The U.S. Food and Drug Administration has cleared the Dexcom Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor (CGM), as awareness of metabolic health continues to gain steam. 

The system will become available to purchase online without a prescription this summer. 

The wearable Stelo Glucose Biosensor System is designed for those 18 years and older who don’t use insulin and either treat diabetes with oral medications or don’t have a diabetes diagnosis but are interested in seeing firsthand how diet and exercise impact their blood sugar levels.

Using a small sensor worn on the back of the upper arm, Stelo continuously measures, records, analyzes and displays glucose values every 15 minutes when connected to an app. Users can wear each sensor for up to 15 days before replacement.

Stelo isn’t designed for those with “problematic hypoglycemia” since it won’t provide the necessary alerts. 

Although Dexcom notes that Stelo users shouldn’t take medical action based on the device’s findings without consulting with a healthcare professional, the health tech company says the glucose biosensor system can help users understand how modifications such as diet and exercise can impact glucose excursion. 

Considering that approximately one in three American adults have prediabetes — a staggering 80% of whom don’t know they have it —  Stelo can serve as an invaluable tool, underscored by its ease of accessibility. It’s a stance that appears to be shared by the FDA.

“CGMs can be a powerful tool to help monitor blood glucose,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider.

“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 U.S. patients,” Shuren continued.

While a price hasn’t been mentioned yet, one William Blair analyst estimates Stelo may cost around $90 a month and that consumers could use their healthcare savings accounts to offset the expense.

Consumers Embrace Wearables for Health

By all accounts, consumers are entering a new era of health and wellness. The pandemic may have inspired health and wellness, but it also led to skyrocketing sales of pulse oximeters, perhaps a testament to how much consumers have come to rely on monitoring devices beyond fitness and activity trackers.

Instead of simple trackers, companies such as Whoop bill their technology as ‘human performance,’ leaning into AI and providing biometric data points across sleep, recovery, stress and strain.

Smart ring maker Oura is also invested in the glucose realm, having partnered with CGM platforms Veri, Supersapiens and January AI to offer insights into sleep and glucose biomarkers.

One wearable tech startup, Signos, raised $20 million last year as it looks to disrupt the medicated weight loss and metabolic space by using Dexcom CGMs to provide real-time diet and workout recommendations based on the readings with its app.  

The CGM Market Heats Up

Although Stelo may be the first CGM cleared for over-the-counter purchase, the CGM space is expected to become increasingly competitive. Abbott’s first consumer biowearable, Lingo, is currently being rolled out across the U.K. with ambitions of receiving a green light for the U.S. market. Similar to Stelo, it tracks glucose levels and provides personalized insights in response.

“Our mood, weight, energy levels and ability to focus are all connected to our individual glucose levels, which rise and fall in response to the food we eat, hours of sleep, regular exercise, and even life’s daily stresses,” said Lily Soutter, a nutritionist in Abbott’s Lingo division. “Improving your metabolic health by tracking your glucose levels over a meaningful period of time can motivate you to implement changes to better manage those spikes and dips, ultimately benefiting your health and well-being.”

Meanwhile, companies like Roche are forging a new frontier in diabetes management and the CGM space using predictive AI for its Accu-Chek SmartGuide device. Using a CGM sensor, Roche’s system displays current glucose levels, predictions for the following two hours and provides a risk prediction for nocturnal hypoglycemia.

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Signos, a metabolic health platform that combines a continuous glucose monitor (CGM) with an AI-powered app to provide real-time data and make health-centered recommendations, has secured $20 million in a Series B round.

The new funding, led by Cheyenne Ventures and Google Ventures, with support from Dexcom Ventures and Samsung Next, will be used to expand the team at Signos and go towards additional metabolic health research.  

While continuous glucose monitors were once primarily reserved for diabetics, advances in technology and rising interest in health and wellness have led to an increase in the use of metabolic monitoring devices by everyone from non-diabetics to wellness enthusiasts.

Wearing a device for high-tech health monitoring isn’t a novel concept, particularly given how consumers have embraced fitness and health wearables. CGMs have also come a long way, providing customers with a discreet means to monitor their metabolic health with better accuracy and real-time valuable data.

Despite increased concern and focus regarding health, Americans are nevertheless facing a metabolic crisis, with 96 million classified as prediabetic and, as Signos points out, 1 billion people worldwide are projected to develop diabetes by 2050.

Looking to change those starting stats, Signos says its CGM provides users with a solution to reverse prediabetes and assist with long-term weight loss. After deciding on one of three monthly plans, members log meals and workouts in the Signos app, allowing the AI platform to learn how a user’s metabolism responds to different foods and exercise. 

A Long-Term Solution

The platform then offers recommendations based on a user’s unique metabolic profile. The insights are rich — users discover what foods are best for them, when to eat and when to exercise to bring their glucose levels back within range. 

Essentially, the goal is to navigate glucose spikes and dips, which may cause people to eat sooner than necessary and ingest more calories than needed. 

Signos also integrates with smart watches, smart scales and Apple Health data to track metrics. 

