[Diabetes-Talk] Blood Sugar Tracking Heats Up: FDA Clears 2 New Monitors, Another to Roll Out This Summer

[David Andrews]

>
>CNET - Friday, June 28, 2024 at 11:55 AM
>
>
>Blood Sugar Tracking Heats Up: FDA Clears 2 New 
>Monitors, Another to Roll Out This Summer
>
>
>
>As far as our body's energy needs are concerned, 
>blood sugar is as sweet as it sounds. While 
>people with diabetes need to monitor its levels 
>to ensure their body has the appropriate amount 
>to stay safe, blood sugar (or blood glucose) is 
>everybody's primary form of energy. How well the 
>body uses blood sugar is also a measure of 
><https://zoe.com/learn/what-is-metabolic-health>metabolic 
>health -- a term the medical community is still 
>working out that describes how the body uses 
>energy, and how at-risk someone may be for 
><https://www.hopkinsmedicine.org/health/conditions-and-diseases/metabolic-syndrome>health 
>problems like heart disease.
>
>But accurately tracking blood sugar, or even 
>putting a firm finger on what it means to be 
>"metabolically healthy," is tricky. Consumer 
>wearables like smartwatches and smart rings 
>can't measure blood glucose, despite the 
>existence of 
><https://www.cnet.com/health/medical/the-fda-wants-to-remind-you-that-your-smartwatch-cant-measure-blood-sugar-yet/>some 
>counterfeit devices on the market that haven't been FDA cleared.
>
>The world of blood sugar has been the domain of 
>diabetes tech companies, which already have 
>sensors and technology -- 
><https://www.cnet.com/health/medical/best-glucose-meter/>continuous 
>glucose monitors -- many people with diabetes 
>use every day. And the companies leading 
>diabetes tech have also been laying down the 
>framework to make metabolic health more mainstream.
>
>In addition to people with diabetes, continuous 
>glucose monitors have been 
><https://www.forbes.com/sites/rebeccasuhrawardi/2022/02/25/glucose-monitoring-is-the-weight-loss-biohack-you-never-knew-you-needed/>used 
>for "biohacking" glucose levels by people who 
>want to know how their body responds to food or 
>what impacts their glucose levels. Companies 
>such as 
><https://www.nutrisense.io/what-is-a-cgm/cost>Nutrisense 
>use CGMs that require a prescription, but take 
>care of it through their websites.
>
>This month, the US Food and Drug Administration 
><https://abbott.mediaroom.com/2024-06-10-Abbott-Receives-U-S-FDA-Clearance-for-Two-New-Over-the-Counter-Continuous-Glucose-Monitoring-Systems>cleared 
>two new CGMs from Abbott for use without 
>prescription: One for people with Type 2 
>diabetes who don't require insulin (the Libre 
>Rio), and the other a consumer-friendly patch 
>for the general public 
>(<https://www.cnet.com/health/medical/wearable-sensors-that-track-glucose-ketones-and-alcohol-levels-are-the-future/>the 
>Lingo, which made its debut at CES 2022). Both 
>of Abbott's over-the-counter CGMS are based on 
>its 
><https://www.cnet.com/health/medical/best-continuous-glucose-monitors/>popular 
>FreeStyle Libre sensor technology.
>
>Rolling out in late August is Dexom's Stelo, a 
>prescription-free CGM designed for people with 
>diabetes who don't need insulin. It was cleared 
>by the FDA earlier this year, making it the 
><https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor>first 
>over-the-counter CGM.
>
>Here's what we know about the new 
>over-the-counter CGMs, as well as insight from a 
>company working on a new, non-invasive way to measure blood sugar.
>
>Read more: 
><https://www.cnet.com/health/medical/the-fda-wants-to-remind-you-that-your-smartwatch-cant-measure-blood-sugar-yet/>The 
>FDA Wants to Remind You That Your Smartwatch Can't Measure Blood Sugar Yet
>
>
>Over-the-counter CGMs are rolling out this summer. Who actually needs one?
>
>
>
>Dexcom said the Stelo will be available in late 
>August. It's designed for people with Type 2 
>diabetes who don't need to take insulin but it's 
>been 
><https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor>cleared 
>by the FDA for any adult who wants to "better 
>understand how diet and exercise may impact blood sugar levels."
>
>Like other wearable sensors used by people with 
>diabetes, Stelo attaches to your upper arm. A 
>tiny sensor that goes slightly below your skin 
>then reads blood glucose information and sends 
>it to a paired app, allowing you to track your 
>blood sugar information throughout the day and make note of any trends.
>
>Abbott's consumer biosensor, the Lingo, will 
>also be available this summer, the company said. 
>It didn't provide a timeline for when the Libre 
>Rio, which is meant for people with Type 2 diabetes, will be available.
