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FDA Approved Over-the-Counter Blood Sugar Monitoring Arrives- Important Considerations

Updated: May 2


On March 5th 2024, the US FDA approved the first over-the-counter continuous glucose monitor. (CGM) Before, it would cost a trip to the doctor and symptoms of diabetes before someone could get ahold of a device that read blood glucose continuously. Something that all doctors, trainers and nutritionists talk about is blood glucose, or sugar, in your bloodstream. Glucose is the primary source of energy for your body's cells, obtained from the food you eat. Maintaining stable blood sugar levels is essential for overall health, as fluctuations can lead to various complications, including diabetes. But maybe you’ve thought, whether it be prescribed by your doctor or purchased during your next grocery store visit, is a glucose monitor right for me?

Source: fda.gov News Release ‘FDA Clears First Over-the Counter Continuous Blood Glucose Monitor


Glucose, derived from carbohydrates, fuels your body, but imbalanced levels can lead to health issues like insulin resistance and diabetes. Insulin resistance occurs when cells don't respond well to insulin, raising blood sugar levels and heightening the risk of type 2 diabetes and heart disease. Type 1 diabetes results from the immune system attacking insulin-producing cells, requiring lifelong insulin therapy. Type 2 diabetes stems from insulin resistance and insufficient insulin production, often exacerbated by lifestyle factors like diet and obesity. High blood sugar levels in both types can lead to complications like nerve damage, kidney disease, and cardiovascular problems. Pre-diabetes, marked by elevated blood sugar levels, signals increased risk for type 2 diabetes, but lifestyle changes can often mitigate this risk, emphasizing the importance of monitoring blood sugar levels and adopting a healthy lifestyle.


Monitoring your blood sugar levels regularly empowers you to grasp how your body reacts to food, exercise, and medication, offering valuable insights into patterns and trends. This information enables informed decisions about your health, that can improve weight management, mood stabilization, and energy levels. By tracking glucose levels, you can identify which foods cause spikes or crashes.

Source: Harvard Health Publishing - Controlling Your Blood Sugar



Though continuous glucose monitors are intended for people with type 2 diabetes, this device, will now be available for those without diabetes who wish to know how their diet and physical activity affect their blood glucose levels. CGMs offer accurate and real-time readings, allowing for precise management of blood sugar levels. These devices are portable and easy to use, making it convenient to monitor your blood sugar. This information empowers individuals to make daily decisions about medication dosage, physical activity, nutrition, or encourage someone to see a doctor. If not taken seriously, chronic high blood sugar can damage organs or if too low can present as dizziness, sweating or fatigue.

Source: National Institute of Diabetes and Digestive and Kidney Diseases - Blood Glucose Monitoring


What’s the downside?


People who have healthy blood sugar fluctuations may end up unnecessarily worrying about normal blood sugar levels. NYU endocrinologist Michael B Natter, MD believes that there should be more guidance and an appropriate diagnosis given by a medical professional. People without diabetes or are not prediabetic may misinterpret glucose values. “There is certainly a downside to too much data”. Dr. Natter explains that continuous glucose monitors are not the same a finger stick or blood draw. A CGM does not measure the hemoglobin A1C over an extended period but instead measures the flux of glucose in the space between the blood cells. It is important to note, the device is not intended for those that have severe low blood sugar or “hypoglycemia”, which can be life threatening. The over-the-counter monitor is also not for people who are seeking to manage the dosage of their insulin. While this device approved to be over the counter, some doctors are concerned about the ethical issue due to some major price barriers.

Source: NYU Langone Health News Hub- Patient Care. March 11, 2024



The approval of the first over-the-counter continuous glucose monitor marks a significant advancement in health management. While offering valuable insights into blood sugar levels, it also highlights the importance of guidance from healthcare professionals for safe and effective use. By combining observation of blood glucose trends with informed medical advice, individuals can take proactive steps towards better health, paving the way for a future where monitoring blood sugar levels becomes a routine aspect of holistic health management.



Additional Resources:

 

American Diabetes Association https://www.diabetes.org/

Journal of Medical Internet Research https://www.jmir.org/

National Institute of Diabetes and Digestive and Kidney Diseases https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems

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