“Sleep, stress, exercise and diet all influence how high and sustained one’s glucose spikes can be,” said Sharam Fouladgar-Mercer, founder and CEO of Signos. “We often don’t realize that people make around 227 food-related decisions a day. By providing glucose visibility, tracking and AI-driven proactive suggestions, Signos can help you navigate those choices for better health.” 

Fouladgar-Mercer, who founded Signos in 2018, views the mission of the startup as somewhat personal, having been open about his own experience with weight management struggles. And although many consumers have started taking GLP-1 drugs such as Ozempic and Wegovy for weight loss, he doesn’t see the injectables as the ultimate solution. As Fouladgar-Mercer told CNBC, the headline-making medicine may kick off weight loss, but consumers often struggle to keep off the weight after stopping the medication. 

Signos also expanded its weight management platform for those living with Type 2 diabetes earlier this year, offering a separate program that pairs CGM technology and its app to promote health and weight control.

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Oura has partnered with continuous glucose monitor (CGM) platforms Veri, Supersapiens and January AI, providing users with valuable insights into the relationship between sleep and glucose biomarkers.

The smart ring company’s partnership with Veri, a CGM-assisted metabolic health platform, is designed to shed light on how lifestyle behaviors impact sleep patterns and overall metabolic health. 

Veri’s new insights tool uses Oura’s sleep staging algorithm to track nightly glucose levels and examines how factors such as exercise, food choices and meal times influence both glucose levels and sleep quality. By comparing REM and light sleep stages to glucose levels, users can also learn how sleep quality affects glucose regulation. For instance, indulging in alcohol or late-night snacks can raise glucose levels and disrupt sleep patterns, while poor sleep can have a negative impact on glucose levels, insulin sensitivity, weight and hormones.

“With Oura Ring, we’re bringing the key biomarkers of sleep stages, heart rate and glucose together for the first time to paint an even more holistic picture of metabolic health to unlock an unprecedented level of insight,” said Verneri Jaamuru, co-founder and chief product officer at Veri.

Oura also collaborated with two other CGM platforms, Supersapiens and January AI, which incorporate predictive AI into their offerings.

The new Oura Ring integrations come at a critical time. There is an alarming global prevalence of metabolic syndrome, a condition characterized by a combination of obesity, high triglycerides, low levels of HDL cholesterol, high blood pressure and insulin resistance.

Metabolic syndrome affects approximately one in four adults in Europe, and around one in three individuals in the U.S. and Australia. Good metabolic health is crucial in preventing serious conditions such as heart attacks, type 2 diabetes, and strokes. Unfortunately, sleep deprivation remains a prevalent issue, with one in three Americans and one in five U.K. citizens experiencing inadequate sleep.

The new Oura integrations represent a significant step forward in understanding the intricate relationship between sleep patterns, heart rate, glucose levels, and overall metabolic health. By leveraging these insights, individuals can make informed lifestyle choices to improve their well-being, while healthcare providers can develop more personalized strategies for combating the metabolic health crisis on a global scale.

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Apple has been exploring the idea of integrating a noninvasive glucose monitor into its Apple Watch for several years. Recent reports suggest that the company has made progress towards this goal.

According to Bloomberg, anonymous sources reported that Apple’s highly secretive Exploratory Design Group (known internally as XDG) has been working on the technology for years. In 2010, Steve Jobs directed Apple to buy noninvasive blood glucose monitoring startup RareLight to bring its technology to mobile devices. This effort has been squared away internally at Apple through project codenames and distinct employee badges.

Reports suggest that the company has managed to shrink the system to the size of an iPhone, but Apple wants to integrate the technology into the Apple Watch. Most continuous glucose monitors currently on the market rely on a tiny sensor inserted under the skin, which can be inconvenient and costly for some users. By integrating a continuous glucose monitor (CGM) into the Apple Watch, Apple could revolutionize diabetes care and make monitoring blood glucose levels more accessible and affordable. Speculation suggests that Apple is using optical spectroscopy and silicon photonics for the technology. A chip could output lasers into one’s skin and sensors would read the concentration of light to know how much glucose is present.

The potential benefits of an Apple Watch with a built-in glucose monitor are significant. For starters, it would eliminate the need for pinprick-style sensors and frequent transmitter replacements, which can be expensive and uncomfortable. CGMs cost anywhere from $100 to $1,000, while Apple Watches start at $249. Even if Apple were to make the CGM exclusive to its most expensive Ultra model, at $799, its monitor would not require regular replacements. Additionally, the monitor could alert prediabetic users to changes they could make to prevent adult-onset diabetes, a potentially life-changing feature.

Another advantage of integrating a glucose monitor into the Apple Watch is that it would work alongside other elements of a person’s Apple ecosystem, such as their iPhone or iPad. This could make it easier for users to track their glucose levels and share that information with their healthcare provider.

There are likely many regulatory hurdles that Apple would need to clear before bringing such a device to market. However, if Apple does manage to bring a glucose monitor to the Apple Watch in the next few years, it could be a game-changer for diabetes care. By making monitoring more convenient and affordable, Apple could help millions of people better manage their diabetes and potentially prevent the onset of Type 2 diabetes in others.

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