Noninvasive blood glucose monitor compares favorably to fingersticks in diabetes
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Key takeaways:
- A noninvasive blood glucose monitor measured glucose with an accuracy similar to fingersticks.
- This noninvasive device may be able to detect hypoglycemia quicker than current continuous glucose monitoring.
SAN DIEGO — A novel noninvasive blood glucose monitor may be able to measure glucose levels with an accuracy similar to fingersticks, according to a presenter.
The GWave blood glucose monitor (Hagar) uses radiofrequency waves to noninvasively measure venous blood glucose concentrations while filtering out white noise. The device measures glucose in the venous blood as opposed to CGMs, which measure glucose within interstitial fluid. In findings 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 lag time observed with current continuous glucose monitoring devices, according to data presented at the American Diabetes Association Scientific Sessions.
“My prediction is ... we are going to see how primitive our current CGM is compared with what we’re going to see in the future [with noninvasive blood glucose monitoring],” Irl B. Hirsch, MD, professor of medicine at University of Washington School of Medicine in Seattle, told Healio.
Hirsch and colleagues conducted noninvasive blood glucose monitoring with 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 years or younger. After GWave measurements were taken, participants had three blood samples collected with a fingerstick. The average of the three fingerstick tests was calculated as the comparator for the GWave results. People with diabetes who used a personal CGM also had their readouts compared with those from GWave. Glucose measurements were plotted using a Clarke error grid. Mean absolute relative difference was calculated to determine the accuracy of GWave monitoring compared with fingersticks.
Of the GWave measurements collected, 97% were in Clarke error grid zone A, which is defined as clinically accurate. The mean absolute relative difference between GWave blood glucose monitoring and the fingerstick 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 at a similar level to fingerstick measurements under insulin-induced hypoglycemia, whereas both CGM devices measured higher glucose levels than the noninvasive device and fingersticks up until 90 minutes after insulin-induced hypoglycemia began. Additionally, in a comparison of the GWave monitor with measurements from a 75 g oral glucose tolerance test, the noninvasive device showed a glucose spike at the same rate as what was measured through venous glucose.
Hirsch said it is difficult to pinpoint when the noninvasive blood glucose monitoring device could become available commercially due to the novelty of the device.
“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 not invasive, the fact that because it’s measuring blood there’s no lag when you have glucose levels going down. ... there’s all these advantages.”
Hirsch noted the data presented at the conference went up to glucose levels of only 180 mg/dL. He said more studies are needed examining hypoglycemia as well as increases and decreases in glucose levels.
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Hirsch IB, et al. 130-LB. Presented at: American Diabetes Association Scientific Sessions; June 23-26, 2023; San Diego (hybrid meeting).
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