FDA Clears First Over-the-Counter Continuous Glucose Monitor: What to Know About Biosensors

FDA Clears First Over-the-Counter Continuous Glucose Monitor: What to Know About Biosensors

The US Food and Drug Administration on Tuesday 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 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 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 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 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.

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 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 currently supporting the use of biosensors or glucose-tracking in people without diabetes (some 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: 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. 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 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 (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 without health insurance. 

Two years ago at CES, Abbott announced a 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 how much sleep someone is getting. 

Continuous monitoring of glucose levels in people without diabetes has been an emerging health trend, so more research is needed on the usefulness of this data.

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 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 FreestyleLibre 2 Plus Sensor, with Tandem’s T:slim X2 insulin pump.

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 AC1 (average blood sugar level) than those who don’t, 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.

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