Abbott Receives U.S. FDA Clearance for Two New Over-the-Counter Continuous Glucose Monitoring Systems

Rhea-AI Summary

Abbott (NYSE: ABT) announced FDA clearance for two over-the-counter continuous glucose monitoring systems, Lingo™ and Libre Rio™. These systems are based on Abbott's FreeStyle Libre® technology. Lingo is aimed at general consumers wanting to improve their health by tracking glucose levels, offering personalized insights and coaching. Libre Rio is designed for adults with Type 2 diabetes who manage their condition through lifestyle changes, providing a measurement range of 40-400 mg/dL. This move aims to make glucose monitoring more accessible, potentially improving health outcomes and quality of life for a broader population.

Positive

• FDA clearance for two new CGM systems enhances Abbott's product portfolio.
• Lingo targets the general wellness market, widening Abbott's consumer base.
• Libre Rio caters to adults with Type 2 diabetes, expanding Abbott's diabetes management solutions.
• FreeStyle Libre technology is already trusted by 6 million users globally.
• Lingo and Libre Rio offer over-the-counter accessibility, removing the need for prescriptions.
• Clinical data shows FreeStyle Libre systems help improve glucose control and lower HbA1c.
• Abbott's continued investment in innovation includes developing a dual glucose and ketone sensor.

Negative

• Potential competition in the CGM market could impact market share.
• Over-the-counter products may face challenges in user compliance and proper usage.
• Regulatory risks and potential delays in product rollout could affect sales.
• The effectiveness of personalized coaching and overall user satisfaction remains to be seen.

Insights

Financial Analyst

Abbott's recent FDA clearance for Lingo™ and Libre Rio™ reflects a strategic move into a rapidly growing market for glucose monitoring. Both products leverage Abbott's well-established FreeStyle Libre® technology, already trusted by about 6 million users worldwide, providing a robust foundation for market adoption.

From a financial perspective, these new products could significantly boost Abbott's revenue streams. Lingo™ targets a broader market – general consumers interested in overall wellness, thus moving beyond medical necessity into the lucrative wellness industry. The potential market size here is extensive, given that only 12% of Americans are metabolically healthy. This product's success could hinge on effective marketing and consumer education to drive adoption.

Meanwhile, Libre Rio™ aims at Type 2 diabetics who don't use insulin, estimated at around 38.4 million people in the U.S. alone. The over-the-counter availability could lower barriers to entry, driving higher adoption rates and potentially increasing Abbott's market share in the diabetes management sector. Additionally, it aligns with the general trend towards over-the-counter medical products, reducing dependence on prescription-based sales and possibly improving profit margins.

In the short term, these product launches could lead to increased R&D and marketing expenses, which may temper immediate profit margins. However, the long-term outlook appears positive, with the potential for substantial revenue growth, improved market penetration and diversification of Abbott's product portfolio.

Rating: 1

Medical Research Analyst

The introduction of Lingo™ and Libre Rio™ represents significant advancements in continuous glucose monitoring technology. Both products extend the application of Abbott's established FreeStyle Libre® platform, which is already proven to improve glucose control and reduce diabetes-related complications.

For the general consumer, Lingo™ offers personalized coaching based on glucose data. This could be a game-changer in metabolic health management. Personalized health insights and actionable data have been shown to significantly impact behavior change, potentially leading to better health outcomes. This aligns with broader health trends where consumers seek more proactive and personalized approaches to managing their health.

On the other hand, Libre Rio™ caters to a specific yet large demographic – Type 2 diabetics who manage their condition through lifestyle changes. The expanded measurement range (40-400 mg/dL) is particularly noteworthy as it provides comprehensive glucose level insights, enabling better management of both hypoglycemia and hyperglycemia through non-pharmacological means. This could result in significant improvements in patient outcomes, reduce healthcare costs associated with poorly managed diabetes and support a preventive health strategy.

However, widespread adoption will depend on consumer acceptance and the perceived value of continuous glucose monitoring outside traditional medical use. Ensuring accessibility and affordability will be important in driving uptake among both target groups.

Rating: 1

• Abbott's consumer biowearable, Lingo™, is designed for general consumers who are looking to improve their overall health and wellness
• Libre Rio™ is designed for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications
• Both products are based on FreeStyle Libre^® sensing technology, the world's most widely used¹ continuous glucose monitoring (CGM) systems, pioneered by Abbott and used by about 6 million people globally²

ABBOTT PARK, Ill., June 10, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology¹, now used by about 6 million people globally². The newly cleared systems have been intentionally designed to meet different needs – Lingo for consumers who want to better understand and improve their health and wellness, and Libre Rio for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.

"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 technology¹," said Lisa Earnhardt, executive vice president and group president of Abbott's medical devices business. "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."

Lingo
Abbott's consumer biowearable, Lingo, is designed for consumers 18 years and older who are looking to improve their overall health and wellness. Lingo will track glucose and provide personalized insights and customized coaching to help people create healthy habits, retrain their metabolism and improve their overall well-being.  

