FDA Approves First OTC Continuous Glucose Monitor (2024)

FAQs

FDA Approves First OTC Continuous Glucose Monitor? ›

The US Food and Drug Administration (FDA) has cleared Dexcom's Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitoring (CGM) system. Unlike Dexcom's G6 and G7 CGM systems, the Stelo is intended for adults with or without diabetes who don't use insulin.

The Stelo Glucose Biosensor System is manufactured by Dexcom and will be available in the US this summer.

Dexcom's FDA-cleared Stelo CGM will be available in summer 2024. It'll be the first over-the-counter (OTC) option in the U.S., making CGMs more accessible. It's thought CGMs may help people shape lifestyle choices to improve their health.

In 1999, the U.S. Food and Drug Administration approved the first “professional” CGM, with which the patient was blinded to glucose data collected for 3 days, and then the information was downloaded in the health care provider's office for review.

The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a user's smartphone or other smart device, to continuously measure, record, analyze and display glucose values in people 18 years and older that are not on insulin and who do not have problematic hypoglycemia.

Nonprescription drug products may be marketed via two pathways: an OTC monograph or the drug approval process (i.e., new drug application [NDA] or abbreviated new drug application [ANDA]). OTC monographs are regulations the FDA has been establishing since 1972.

While you can buy the FreeStyle Libre 2 at pharmacies, you cannot purchase this system over the counter.

Dexcom has received clearance for the first over-the-counter (OTC) glucose sensor in the U.S. The Food and Drug Administration cleared the device, Stelo, for use by people 18 years and older who are not on insulin therapy after seeing evidence that it performs similarly to other continuous glucose monitors (CGMs).

Stelo will be available for purchase online without a prescription starting summer 2024.

Abbott's FreeStyle Libre 2 is one of the most affordable CGMs and may cost you up to 70% less than other devices. As mentioned above, according to the FreeStyle Libre 2 website, most people with commercial health insurance pay around $65 for the reader and $0 to $60 for the sensors monthly.

Can you get a CGM over-the-counter? ›

Are there any OTC continuous glucose monitors (CGMs)? Yes, there is an OTC CGM. In March 2024, the FDA cleared Dexcom's Stelo Glucose Biosensor System for OTC use.

The Eversense E3 is an implantable CGM that can be used for 180 days before replacement. The components of the CGM include: Implantable sensor. The sensor is inserted under the skin of the upper arm (and removed) every six months by a trained healthcare provider.

The motivation behind people without diabetes wearing CGMs is to (1) improve their glucose patterns and avoid diabetes, prediabetes, or other states of glycemic fluctuations that are outside of the typical normal range; (2) optimize their blood glucose concentrations to achieve peak mental or physical performance; and ...

Starting summer 2024, individuals across the US will be able to purchase a continuous glucose monitor (CGM) without needing a prescription.

On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom's Stelo Glucose Biosensor System (Stelo) is an integrated CGM (iCGM) designed for individuals 18 years and older who do not use insulin.

The Stelo glucose monitor. [Image courtesy of Dexcom] Dexcom (Nasdaq:DXCM) announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription. This marks the first FDA clearance for a continuous glucose monitoring (CGM) technology for over-the-counter use.

Today, June 24, 2021, Zealand Pharma announced that Zegalogue® (dasiglucagon) is commercially available in the U.S. in an auto-injector and prefilled syringe, after receiving FDA approval on March 22, 2021.

In 2006, Dexcom received U.S. Food and Drug Administration (FDA) approval and launched the Dexcom STS Continuous Glucose Monitoring System, which is a three-day sensor that provides up to 288 glucose measurements for every 24 hours.

Abbott's FreeStyle Libre® 3 Receives U.S. FDA Clearance - Features World's Smallest, Thinnest and Most Accurate 14-Day Glucose Sensor - May 31, 2022.