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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“Artificial Intelligence” may be one of the biggest buzzwords of 2023, and for good reason: fitness and health companies are among the leading players harnessing the simulation of human superpowers. Among those major players are food industry titans, who are clamoring in test kitchens, using algorithms to create recipes designed to make palatable yet healthy food. 

As consumers continue to adopt healthy habits and as weight loss medications such as Ozempic and Wegovy are clobbering shares of snack and beer companies, it’s likely prudent for the food industry to lean into creating healthier (but still tasty) products.

January AI, a metabolic health platform, looks at the current landscape as a crisis, heightened by rising healthcare costs and an alarming statistic from the CDC that 37.5 million Americans (roughly one in ten) have diabetes, with one in five unaware that they have the condition. It’s a grim picture, but one that January AI has set out to change by promoting well-informed eating with generative AI.

Launched in 2017 by Noosheen Hashemi and Stanford University’s Dr. Michael Snyder, January AI says its approach can help end lifestyle-related diseases.

January AI’s Digital Twin 

The metabolic health platform uses wearables to help users decide what to eat by combining continuous glucose monitoring, generative AI and a database of 32 million food items, but it takes it a step further. Users can now access a digital twin, to see how certain food selections will impact their digital twin’s blood sugar.

It’s the equivalent of offering consumers a science-backed crystal ball in which they can see the potential impact of certain foods on the body, therefore encouraging them to make healthier meal choices.

Nestlé Embraces AI

The platform is helpful to consumers, but it’s also proving valuable to major food companies, such as Nestlé. The multinational food and drink leader is using January AI’s digital twin technology as it considers AI for product innovation, such as personalized nutrition for those with special considerations, like diabetes.

According to January AI, the food industry has the potential to enhance the taste and texture of food, as well as its glycemic impact on the body, by using its digital twin capabilities.

“Our digital twin technology gives food companies an additional level of intelligence beyond what they already employ in their product development process,” explained Hashemi, CEO of January AI. “We’re able to help them see how people with diabetes or pre-diabetes would do on their various foods and decide how to reformulate their foods to be healthier for the population. This allows for virtual product development and optimization before any costly lab work is undertaken.”

AI-Powered Cheese

Along with food industry leaders, biotech companies are also exploring the power of AI to make nutrition more personalized and even positively impact the environment.

Climax Foods, a biotech startup, made news this summer for using “precision formulation” AI to discover a plant-based protein ingredient that mimics the melting magic and texture of casein, a dairy protein in cheese. A win for those with allergies, dairy sensitivities or a vegan lifestyle, Climax Foods credits its proprietary AI and data science process for discovering a new approach in creating AI-powered cheese.

Instead of attempting to genetically engineer plants to make proteins, Climax Foods says it uses data science and machine learning to model different formulations while also uncovering what makes certain foods “craveable” to human taste buds. 

While it may sound reminiscent of a high school chemistry class, Oliver Zahn, CEO and founder of Climax, explains that the company isn’t changing any ingredients genetically, but is using what already exists.

“Plants can impart all of the same texture, taste, and performance of animal-based ingredients – our AI-enabled Deep Plant Intelligence platform takes away the guesswork,” Zahn said. “For our casein replacement, our AI platform and precision formulation process helped us uncover a mechanism in specific plant proteins that imparts indistinguishable melt and stretch and mouthfeel from casein while also dramatically improving nutrition.”

Although it’s focused on dairy products at the moment, Climax Foods has its sights set on food products far past cheese. Zahn confirmed that the biotech company’s AI process can one day be applied to replace other animal-based foods. 

“This is one of the most important scientific breakthroughs in food in the last six thousand years—since humans invented animal agriculture – but we are only getting started,” Zahn said.

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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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January AI, a health tech company, has introduced a generative AI-enabled app that evaluates and predicts glucose response to 32 million foods, even when members are not wearing a continuous glucose monitor (CGM). 

While monitoring CGM was once reserved mainly for those with diabetes, ongoing research shows managing blood sugar is elemental to good health and correlates to weight, cholesterol, and inflammation. 

January’s app allows everyday consumers to see the data and impact of food choices ahead of time.

The system, $288 for the first month and then $28 after, allows consumers uncover the complexities of their health data and arm them with information to help them on their journey to health.

The goal of January AI is to support a healthier lifestyle by going beyond glucose prediction and into behavior-shifting, which the tech health company says includes intermittent fasting, increasing fiber consumption, aligning calorie intake with activity level, getting post-meal movement and reducing glucose-spiking foods. 

“Think of it as a weather report. If it only told you it’s already raining, you wouldn’t find it very useful,” said Noosheen Hashemi, who co-founded the health tech company in 2016 with Stanford University’s Director of Genomics, Dr. Michael Snyder, Ph.D. 

January members will enter foods they are considering eating into the app, and the predictive AI model will tell them what the food will do to their blood sugar levels, offering a sneak peek at what may happen if indulging in a snack.

The health tech company says members will be able to see the predicted glucose curve projected up to two hours into the future. 

“It helps them make better decisions about what they’re about to put into their body, kind of like having an AI nutritionist in your pocket to let you know whether you should order a smoothie or an arugula salad, and what happens if you take a 25-minute walk afterwards,” added Hashemi.

The AI-powered app comes at a time when obesity rates are climbing and also at a pivotal moment when consumers are becoming increasingly interested in health and nutrition, which many experts suggest is a result of the pandemic. 

“The metabolic crisis is far more prevalent as an endemic than COVID was as a pandemic,” Dr. Snyder said in a recent interview. “Getting glucose under control is a big, big deal. Nearly 100 million people are walking around with prediabetes, and 90% don’t even know it. If we don’t measure people’s health, does it mean they’re healthy?”

January also can also integrate data from other wellness partners, such as Oura Ring, Apple Health and Fitbit, further analyzing health data to provide valuable insights and recommendations for users.

The app tracks post-meal activity to nudge members to move immediately after eating, which is shown to help lower blood sugar. On the nutrition side, it will provide macros, track fiber intake and give daily reminders so members stay on track to reach their health goals. 

The health benefits can even promote improved sleep habits, which resonated with Tom Hale, Oura CEO. Oura recently acquired a digital ID startup to carve out its own tech advancements with its wearable ring. 

“We are excited to work with companies like January AI to provide sleep insights to their members,” Hale said. “January’s last-meal-sleep-gap helps members gain awareness about how their mealtime choices can affect the quality of their sleep.”

Consumers complete a brief telehealth evaluation to receive a CGM prescription, and once approved, January will deliver the CGM. After the January AI app is downloaded and has enough data to obtain a health baseline, which takes a week, its AI algorithms kick in and provide actionable insights. After two weeks, the platform no longer requires a CGM to display glucose curves, insights and predictions.

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