CGMs and the Metabolic Tracking Race
Janel L. Davis, PhD | Freelance Science Writer
In late summer 2024, the US welcomes the arrival of the first over-the-counter (OTC) continuous glucose monitors (CGMs) with the launch of Dexcom’s (DXCM) Stelo and Abbott’s (ABT) Lingo. These new offerings join the thriving biowearables market, providing consumers with insights into their body’s functioning and potentially enabling behavioral changes for improved health. Alongside the Lingo, the FDA has also approved Abbott’s Libre Rio, which will be marketed to a different population than the Lingo. While no other CGM manufacturers have entered the OTC CGM arena, it will be interesting to watch the next steps of major players like Medtronic (MDT- Guardian, Simplera), Roche (RHHBY- Accu-Chek Smartguide), and Eversense (SENS- Eversense E3).
Given the highly anticipated changes to the metabolic health landscape, it is crucial to understand the current access to CGMs and the potential impact their widespread use could have on new markets.
What are CGMs?
Continuous glucose monitors (CGMs) were initially developed for insulin-dependent diabetics who cannot produce insulin, the hormone responsible for regulating blood sugar. For Type-1 diabetics, CGMs have been integrated with insulin pumps to create a closed-loop system that helps regulate blood sugar levels.
Unlike traditional blood glucose monitors which rely on finger sticks, CGMs are attached subcutaneously to the back of the arm or stomach via a tiny needle. After extracting the needle, the remaining filament continuously measures glucose levels in the interstitial fluid, providing snapshots every five minutes. Typically, CGMs last 14-15 days, and the data is synced with a smartphone app with a 20-minute delay between measurement and display.
As CGM technology has evolved into compact wireless devices, their appeal has extended beyond the initial patient group. The first obvious new population is non-insulin-dependent Type 2 diabetics, who make up 90% of the 38 million people in the US with diabetes. Studies have shown that CGMs can be effective for optimizing diets and maintaining healthy glucose levels in both Type 1 and Type 2 diabetics.
Dexcom’s Stelo, a simplified version of their G7, will be marketed directly to non-insulin-dependent Type 2 diabetics. However, given its broad label, the device will also be accessible to non-diabetics. Similarly, Abbott’s Rio will target this population. Meanwhile, the Lingo device will be marketed as a metabolic health device for non-diabetics.
Why would CGMs be useful for non-diabetics?
Although there is limited data to show the benefits of glucose monitoring in otherwise healthy individuals, several startups have already developed metabolic health and nutrition coaching businesses centered around CGM data. Companies like Nutrisense, Levels, Signos, Veri, and Zoe all offer AI-driven apps that integrate with Abbott’s FreeStyle Libre or Dexcom’s G7. Because these companies utilize FDA-regulated devices that require prescriptions, consumers must undergo a medical consultation or enroll in a trial to access the CGM devices. It remains unclear how the availability of OTC offerings will impact the approaches of these CGM service providers.
Thus far the most significant application for non-diabetics includes potentially driving behavioral changes in the 84.1 million adults with prediabetes. For otherwise healthy individuals, CGMs are being promoted as tools to enhance fitness regimens, assist with maintaining a healthy diet and lifestyle, or for short-term use to establish baselines and track the effects of various lifestyle changes.
Currently, the price of OTC CGMs in the US has not been announced, however, Abbott’s Lingo in the UK has been marketed for $116 (£89) per device. The price for CGM services is even higher with the most affordable service including a CGM starting at $179. Since glucose is only a single biomarker, many companies are pairing CGMs with nutritional coaching programs. It remains to be seen whether these paired coaching options will be sufficient to prevent consumers from misinterpreting CGM data. Additionally, in the age of data collection, the management and use of data from metabolic trackers will be a crucial area to watch. Lastly, widespread interest in CGM devices could potentially lead to shortages for individuals who genuinely need access.
Beyond glucose monitoring, other metabolic monitoring systems, including ketone and lactate levels, are being developed. Despite the high price point and limited evidence demonstrating the utility of glucose measurements in healthy individuals, widespread access to CGMs may signal the beginning of a new era for biowearbles.
About the Author: Janel Davis is a science communicator specializing in pharma/biotech and medtech content. As a note, her thesis was on spectroscopic super-resolution microscopy so questions related to stochastically emitting fluorophores are always welcome.
