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 ISO-recommended 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.

Amanda Pedersen; 229-471-4212