[Diabetes-Talk] FDA Clears First Over-the-Counter Continuous Glucose Monitor: What to Know About Biosensors - CNET

[David Andrews]

>
>CNET - Wednesday, March 6, 2024 at 6:01 PM
>
>
>FDA Clears First Over-the-Counter Continuous 
>Glucose Monitor: What to Know About Biosensors - CNET
>
>
>
>The US Food and Drug Administration on Tuesday 
><https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor>cleared 
>the first over-the-counter continuous glucose 
>monitoring system (CGM) in the US -- the Dexcom 
>Stelo Glucose Biosensor System -- expanding 
>glucose monitoring to people with Type 2 
>diabetes who don't need insulin and opening it 
>up to adults who want to track their blood sugar for nonmedical purposes.
>
>The FDA noted in its clearance that Stelo isn't 
>designed to be used by people with low blood 
>sugar and that you shouldn't make any health 
>care decisions based on what CGM and partnering 
>app tell you without consulting a doctor. This 
>makes it different than 
><https://www.cnet.com/health/medical/best-continuous-glucose-monitors/>traditional 
>CGMs for people with Type 1 diabetes.
>
>"Today's clearance expands access to these 
>devices by allowing individuals to purchase a 
>CGM without the involvement of a health care 
>provider," Dr. Jeff Shuren, director of the 
>FDA's Center for Devices and Radiological 
>Health, said in a news release. "Giving more 
>individuals valuable information about their 
>health, regardless of their access to a doctor 
>or health insurance, is an important step 
>forward in advancing health equity for US patients."
>
>Dexcom had 
><https://investors.dexcom.com/news/news-details/2024/Dexcom-Reports-Preliminary-Unaudited-Revenue-for-the-Fourth-Quarter-and-Fiscal-Year-2023-and-Initial-2024-Outlook/default.aspx#link=%7B%22linkText%22:%22submitted%22,%22target%22:%22%22,%22href%22:%22https://investors.dexcom.com/news/news-details/2024/Dexcom-Reports-Preliminary-Unaudited-Revenue-for-the-Fourth-Quarter-and-Fiscal-Year-2023-and-Initial-2024-Outlook/default.aspx%22,%22role%22:%22standard%22,%22absolute%22:%22%22%7D>previously 
>announced it would launch Stelo as a new type of 
>CGM designed specifically for people with Type 2 
>diabetes who don't use insulin and it would be 
>available this summer. Abbott, another company 
>besides Dexcom that dominates the diabetes care 
>space, also has a prescription-free 
><https://www.hellolingo.com/>biosensor that 
>tracks glucose levels coming to the US, expected sometime this year.
>
>The FDA's clearance of Stelo may reflect a 
>growing interest in glucose tracking -- a health 
>metric traditional wearables like smartwatches 
>and smart rings 
><https://www.cnet.com/health/medical/the-fda-wants-to-remind-you-that-your-smartwatch-cant-measure-blood-sugar-yet/>can't 
>touch yet. It also reflects companies' interest 
>in biosensing technology, which has 
>traditionally been reserved in CGMs for people 
>with Type 1 diabetes but is slowly pooling over 
>into general "wellness" territory.
>
><https://www.cnet.com/ces/>At CES this year, for 
>example, companies came forward with the latest 
>developments in biosensors, which have been in 
>the works for years but only recently started to 
>shape into something the average consumer could 
>benefit from, though at a notably high price.
>
>This could include the 
><https://www.cdc.gov/diabetes/basics/prediabetes.html>one 
>in three US adults in "prediabetes" territory, 
>where blood sugar levels are high but not yet 
>high enough to constitute a Type 2 diabetes 
>diagnosis. While there isn't much research 
><https://www.health.harvard.edu/blog/is-blood-sugar-monitoring-without-diabetes-worthwhile-202106112473>currently 
>supporting the use of biosensors or 
>glucose-tracking in people without diabetes 
>(some 
><https://www.healthline.com/health/high-blood-sugar-without-diabetes#hyperglycemia-without-diabetes>glucose 
>fluctuations are normal), proponents of 
>biosensors or wider glucose-tracking see them as 
>a tool that may avert a preventable health 
>condition, like Type 2 diabetes, by further 
>connecting people to how their lifestyle affects 
>the invisible parts of their health.
>
>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
>
>
>What are biosensors?
>
>
>
>Biosensors are a wearable you stick to a part of 
>your body, like your arm, to lift health data 
>using a tiny sensor. 
><https://www.cnet.com/health/medical/best-continuous-glucose-monitors/>Continuous 
>glucose monitors, or CGMs, for people with Type 
>1 diabetes have been the main product.
>
>Stelo was designed to be another option for 
>people with Type 2 diabetes who want immediate 
>insights into how their body is processing blood 
>sugar, based on what they're doing and what they 
>eat. It may also provide more useful, catered 
>information than the generalized advice people 
>get on managing blood sugar or diabetes at the 
>doctor's office, Dexcom's chief operating 
>officer, Jake Leach, explained Jan. 10 during a 
><https://live.ces.tech/detail/6344776020112/the-future-of-biosensing-technology-diabetes-and-beyond#link=%7B%22role%22:%22standard%22,%22href%22:%22https://live.ces.tech/detail/6344776020112/the-future-of-biosensing-technology-diabetes-and-beyond%22,%22target%22:%22%22,%22absolute%22:%22%22,%22linkText%22:%22digital%20health%20panel%20at%20CES%22%7D>CES 
>panel.
>
>"They're told 'eat less, exercise more,'" Leach 
>said. "That's not very helpful."