According to a University of North Carolina study, only 12 percent of Americans are metabolically healthy³ based on five key indicators of metabolic health, including glucose levels, indicating that most of the U.S. population has room to improve their metabolism. In addition, in a recent online consumer survey conducted by The Harris Poll on behalf of Abbott, 82 percent of Americans say they would change their habits if a biowearable provided actionable, personalized coaching to help them manage their health.⁴

The Lingo system combines a biosensor that is worn on the upper arm for 14 days⁵ and continuously streams glucose data to a coaching application on a smart phone – translating the body's language and giving insights on the person's reaction to food, exercise and life's daily stressors.   

"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," said Fred St. Goar, M.D., cardiologist and medical director of El Camino Health Heart and Vascular Institute. "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." 

Visit www.hellolingo.com and sign up to be notified as soon as Lingo is available in the U.S. Lingo is also available in the UK. 

Libre Rio
Libre Rio will be Abbott's first over-the-counter CGM system for people with diabetes in the U.S. It is designed for people ages 18 and older with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications. Libre Rio is the first over-the-counter CGM system with a measurement range of 40-400 mg/dL, allowing for measurement of extremely low or high glucose events.

Diabetes is among the top public health challenges in the U.S., with approximately 38.4 million people living with the condition⁶. FreeStyle Libre systems have been available over-the-counter in more than 50 countries over the last decade; however, in the U.S., they have only been available through prescription.

Libre Rio will join Abbott's overall Libre portfolio of CGM systems, now used by about 6 million people across more than 60 countries². The Libre portfolio in the U.S. consists of the FreeStyle Libre 2 and FreeStyle Libre 3 systems for people with all types of diabetes – Type 1, Type 2 and gestational. FreeStyle Libre systems require a prescription and have wide reimbursement by most major insurers in the U.S.² Libre Rio may make it easier for Americans with diabetes to try a CGM and begin to see progress toward their health goals, empowering them with information to discuss with their healthcare provider at their next visit.

Clinical and real-world data from the millions of people that use FreeStyle Libre systems show that the technology helps people improve their glucose control, lower their HbA1c, decrease diabetes-related hospital admissions, and improve their quality of life^7,8. Libre systems consist of a biosensor placed on the back of the arm for up to 15 days, and a reader or a compatible smartphone app⁹, which displays glucose measurements.

Abbott continues to invest in its world-leading innovation for people with diabetes, including expanding manufacturing capacity and developing a first-of-its-kind sensor that is designed to measure both glucose and ketone in the same sensor.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube. 

About Lingo:
The Lingo Glucose System is intended for users 18 years and older not on insulin. It is not intended for diagnosis of diseases, including diabetes.

The Lingo program does not guarantee that everyone will achieve the same results as individual responses may vary. Consult your healthcare professional before making changes to your diet or exercise regimen or if you have an eating disorder or a history of eating disorders.

About Libre Rio:
Libre Rio is an over-the-counter integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons ages 18 and older. Failure to use Libre Rio as instructed in labeling may result in missing a severe low or high glucose event. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions.

Important Safety Information about FreeStyle Libre systems:
For Important Safety Information, please visit https://www.freestyle.abbott/us-en/safety-information.html.

1. Data on file. Abbott Diabetes Care. Data based on the number of patients assigned to each manufacturer.
2. Data on file. Abbott Diabetes Care.
3. Prevalence of Optimal Metabolic Health in American Adults: National Health and Nutrition Examination Survey 2009-2016.
4. This survey was conducted online within the United States by The Harris Poll on behalf of Abbott from March 7 - 11, 2024 among 2,060 adults ages 18 and older.  The sampling precision of Harris online polls is measured by using a Bayesian credible interval.  For this study, the sample data is accurate to within +/- 2.5 percentage points using a 95% confidence level.
5. A study was conducted to assess the biosensor life where 77.1% of biosensors lasted the full 14 days. In other words, when using the product per the package labeling, approximately 22.9% of biosensors may not last for the full 14 days. 14.7% of biosensors may last less than 11 days.
6. American Diabetes Association, Statistics About Diabetes, accessed March 20, 2024.
7. The American Journal of Managed Care, Flash CGM Associated With Event Reduction in Nonintensive Diabetes Therapy, 2021.
8. American Diabetes Association, Continuous Glucose Monitors, accessed March 20, 2024.
9. The FreeStyle Libre systems are only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app.

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SOURCE Abbott

FAQ

What are Abbott's new continuous glucose monitoring systems?

Abbott has launched Lingo and Libre Rio, two over-the-counter continuous glucose monitoring systems.

When did Abbott receive FDA clearance for Lingo and Libre Rio?

Abbott received FDA clearance on June 10, 2024.

Who are the target users for Abbott's Lingo system?

Lingo is designed for general consumers looking to improve their overall health and wellness.

Who can benefit from Abbott's Libre Rio system?

Libre Rio is designed for adults with Type 2 diabetes who manage their condition through lifestyle modifications.

What is the measurement range of Libre Rio?

Libre Rio has a measurement range of 40-400 mg/dL.

How many people globally use Abbott's FreeStyle Libre technology?

About 6 million people globally use Abbott's FreeStyle Libre technology.

What are the benefits of Abbott's continuous glucose monitoring systems?

Abbott's CGM systems help improve glucose control, lower HbA1c, and enhance overall quality of life.

Where can U.S. consumers sign up for more information on Lingo?

U.S. consumers can visit www.hellolingo.com to sign up for more information.