FDA Approves 2 New OTC Continuous Glucose Monitors


The Lingo and Libre Rio from Abbott are based on the company’s FreeStyle Libre sensing technology.

The FDA has provided clearance to 2 over-the-counter (OTC) continuous glucose monitor (CGM) systems, health care technology company Abbott announced in a release.1 The new OTC devices are based on the company’s FreeStyle Libre sensing technology, which is the most widely used CGM system in the world.

FDA Approves 2 New OTC Continuous Glucose Monitors / stivog - stock.adobe.com

FDA Approves 2 New OTC Continuous Glucose Monitors / stivog - stock.adobe.com

The Lingo and Libre Rio were both designed to meet different consumer needs. The Lingo aims to help adults gain a better understanding of their health and improve wellness, while the Libre Rio is for adults with type 2 diabetes (T2D) who do not use insulin and typically manage their disease through lifestyle modifications. The approval for Abbott’s CGMs comes shortly after Dexcom received the first CGM OTC approval for its Stelo Glucose Biosensor System.

READ MORE: CGM, Wearable Device Data to Improve Mortality, Establish Lifestyle Changes

"There is no one-size-fits all approach for glucose monitoring, which is why we've designed different products for different people—all based on the same world-leading biowearable technology," Lisa Earnhardt, executive vice president and group president of Abbott's medical devices business, said in a release.1 "People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider. People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes."

The Libre Rio is the first OTC CGM that has a measurement range of 40-400 mg/dL, which allows the device to detect extremely low or high glucose events. The device is based on Abbott’s FreeStyle Libre system, which has proven to help people with diabetes improve their glucose control, lower their HbA1c, decrease diabetes-related hospital admissions, and improve their quality of life.2 The CGM provides measurements via a biosensor that is placed on the back of the arm for up to 15 days, which is compatible with a reader or smartphone app.

The Lingo CGM, designed for general adult use, can track glucose levels, provide personalized insights, and give customized coaching to “help people retrain their metabolism and improve their overall well-being.” The system uses a biosensor that is worn on the upper arm for 14 days. Paired with a smartphone app, the device continuously streams glucose data to give users insights on food reactions, exercise and daily stressors.

According to data published in the Journal PLOS ONE, around 4 to 9% of people with a normal weight are metabolically unhealthy. However, that number jumps to between 54% and 63% in people with obesity.3 Although CGMs were created for people with diabetes, the devices can also help people without the disease screen for early detection of diabetes, inform their nutritional behavior, manage stress levels, and optimize athletic performance.4

"Continuous glucose monitors are a tool I recommend to my patients to raise their overall awareness of factors that affect their glucose and are an invaluable holistic wellness solution," Fred St. Goar, MD, cardiologist and medical director of El Camino Health Heart and Vascular Institute, said in a release.1 "Research has shown that overall lower glucose exposure in the general population is associated with reduced long-term risk to developing cardiovascular disease, diabetes, Alzheimer's and certain cancers. Making continuous glucose monitors widely available will undoubtedly have a dramatic effect on the overall health and well-being of the broader population."

READ MORE: Continuous Glucose Monitoring Resource Center

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1. Abbott Receives U.S. FDA Clearance for Two New Over-the-Counter Continuous Glucose Monitoring Systems. News Release. Abbott. June 10, 2024. Accessed June 11, 2024. https://abbott.mediaroom.com/2024-06-10-Abbott-Receives-U-S-FDA-Clearance-for-Two-New-Over-the-Counter-Continuous-Glucose-Monitoring-Systems
2. Miller E, Kerr MSD, Roberts GJ, et al. Flash CGM associated with event reduction in nonintensive diabetes therapy. Am J Manag Care. 2021 Nov 1;27(11):e372-e377. doi: 10.37765/ajmc.2021.88780. PMID: 34784145.
3. Fernández-Verdejo R, Moya-Osorio JL, Fuentes-López E, et al. Metabolic health and its association with lifestyle habits according to nutritional status in Chile: A cross-sectional study from the National Health Survey 2016-2017. PLoS One. 2020 Jul 22;15(7):e0236451. doi: 10.1371/journal.pone.0236451. PMID: 32697789; PMCID: PMC7375524.
4. Holzer R, Bloch W, Brinkmann C. Continuous Glucose Monitoring in Healthy Adults-Possible Applications in Health Care, Wellness, and Sports. Sensors (Basel). 2022 Mar 5;22(5):2030. doi: 10.3390/s22052030. PMID: 35271177; PMCID: PMC8915088.
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