SugarBEAT - finally needle-free?

Has anyone heard of this?

It seems really promising. No insertions of any kind, just a patch attached to the skin. It only requires a finger-prick once when you replace the patch. It seems like a real breakthrough, and is scheduled to be released in Europe by the end of the year.

How does accuracy compare to other methods? Is there any data (not theoretical but empirical)?

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@David_dns
That’s a good question and one of the reasons I posted about it here as this link is the only piece of information I currently have. I was wondering if anyone here might have some more data to share.

This seems too good to be true. If it works and if it’s accurate and if it becomes available in the US, it would be wonderful. How nice it would be to just look at a watch and read my blood sugar.

Madison

You can do this right now in the U.S. with the Dexcom CGM and an Apple Watch…

I looked at the website and it looks legit, but it is not projected to be available until the end of this year in Europe. There were no references to any clinical trial data, a flag in my book. I would like to know the “mean absolute relative difference” number or MARD, a measure of accuracy. The current Dexcom CGM is under 10% in a system where lower is better.

I hope it’s not hype but I resent marketing tease without some semblance of science foundation. I hope it works out and until then, we’ll see …

Agree with the above 100%. I also could find no trial data and no MARD. Which leads me to believe that Dexcom’s MARD is superior…

Not only that, but “Marketing Opportunities” is listed under the Technology dropdown. Hmmmmm.

Hmmmmm indeed!

Interesting. Reports of clinical trials can be seen on their News page, including a MARD of 11.8% reported in a 2015 clinical trial. Looks promising and legit.

The Dexcom G5 CGM system’s MARD is under 10%, which beats (pun intended) the SugarBEAT’s 11.8% MARD. Just sayin’…

We are still waiting for the Freestyle Libre which won European approval (the CE mark) in fall 2014. The FDA is still working on approving this and approval is hoped for in 2016. While this product may seem wonderful, it is still preliminary, may never be approved or make it to the market and it is unlikely to be available in US until 2018 or later.

These products are important for those of us with T2 as we are generally denied CGM technology yet many of us use insulin and being able to track blood sugars continuously can significantly improve control.

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@David_dns

Sorry for the long post, however, I thought this might answer your question.

Nemaura Medical Present Positive Interim Clinical Trial Results of its sugarBEAT® System
5th October 2015, Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing the sugarBEAT® CGM System as a minimally invasive, wireless continuous glucose monitoring system, announced today that it has conducted a further interim analysis of clinical data from its ongoing 540 patient day clinical program of Type I and Type II diabetic Patients, and have determined a reduction in MARD from 18% to 11.8%. MARD is the Mean Absolute Relative Difference between finger-stick measurements and CGM sensor glucose values; a lower MARD indicates higher accuracy.

Nemaura Medical previously reported an interim evaluation that indicated the primary endpoint of accuracy and secondary endpoint of safety had been met. The current evaluation was taken from a further 76 patient day study, consisting of 19 patients wearing the device on four separate days, for 12 hours per day. The CGM data was compared with blood finger prick analysis using the Hemocu BGM device, up to 3 times per hour. Despite the enhanced results the skin safety profile was maintained without any complaints of adverse skin irritation.

The sugarBEAT® device displays real time glucose readings on the device and on a mobile phone app via blue tooth. Nemaura have patents that allow the device to self-calibrate using an internal standard concept, eliminating the need for routine daily finger prick calibrations. The company plans to submit for CE approval of the device by the end of 2015 and launch in Europe and other select territories by mid 2016 via strategic partnerships and licensees. Nemaura Medical is also currently preparing to file a pre-submission application to the FDA to consolidate their US clinical roadmap and product approval process.

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Impressive MARD considering it’s non-invasive, a definite plus. Hopefully it will be less expensive than what’s available now, which might mean it’s accessible to more people, particularly those with T2.

This certainly sounds encouraging. How does that MARD compare to currently available systems, e.g., Dexcom?

The G4 Platinum without the 505 update was 13%. The update improved it to 9%, which is what the G5 is.

If memory serves, the 7 Plus had a MARD of 16%. I honestly couldn’t tell much difference in the accuracy with each upgrade.

For this new contender to have comparable accuracy without an injected sensor is quite an achievement. If they keep the price in an affordable range, I would definitely be interested.

My daughter and I love her Dexcom G5 so very much. She enjoys a scary level of accuracy, and I have come to appreciate that she and her Dexcom are as one. And the wonderful and knowledgable Dexcom folks (with one exception in the many, many times I have contacted them) have been so polite, patient, and helpful to the point of going above and beyond. This has, for me, led to a fierce brand loyalty, the likes of which I haven’t experienced since being won over by Best Foods (“Hellman’s” east of the Rockies) mayo. Unless there is a significant price savings (and a comparable MARD), switching from Dexcom to anything else would feel like cheating on a spouse…

I see a few problems:

  • Still only theory, to be launched 2016, read available in Europe during 2018, if at all
  • The patch needs to be changed every day (lasts for 24h)
  • The patch needs to be connected to an electronic device - how, cable, BT?
  • It draws fluid from the skin, but without penetration - how? The only fluid that can be drawn is the sweat.
  • It requires one blood test per day for calibration.

To me, this is not better than Freestyle Libre, which is available today, in any way.

How it works

“Passing a mild, non-perceptible electric current across the skin, our patented technology draws a small amount of selected molecules, such as glucose, into a patch placed on the skin. These molecules are drawn out of the interstitial fluid which naturally sits just below the top layer of skin.”

"Easily extended to other molecules (or analytes) and medicinal drugs present in the interstitial fluid of the skin, our technology has broad ranging potential clinical and non-clinical applications, including:

– Diabetes (glucose monitoring)
– Athletic performance monitoring (lactate monitoring)
– Intensive care (glucose monitoring and oxygen depletion)

Our blood glucose monitoring product, SugarBEAT® is anticipated to launch in Europe at the end of 2016, with at least one additional application expected to be commercialised in 2017."

From their website

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Changing the patch everyday could be an advantage for anyone who has issues with current sensor adhesives.

By not limiting the application only to diabetes, I would think their market potential will be much broader. That can help keep costs down for all users.

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