The short answer is, we don’t know for sure. But a company that’s wrapped up initial testing of its bloodless glucometer and closed a series B round of financing thinks it has a good shot at becoming the “first noninvasive technology with a real shot at diagnostic accuracy,” in the words of its CEO.
Grove Instruments’ Optical Bridge technology uses near-infrared spectroscopy to measure a person’s real-time blood sugar in less than 20 seconds. The company’s first product is an accessory-free, battery-operated personal glucose meter used on the fingertip or earlobe.
Grove is one of several companies working on a noninvasive diabetes test using spectroscopy including DIRAmed, C8 MediSensors and InLight Solutions. Challenges in developing devices using this technique have included water interference and low signal-to-noise ratio, but Grove thinks it has developed solutions to these problems.
“Yes, we work in near-infrared spectroscopy space, but our methodology and our particular construct is unique within the space,” said CEO Arthur Combs. “We have strong validation that we have unique technology.”
That validation has come in the form of funding through 10 SBIR grants awarded by the NIDDK NIH and a loan from the Massachusetts Life Sciences Center Accelerator Program, Combs said.
It’s also come in the form of results from a large study conducted last fall to test the device’s measurements against standard blood glucose determination. The company collected nearly 4,000 data pairs; the results, which are pending publication, indicate that the device was able to meet the ISO 15197 standard for accuracy, Combs said.
Over the past few decades, diabetes researchers have studied with varied success a number of noninvasive ways to measure glucose including the use of saliva, breath and the watery substance at the front of the eye. Other companies currently developing or awaiting approval on noninvasive diabetes testing devices include the Israeli company Integrity Applications — which is anticipating approval in 2013, Echo Therapeutics and OrSense.
Research has demonstrated that self-monitoring of blood glucose has been associated with better glycemic control in type 1 diabetics and can improve health outcomes. “We’re not doing this just because people are babies and won’t stick their finger,” Combs said, adding that barriers to adherence of regular blood glucose testing include pain, blood aversion, complicated testing methods, embarrassment and cost. “Everybody has their own reasons why they don’t test. Our opportunity is to get everyone to benefit.”
The U.S. market for glucose monitoring, currently dominated by Johnson & Johnson, Abbott Laboratories, Roche, Bayer AG and Medtronic, was forecast by the Medtech Insight division of Elsevier Business Intelligence to reach $4 billion by next year.
Formerly known as VivaScan Corp., Grove has been developing this technology for several years. Earlier this year it raised a $2.4 million series B. Its pipeline also includes a professional glucometer for use by providers in screening for diabetes and prediabetes, and a continuous glucose monitor that could be part of the coveted artificial pancreas, according to its website.
[Photo from Grove Instruments]