Non-invasive blood glucose monitor compares favorably to fingersticks in diabetics

Key points to remember:

• A non-invasive blood glucose monitor measured glucose with finger-like accuracy.
• This non-invasive device may be able to detect hypoglycemia more quickly than current continuous glucose monitoring.

SAN DIEGO—A Novel non-invasive glucometer may be able to measure glucose levels with finger-like accuracy, according to a presenter.

The GWave Blood Glucose Monitor (Hagar) uses radio frequency waves to noninvasively measure venous blood glucose concentrations while filtering out white noise. The device measures glucose in venous blood as opposed to CGMs, which measure glucose in interstitial fluid. In results from a version of the GWave using a second-generation chip, the device detected glucose levels similar to an oral glucose tolerance test and was able to identify insulin-induced hypoglycemia without the time to latency seen with current continuous glucose monitoring devices, according to data presented at the American Diabetes Association Scientific Sessions.

“My prediction is…we’re going to see how primitive our current CGM is compared to what we’re going to see in the future [with noninvasive blood glucose monitoring]”, Irl B. Hirsch, MD, professor of medicine at the University of Washington School of Medicine in Seattle, Healio said.

Hirsch and colleagues performed noninvasive blood glucose monitoring on 75 study participants, of whom 28 had type 1 diabetes, six had type 2 diabetes, 10 were pregnant women with diabetes, and 31 were people without diabetes. Five of the participants were aged 15 or younger. After the GWave measurements were taken, the participants had three blood samples taken with a finger. The average of the three finger tests was calculated as a comparator of the GWave results. People with diabetes who used a personal CGM also had their readings compared to those of GWave. Glucose measurements were plotted using a Clarke error grid. The mean absolute relative difference was calculated to determine the accuracy of GWave monitoring compared to fingers.

Of the GWave measurements collected, 97% fell within Zone A of the Clarke error grid, which is defined as clinically accurate. The mean absolute relative difference between GWave blood glucose monitoring and fingertip blood glucose values ​​was 6.7%.

In a comparison between glucose levels measured with the GWave and two CGM devices, the noninvasive meter measured blood glucose levels similar to fingerstick measurements under insulin-induced hypoglycemia, while both CGM devices measured higher glucose levels than noninvasive device and fingers up to 90 minutes after onset of insulin-induced hypoglycemia. Additionally, in a comparison of the GWave monitor with measurements from a 75g oral glucose tolerance test, the noninvasive device showed a spike in glucose at the same rate as that measured by venous glucose.

Hirsch said it was difficult to determine when the noninvasive blood glucose monitoring device might become commercially available due to the novelty of the device.

“The FDA has never seen anything like this before,” Hirsch said. “You can’t predict what kind of questions they’re going to ask – that’s number one. But I think the fact that it measures blood, not interstitial glucose, the fact that it’s non-invasive, the fact that because it’s measuring blood, there’s no lag when blood sugar goes down. … there’s all of those benefits.

Hirsch noted that the data presented at the conference went up to glucose levels of just 180 mg/dL. He said more studies were needed to look at hypoglycaemia as well as increases and decreases in glucose levels.

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American Diabetes Association Scientific Sessions