders are various
U.S., Canadian and European Venture Capital Groups.
Next week we hope to have an
interview with the physician who will be in charge of the clinic
program.
View
The "New Product" Archives
