The OTC CGM Revolution: Transforming How We Monitor Health"
Well, it finally happened. The United States has its first over-the-counter (OTC) Continuous Glucose Monitor (CGM) coming to market. This news is going to cause a lot of waves in the healthcare space, but it didn't come from nowhere and has a bit of history to it.
Current CGM Market
Several things need to be considered when we talk about the CGM market. The big players are Abbott and Dexcom, with Medtronic and several other companies making significant moves. However, Abbott Freestyle Libre and Dexcom CGM devices have been the predominant players for the past 5 years and have heavily shifted the diabetes market in terms of how we think of treatment.
We now have devices that reduce patients' cognitive load to monitor and manage their blood glucose. It is pretty much a defunct therapy in the Type 1 space, and it is heavily adopted by Type 2 patients on insulin.
The data shows a lower incidence of hospitalizations and better A1c ranges. A rise in time-in-range (TIR) measurements is also being adopted, which the ADA guidelines are integrating. However, data also supports the use of CGM for patients not on insulin, and many people without diabetes have been using CGMs for health and wellness.
I want to emphasize that last point. Because it really matters for these device manufacturers. They make money selling devices. We know the market limits if we only address the Type 1 or patients on the insulin market. It's sizable, but... when we see data that patients not on insulin and just oral medications can benefit and that even patients using CGM to help manage their health can benefit, you start wondering how much of a larger market you can attain.
And thats where Abbott was playing in the past few years. In the EU, Abbott announced biosensors in 2020 called 'Libre Sense' that were also OTC, and meant for athletes and the health market. Come 2022, Abbott announced their 'Lingo' product at CES, which again, was meant for the health market, but still not available in the US.
In the meantime, Dexcom announced on January 24 at the JP Morgan Healthcare event that it planned to release a new CGM for patients not on insulin, Stelo, based on its G7 model sensor. The difference here likely was that Stelo wouldn't have to worry about hypoglycemic events as drastically compared to the other CGMs that insulin was tied with in use.
OTC CGM Drops
However, in March 2024, Stelo was announced as an OTC CGM targeted for patients not on insulin. Based on the lingering fact that these device companies see an oppurtuniy to catch a larger market beyond insulin patients, trying to get their products to a wider population just makes sense. That OTC announcement is new and will shake up the market with Dexcom being the potential first mover that may shift the CGM conversation.
How does this change things?
Back when Abbott had announced Lingo, I had put together some initial thoughts, which I think I can expand upon now that we do have an OTC product:
OTC Gold Rush: No CGM device company is going to let Dexcom get that far ahead. I expect Abbott to follow, and then a further push from other companies who are invested in this space. I wouldn't be surprised if we see some companies abandon an Rx product and just move for the OTC route if they feel that the CGM Rx market is already crowded.
Pre-Diabetes Intervention: PCPs and other providers will probably start recommending these OTC CGMs to their patients at risk of diabetes. The data may help reinforce healthy behaviors, which feeds into the following...
Wellness/Coaching Explosion: I fully expect to see a rise in health coaches leveraging OTC CGMs to help their patients with their dieting and exercise plans. We already have so many companies that have set up a virtual DTC business to Rx CGM online and mail directly to their customers; this OTC CGM business, I would argue, will cut into that model (and Abbott and Dexcome have likely seen this market as a key driver for the OTC push to increase their market size). So this may lead to Weight Watchers, Peloton, and other tech health companies tapping into these sensors (and possible partnerships for reduced costs). In addition, I feel that other local coaches and clinics will likely also get involved.
More CGM Integration: More data means more integration. If we see apps getting on board, I think we'll see more developements around how to improve some of the data visualization across perhaps Apple Health or related platforms.
New Biosensors: I think we'll see more biosensors if the OTC market gets enough push. Maybe ketones and related products will become available. Based on Abbott's media, I feel like that may be their target market, while Dexcom has not expressed beyond diabetes. However, other companies may want to compete with Abbott.
Patient Education Needed: Patients are going to need education on these tools. I think the pharmacy and pharmacists can play a good role in this space, but again, payment concerns are gonna come up for our time. Nonetheless, with more use, I think we'll see a lot of on-screen media targetting people soon.
Cost Issues: For now, I think costs will be moderately high, though incentives will be available to drop costs. No idea if insurance will cover it, but I think they will; just the difference if you are on insulin or not to delineate which product you go on. For patients without diabetes, I think other companies will want to compete with Dexcom or Abbott based on cost.
New Population Health Data: I am really excited about the use of new data sources regarding population health related to prediabetes and diabetes management. I think we'll get much more nuanced insights than we have had in the past, and pharmaceutical companies and other organizations will readily watch this development.
New Business Partnerships: With Eli Lilly Direct, and now Dexcom Stelo online, I would be interested in seeing if we see pharma and device manufacturers just start bundling kits together to make a better patient engagement experience overall.
Final Thoughts
Several years ago, we saw a deluge of people giving family members genomic test kits. I wonder if we'll see the shift towards giving a biosensor for Christmas. Why not see how the Christmas sweets impact your blood glucose!
Joking aside (maybe), I do think Dexcom made the right moves and that other companies will swiftly follow. The movement of CGM towards just biosensors for health, I think, will be the next social topic that we'll see market shapers push for, and that will have a huge impact across the health sphere.