>
>However, the question of "who actually needs 
>these?" remains. As Dr.Robert H. Shmerling wrote 
>in an 
><https://www.health.harvard.edu/blog/is-blood-sugar-monitoring-without-diabetes-worthwhile-202106112473>article 
>for Harvard Health Publishing, CGMs can cost 
>several thousand dollars a year, and companies 
>marketing their use for the general public stand 
>to make a big profit in an area of health that, 
>as of now, 
><https://www.goodrx.com/classes/medical-supplies-and-devices/otc-cgm-for-non-diabetics>does 
>not have the research supporting it outside 
>diabetes management. In its press release, 
>Abbott pointed to research finding that just 12% 
>of American adults are 
><https://www.liebertpub.com/doi/full/10.1089/met.2018.0105>considered 
>"metabolically healthy," but glucose 
>measurements are just one of a few factors used to qualify metabolic health.
>
>On the other hand, 
><https://www.cdc.gov/diabetes/prevention-type-2/prediabetes-prevent-type-2.html?CDC_AAref_Val=https://www.cdc.gov/diabetes/basics/prediabetes.html>1 
>in 3 Americans have prediabetes -- a step before 
>Type 2 diabetes which can be reversible. 
>Providing actionable information on 
>higher-than-average blood sugar trends could 
>provide many people with the information needed 
>to make choices for their health -- if they can 
>afford it, that is. Neither Dexcom nor Abbott 
>have provided exact prices for their consumer 
>CGMs at this time, but costs for CGMs for people 
>with diabetes who do not have health insurance 
><https://diabetes.org/advocacy/cgm-continuous-glucose-monitors#:~:text=One%20obstacle%20with%20CGMs%20is,for%20people%20who%20need%20them.>remains 
>a barrier to health care access.
>
>Because consumer CGMs don't require a 
>prescription and many cases likely wouldn't be 
>considered medically necessary, someone who may 
>have a higher risk of developing Type 2 diabetes 
>would still likely pay top dollar for an 
>over-the-counter CGM. The high cost of 
>biosensors is one reason there's interest in 
>non-invasive, even more consumer-friendly measures of tracking blood sugar.
>
>Read more: 
><https://www.cnet.com/tech/services-and-software/an-ai-built-digital-twin-could-improve-your-health-this-startup-says/>An 
>AI-Built 'Digital Twin' Could Improve Your Health, This Startup Says
>A screenshot of the Lingo app and sensor
>
>A screenshot of the Lingo app and sensor
>
>
>At CES 2022, Abbott announced a new line of 
>consumer biowearables called Lingo for people 
>who don't have diabetes and don't need a 
>prescription. They launched first in the UK and 
>are expected to hit the US market this summer.
>Abbott
>
>Non-invasive blood sugar monitoring makes an 
>appearance at the American Diabetes Association conference
>
>
>
>There's no way to accurately measure blood sugar 
>levels without getting at least a little bit 
>under someone's skin. Even CGMs require a tiny 
>sensor on the wearable patch, even though it's 
>arguably less invasive than a finger prick.
>
>One company, <https://www.knowlabs.co/>Know 
>Labs, is working to change that. The company was 
>at the 
><https://professional.diabetes.org/scientific-sessions>American 
>Diabetes Association Scientific Sessions in 
>Orlando over the weekend and 
><https://a44151fe-7b16-4476-be18-58e9029d95fc.usrfiles.com/ugd/a44151_d1a4d414bfef4aa0bf1835ee573bfe6e.pdf>presented 
>promising results on the ability of its wearable 
>device, the KnowU, to get stable readings of 
>blood sugar without penetrating the skin. The 
>company is still a ways out from having a device 
>ready for the market and it's still collecting 
>data to send to the FDA -- the prototype is 
>still bulkier than a CGM, potentially making it 
>a harder sell even if it's less invasive. But 
>the company is expanding on the use of photonics 
>and sensors already integrated into smartwatches 
>and used to measure factors like blood oxygen.
>
>Because LEDs can't accurately track glucose 
>information, Know Labs had to go "further out on 
>the electromagnetic spectrum," the company's CEO 
>Ron Erickson told CNET. He said that, while a 
>medical-grade device is likely the first step 
>for the company, he's not opposed to opening up 
>the patented technology to consumer wearable devices.
>
>Calling Know Labs' technology "form-factor 
>agnostic," Erickson wants glucose tracking to 
>feed health trends -- which is the whole point 
>of consumer wearables that give you health trends.
>
>"My longer vision, beyond glucose, is predictive health," he said.
>
><https://www.cnet.com/health/medical/blood-sugar-tracking-heats-up-fda-clears-2-new-monitors-another-to-roll-out-this-summer/#ftag=CAD590a51e>https://www.cnet.com/health/medical/blood-sugar-tracking-heats-up-fda-clears-2-new-monitors-another-to-roll-out-this-summer/#ftag=CAD590a51e