FDA clears the first OTC continuous glucose monitoring system

The FDA has cleared Dexcom's Stelo, a continuous glucose monitoring system (iCGM) that can be purchased without a prescription.

It is cleared for adults 18 and older who do not use insulin, and healthy individuals who want to understand their own glucose patterns can use it too.

iCGM: integrated continuous glucose monitor

OTC: Over-the-counter

Although Stelo's price has not yet been announced, it is expected to threaten Abbott's US$80-per-month FreeStyle Libre.

Historically, Dexcom has mostly priced above Abbott's products; experts estimate a price of about US$90 per month, with further discounts available through US health savings accounts.

Analysts say the FDA's clearance of an OTC iCGM has undoubtedly set a high bar,

as achieving high accuracy demands heavy costs and long R&D timelines — beyond incumbents Dexcom and Abbott, other competitors will struggle to break through.

The obesity dividend

Stelo's market is non-insulin-dependent diabetes patients — more than 25 million people in total, even larger than the insulin-therapy market. With obesity worsening and type 2 diabetes numbers rising, plus potential applications for prediabetes and metabolic health, demand for continuous glucose monitoring technology keeps growing.

Abbott poised to strike

By some estimates, the market potential for Dexcom and Abbott spans more than 100 million potential users, and Abbott is also weighing the launch of an over-the-counter product, Lingo, which would further extend its market reach.

References

FDA Approval For DexCom's Stelo Opens Continuous Glucose Monitoring To Masses, Analyst Expects Competitive Pricing Against Abbott's | Markets Insider (businessinsider.com)

FDA Clears First Over-the-Counter Continuous Glucose Monitor | FDA

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