Provide Counseling About OTC Blood Glucose Tools

The number of individuals diagnosed or at risk for prediabetes and diabetes continues to expand, with the ongoing obesity epidemic as one of the principle contributing factors. According to the CDC, an estimated 38.4 million individuals (representing 11.6% of the population) in the United States have diabetes, including both undiagnosed and diagnosed cases.1 Additionally, an estimated 96 million adults in the United States are classified as prediabetic, representing more than 1 in every 3 adults. The CDC also notes that more than 80% of individuals with prediabetes and an estimated 20% of individuals with diabetes are unaware of the diagnosis, highlighting the need to expand awareness about diabetes, clinical signs, and risk factors.¹

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Pharmacists play a crucial role in expanding patient awareness about the significance of early recognition and implementing patient-centered preventive and clinical interventions to reduce, prevent, and treat diabetes effectively. This is paramount in improving clinical outcomes and health-related quality of life (HRQOL), as well as diminishing the health and economic burdens associated with diabetes.

The American Diabetes Association (ADA) indicates that routine self-monitoring of blood glucose is one of the most effective tools for monitoring diabetes and determining the effectiveness of selected therapy. Data from several studies have validated the critical nature of sustaining glycemic control to effectively manage diabetes and diminish or avert the numerous health-related complications associated with poorly controlled or undiagnosed diabetes.^2-5

Self-monitoring of blood glucose provides critical insights into daily glucose patterns, serving to ensure that fasting and postprandial targets are met. This approach can also help to identify and prevent hyperglycemia and hypoglycemia episodes and provide valuable information on how glucose levels respond to food, medications, physical activity, sleep, stress, illness, and therapy changes. Pharmacists are well positioned to assist patients in selecting tools for self-monitoring blood glucose, including blood glucose meters (BGMs) and the recently FDA-approved OTC continuous glucose monitors (CGMs).

Blood Glucose Meters

Numerous self-testing BGMs are on the market. Technologies continue to advance and features now include improved portability with more compact devices, less invasive and less painful testing procedures, smaller sample size requirements, alternate site testing capabilities, and quicker testing results that can be incorporated into daily routines. Many meters also have an app to track results, maintain a log, and share data with a primary health care provider.

OTC Continuous Glucose Monitors

The ADA indicates that the availability of CGMs provides health care providers and patients with another tool to meticulously monitor glucose levels, providing valuable clinical data in real-time via a biosensor worn on the back of the upper arm that transmits glucose readings to a receiver, a smartphone, or smartwatch.⁶ The ADA also notes that data from CGMs can assist prescribers in making therapy and lifestyle adjustments when warranted and reduce patient burdens of frequent BGM fingersticks throughout the day.⁶

Until recently, CGMs were available via prescription only for patients with diabetes who were taking insulin. Because of advancements in technology and expanding awareness about the benefits of CGMs, the FDA has recently approved a few OTC CGMs, increasing accessibility to include a larger group of patients. Although study data are limited, experts believe these tools could be particularly helpful for individuals with prediabetes, and the use of CGMs can result in clinically meaningful improvements in time in range, hemoglobin A1C levels, and HRQOL.^7,8

In March 2024, the FDA approved the first OTC CGM, the Stelo Glucose Biosensor System, created by the manufacturers of the Dexcom G7.⁸ The Stelo CGM is indicated for use in individuals 18 years and older who are not using insulin, including individuals diagnosed with diabetes using oral antidiabetic medications or those without diabetes who want to learn how factors such as diet and exercise may affect blood glucose levels. The novel CGM became available to patients on August 26, 2024.⁹ Importantly, the manufacturer and FDA state that this CGM is not for individuals with problematic hypoglycemia. The small sensor, worn on the back of the upper arm, lasts up to 15 days and provides continuous glucose readings via a smartphone or smartwatch app.^8,9

On June 10, 2024, Abbott announced the FDA clearance of the Lingo and Libre Rio OTC CGMs. The Lingo is designed for patients 18 years and older who are trying to improve their overall health and wellness, whereas the Libre Rio is designed for individuals 18 years and older with type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications. Both sensors are based on Abbott’s FreeStyle Libre technology and have the same shape and size as the Freestyle Libre 2 and Libre 3 sensors.10 The Libre Rio is anticipated to be available by the end of 2024.¹⁰

Conclusion

Pharmacists can expand awareness about diabetes and its related complications, encourage patients to seek further medical evaluation when warranted, and identify patients who may benefit from selfmonitoring using a BGM or the novel FDA-approved OTC CGMs. Pharmacists can also educate patients about the proper use of these devices, provide information about pros and cons, and remind patients to discuss modifiable and nonmodifiable risk factors for diabetes and obtain recommendations regarding using a BGM or a CGM with their primary health care provider.

BGMs and OTC CGMs are effective tools that can assist patients in taking control of their health and overall well-being. Educating patients on diabetes prevention and management provides them with knowledge that will enable them to make informed decisions about their health to improve clinical outcomes and HRQOL. Taking steps to prevent or improve prediabetes and diabetes outcomes is always a step in the right direction.

REFERENCES

1. National diabetes statistics report. CDC. May 15, 2024. Accessed October 11, 2024. https://www.cdc.gov/diabetes/php/dataresearch index.html

2. Liu QZ, Pettitt DJ, Hanson RL, et al. Glycated haemoglobin, plasma glucose and diabetic retinopathy: cross-sectional and prospective analyses. Diabetologia. 1993;36(5):428-432.doi:10.1007/BF00402279

3. Espeland M. Look AHEAD: action for health in diabetes (V9, dataset). NIDDK Central Repository; 2023. Accessed October 11, 2024. https://repository.niddk.nih.gov/studies/look-ahead/

4. American Diabetes Association Professional Practice Committee. 6. Glycemic targets: standards of medical care in diabetes-2022. Diabetes Care. 2022;45(suppl 1):S83-S96. doi:10.2337/dc22-S006

5. Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycemia in type 2 diabetes, 2022: a consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753-2786. doi:10.2337/dci22-0034

6. ElSayed NA, Aleppo G, Aroda VR, et al. Diabetes technology: standards of care in diabetes-2023. Diabetes Care. 2023;46(suppl1):S111-S127. doi:10.2337/dc23-S007

7. Aungst C. Are continuous glucose monitors available OTC? plus, answers to 6 other FAQs. GoodRx. March 7, 2024. Accessed October 11, 2024. https://www.goodrx.com/classes/medicalsupplies-and-devices/otc-continuous-glucose-monitor-faqs

8. Stelo by Dexcom first glucose biosensor cleared by FDA as over-the-counter. News release. Dexcom. March 5, 2024. Accessed October 11, 2024. https://investors.dexcom.com/news/newsdetails/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx

9. Stelo by Dexcom, the first over-the-counter glucose biosensor in the U.S., is now available. News release. Dexcom. August 26, 2024. Accessed October 11, 2024. https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-the-First-Over-the-Counter-Glucose-Biosensor-in-the-U.S.-Is-Now-Available/default.aspx

10. Abbott receives U.S. FDA clearance for two new over-thecounter continuous glucose monitoring systems. News release. Abbott. June 10, 2024. Accessed October 11, 2024. https://www.prnewswire.com/news-releases/abbott-receives-us-fda-clearancefor-two-new-over-the-counter-continuous-glucose-monitoringsystems-302167780.html