>
>Dexcom isn't releasing Stelo's price right now; 
>it'll become available when it rolls out online 
>this summer, a Dexcom spokesperson said, adding 
>that Stelo will be available at a "competitive 
>price." While consumer biosensors and CGMs have 
>been prohibitively expensive 
>(<https://nixbiosensors.com/products/hydration-biosensor>Nix, 
>a biosensor that measures hydration, costs $129 
>for four patches, for example), Dexcom says its 
>prescription-free CGM will provide an option for 
>people 
><https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx>without 
>health insurance.
>
>Two years ago at CES, Abbott announced a 
><https://www.cnet.com/health/medical/wearable-sensors-that-track-glucose-ketones-and-alcohol-levels-are-the-future/>consumer 
>line of biosensors called Lingo. Recently, the 
>glucose-monitoring version launched in the UK, 
>and a rollout in the US is expected to follow 
>sometime this year, following FDA clearance. 
>Down the line, Lingo will be able to measure 
>things like ketones in the blood. The 
>biowearable pairs with a "coaching" app that's 
>meant to help users connect the dots between their health data.
>
>A two-week Lingo pack costs 89 euros ($97), 
>which includes one sensor that lasts 14 days. An 
>eight-week pack costs 300 euros ($327).
>
>The idea behind sensors like this, when not used 
>for diabetes management, is to provide people 
>with information about how what they eat affects 
>their blood sugar and potentially how glucose 
>levels reflect daily trends, like 
><https://www.cnet.com/health/medical/sleeping-more-may-reduce-your-risk-of-diabetes-new-study-suggests/>how 
>much sleep someone is getting.
>
>Continuous monitoring of glucose levels in 
>people without diabetes has been an 
><https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10658694/>emerging 
>health trend, so more research is needed on the usefulness of this data.
>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. Recently, the 
>glucose-monitoring version launched in the UK.
>Abbott
>
>Better Type 1 diabetes care at CES 2024
>
>
>At CES this year, Abbott, Dexcom and Tandem 
>showcased their latest improvements in automated 
>technology that will, hopefully, improve the 
>everyday lives of those with Type 1 diabetes.
>
>Over the summer, Tandem 
><https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-mobi-worlds-smallest-durable-insulin-delivery-system>announced 
>its Mobi insulin pump, the world's smallest 
>FDA-cleared automated insulin delivery system. 
>At CES 2024, the company brought it in for a 
>showcase ahead of its anticipated launch early 
>this year. This hybrid-closed-loop system works 
>with CGMs to continuously administer insulin as 
>needed, directly through an app. Mobi will 
>initially be compatible with the Dexcom G6 
>sensor, with Dexcom G7 and Abbott's Freestyle 
>Libre 2 Plus sensor compatibility anticipated to follow.
>
>Abbott and Tandem also just announced a US 
>integration of Abbott's newest continuous 
>glucose monitor, the 
><https://www.freestyle.abbott/us-en/products/freestyle-libre-2-plus-sensor.html#link=%7B%22role%22:%22standard%22,%22href%22:%22https://www.freestyle.abbott/us-en/products/freestyle-libre-2-plus-sensor.html%22,%22target%22:%22_blank%22,%22absolute%22:%22%22,%22linkText%22:%22FreestyleLibre%202%20Plus%20Sensor%22%7D>FreestyleLibre 
>2 Plus Sensor, with Tandem's T:slim X2 insulin pump.
>A screenshot of the Lingo app and sensor
>
>Tandem app and new Mobi device
>
>
>New technology in diabetes care, like Tandem's 
>Mobi, gives people who need insulin more options in their health care.
>Tandem
>
>Will biosensing be useful health tech or a 
>wellness 'extra' for those who can afford it?
>
>
>Even though CGMs and automated insulin delivery 
>systems have been available for a while, their 
>reach has been limited to people with Type 1 
>diabetes who are either willing to use 
>technology to manage their health and/or those 
>whose insurance can pay for it. While people 
>with Type 1 and Type 2 diabetes who use CGMs 
>have fewer instances of hypoglycemia (low blood 
>sugar) and lower 
><https://www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html#:~:text=The%20A1C%20test%E2%80%94also%20known,care%20team%20manage%20your%20diabetes.#link=%7B%22linkText%22:%22AC1%22,%22target%22:%22%22,%22href%22:%22https://www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html#:~:text=The%20A1C%20test%E2%80%94also%20known,care%20team%20manage%20your%20diabetes.%22,%22role%22:%22standard%22,%22absolute%22:%22%22%7D>AC1 
>(average blood sugar level) than those who 
>don't, 
><https://diabetes.org/advocacy/cgm-continuous-glucose-monitors#:~:text=People%20with%20type%201%20and,hypoglycemia%20and%20a%20lower%20A1C.#link=%7B%22linkText%22:%22cost%20and%20insurance%20coverage%22,%22target%22:%22%22,%22href%22:%22https://diabetes.org/advocacy/cgm-continuous-glucose-monitors#:~:text=People%20with%20type%201%20and,hypoglycemia%20and%20a%20lower%20A1C.%22,%22role%22:%22standard%22,%22absolute%22:%22%22%7D>cost 
>and insurance coverage remain barriers to 
>actually getting one, according to the American Diabetes Association.
>
>Even if biosensors do one day near the mass 
>appeal that wearables like the Fitbit and Apple 
>Watch have been able to achieve, ease of 
>purchase will be one factor to consider, no 
>matter how promising the wellness waters look 
>through a biosensor. But generally speaking, 
>more insight into metabolic health, and how one 
>factor affects another, stands the chance to 
>improve people's wellness and reduce risk of chronic disease before it begins.
>
><https://www.cnet.com/health/medical/in-2024-biosensors-are-becoming-more-accessible-what-it-means-for-you/#ftag=CAD590a51e>https://www.cnet.com/health/medical/in-2024-biosensors-are-becoming-more-accessible-what-it-means-for-you/#ftag=CAD590a51e