Non-invasive no-lag continuous glucose monitor starting clinical trials

I noticed that this device just received breakthrough designation from FDA:

Company site: https://www.hagartech.com/

A few articles on it:

Key points:

  • Measures glucose in blood and not interstitial fluid using wrist-based sensor.
  • “over 95% accurate when compared to an off-the-shelf handheld finger-prick device.” (Abbott FreeStyle specifically)
  • Claims to be more accurate than Dexcom or Libre.
  • Doesn’t need to be calibrated.
  • No disposable parts.
  • There’s no final device yet, but they aim to integrate it into a smartwatch.
  • Just raised over $17B in series B funding.
  • Starting a 250-subject clinical trial by the end of the year and another one soon after.

Looks pretty promising to me- this one is now on my radar. But I do think that they should reconsider their acronym of NIG for “Non-Invasive Glucose Monitoring”.

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@bwschulz Hey, that’s great news! I had read about Gwave several weeks ago and mentioned them in another topic area a few weeks back. Great to know about the FDA action and it appears to be progressing! Appreciate your keeping track of FDA actions! It would be great to just have to look at my watch, though I charge mine at night and wouldn’t be able to check BGs or would need a second “device”. I imagine it will drain power significantly as well…come on better batteries!

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We have Liam’s BGs on the big screen while we sleep. SugarMate or Nightscout via browser on the TV has made looking at BGs easy for my wife and I… No rolling over to get anything… Just lift eye cover, peek, back to sleep. Worth considering is those are options available to you for nighttime monitoring.

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Yeah, that FDA designation is promising but not as useful as it recently was. Up until early November any devices with Breakthrough designation would automatically get up to four years of Medicare coverage once the product received approval or cleared the agency’s market authorization. But that rule was recently repealed and “at least two” public meetings will be held during 2022 about this. So not sure what the benefits are or will be, but at least the tech is moving forward and seems promising.

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I am open to being a skeptical Beta tester. I will be fair, but honest in my report.

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Won’t be the first promising diabetes tech to not work in the real world, either through measurement difficulties in sub-optimal conditions/patients, or in the inability to actually miniaturize the tech. With that being said, I hope they are hugely successful on both fronts. Another thought, the huge Type 2 market is ensuring people keep their eye on diabetes tech and that it gets funded, so for that I say thanks to all the Type 2’s out there that ensure that investments will continue to be made that benefit all diabetics.

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You’re welcome, from one of the T2 mob

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@ClaudnDaye That’s an inventive use of the TV! Any problems with burn in of the image? I know newer sets are less prone, depending on type (LED, OLED, etc.). Not sure the wife would go for that with our current set; despite the “black” claims, it puts off quite bit of “light” into the room.

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No. It does go to sleep after a while though and screen saver starts so i have to click a button on the remote to get it back on the screen. It’s probably a setting but i haven’t investigated honestly.

No bleed that i see at all.

I have to have total darkness so I wear a cover over my eyes but both the SugarMate and NS are dark-ish

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Since this watch uses micro needle technology, I did a search and found this paper:

I was trying to find a study on the long term effects of using a micro needle device in the same place. So far no luck.

Reading the link you posted, I think the study cohort is way too small.

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it is small but I think it is great to see new tech being developed

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Definitely worth keeping track of and further investigation! I can see that the micro needle could become an irritant, I even have to give my very smooth Apple Watch a breather now and again to keep from having an irritation develop. I hadn’t worn a watch for several years after retiring from work, also no rings since USAF pilot training in the 80’s (…that movie of a guy getting hung up on exiting an aircraft and loosing a finger/tendon had the desired effect!). It will be interesting see what tech wins the race to market and longer term.

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Hmmm…no mention of latency or accuracy. It uses microneedles instead of adhesive patches, but this sure sounds a lot like a Glucowatch 2.0, which was to laggy and uncomfortable for anyone to want to use.

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I’m using a blujay mk2 cbgm watch that uses the spare slot on my dexcom g6 transmitter and also links with my phone.its a stand alone device which can be linked to all the dexcom features by the xdrip app.charging isn’t an issue since I think I only charge it every 5 or 6 days.im 45yrs old and diagnosed T1 last year so I’ve been lucky enough to have found this tec that allows me to check bg as easy as checking the time.

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@TomH That is one benefit to the iphone 13, (I highly dislike the facial recognition lol) but the iphone 13 has made a huge improvement in it’s battery life. I used to drain my iphone battery constantly. . Now I rarely run out of battery power. Plus the lightening charge is a lot faster. So they are improving the batteries.

@ClaudnDaye I’m not sure if the iphone is involved in what you do, but if it is, under settings, display and brightness you can switch it to never to shut off at night, then it wouldn’t go to sleep. .

@TomH Besides leaving the iphone on the never shut off and in it’s charger. Every night before bed I set my iphone to dark mode and at it’s dimmest light settings. I also had put Siri into a short cut so the Dexcom screen is a small block in the black ap. It stays on the screen until you touch the shortcut and sits upright in the charger for me to just glance at it. The only time it seems to bother me is if I wake up and I have trouble going back to sleep then I can get touchy and I flip it down on the nightstand. It still puts out some light but most of the time it doesn’t bother me and I go back to sleep. It is pretty dim, but I do wish it was dimmer as we are just both used to a pitch black room. The Dexcom ap itself even at the dimmest settings is way too bright as it’s a white screen.

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Tangentially, how is it that the FDA can move forward with GWave but can’t get their act together for the Omnipod 5?

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I don’t know what the issue with the Omnipod 5 is, but this isn’t a clearance or approval for the GWave. They only granted it breakthrough device status that may expedite insurance coverage once approved. And they are nowhere near approval yet- data still needs to be collected.

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Believe it or not some of the most under appreciated people in most companies are the FDA strategy team. Each submission needs to be carefully considered and an approach used that will result in the shortest FDA approval process, with all that being said, much of it is the workload at the moment you get assigned a reviewer and the luck of whether that reviewer has the background to understand your submission. If they don’t, i.e. one of my friends got an FDA reviewer on their first solo approval, and it took forever because since they didn’t have the experience to know which questions to ask, they asked every possible question and cost his company +$250,000 and 8 months longer approval process than expected.

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