MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Study finds TRUE2go system
easy, convenient for patients
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
Good things sometimes do come in small packages – a
point that Home Diagnostics (Fort Lauderdale, Florida)
recently proved with the results of a clinical performance
study of its TRUE2go blood glucose monitoring system.
According to the company, the device is the world’s smallest
blood glucose meter.
The study, published in the October issue of the journal
Diabetes Technology & Therapeutics, demonstrated the
accuracy and precision of the True2go system and found
that it was both easy and convenient to use by patients, the
company said.
Sabrina Rios, a Home Diagnostics spokeswoman, told
Medical Device Daily that the TRUE2go is convenient for
diabetes patients to use because of its size. The device is
less than two inches long and about an inch and a half wide
– just a little bigger than a quarter – and screws on top of a
vial of test strips, Rios said. She said diabetes customers
say they like the monitor because it is “really easy to carry
in their purse or pocket.” The device is especially convenient
for athletes with diabetes, she said.
The TRUE2go monitor also works quickly, Rios noted,
producing results in about four seconds or less. The system
received FDA clearance last year (Medical Device Daily, Aug.
22, 2008).
According to the company, the purpose of the TRUE2go
study was to test the accuracy and precision of the
TRUE2go system and to evaluate whether lay people could
use the system as easily as healthcare professionals. The
study was also designed to assess lay users’ understanding
of and compliance with the TRUE2go system’s instructions
for use and to evaluate users’ satisfaction with the test system,
Home Diagnostics said.
“This study is significant in that it clearly proves that
True2go is a system designed with user convenience in
mind and instructions and features that make it easy for
people living with diabetes to consistently and accurately
self-monitor their blood glucose levels,” said Joe Capper,
president/CEO of Home Diagnostics. “As one of the best
predictors of good glycemic control and overall management
of diabetes, self monitoring is a critical element of living
well with diabetes.”
Rios also pointed out another advantage to the
TRUE2go system – cost. The system retails, on average, for
$9.99 for the meter with 10 test strips included. The
TRUEtest strips, which work with the TRUE2go monitor,
retail for about 70 cents a strip and overall people using the
system can save about $400 a year on their diabetes testing
supplies, she said.
“This study proves that the TRUE2go and meters like
ours . . . tend to be a lot less expensive than the national
brands but is as accurate,” Rios said.
Home Diagnostics said that as the number of people
with diabetes continues to grow around the world, it is
increasingly important to minimize the complications of
diabetes by encouraging the achievement and maintenance
of glycemic control. To help people with diabetes
control their blood glucose levels, manufacturers need to
develop products that are simple, easy to use and accurate,
the company said. The TRUE2go is a no-coding meter that
requires a small 0.5 microliter of blood.
Mark Kipnes, MD, Hal Joseph, Harry Morris, Jason
Manko, and Douglas Bell, PhD, authored the study. The
study found that 100% of glucose test results fell within ISOrecommended
limits for glucose concentrations ranging
from 24 mg/dl to 549 mg/dl.
Because of its convenience, Home Diagnostics says
that its TRUE2go system could improve compliance of testing
for people with diabetes.
(This story originally appeared in the Oct. 23, 2009 edition
of Medical Device Daily.)
65
To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912 outside the U.S. and Canada, call (404) 262-5547.
Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.