Continuous Glucose Monitors (CGMs) are devices that track glucose levels throughout the day and night. They offer a more comprehensive view of glucose trends compared to traditional fingerstick methods. Many people are interested in whether these devices can be purchased without a prescription.
Understanding Continuous Glucose Monitors
A Continuous Glucose Monitor (CGM) is a system designed to continuously measure glucose levels in the body. It consists of three main components: a small sensor, a transmitter, and a receiver or smartphone app. The sensor is typically inserted just under the skin, often on the arm or abdomen, where it measures glucose in the interstitial fluid, which is the fluid surrounding cells.
The transmitter sends this data wirelessly from the sensor to a receiver, which can be a dedicated device, a smartphone, or even an insulin pump. This allows individuals to see their glucose levels in real-time, observe trends, and understand how factors like food, exercise, and sleep affect their glucose. Historically, CGMs have been used by individuals with diabetes to manage their condition, but their use has expanded to include those interested in general health monitoring.
Over-the-Counter CGM Availability
The availability of Continuous Glucose Monitors without a prescription has recently expanded. In March 2024, the U.S. Food and Drug Administration (FDA) cleared the Dexcom Stelo Glucose Biosensor System as the first over-the-counter (OTC) CGM. This device is intended for individuals aged 18 and older who do not use insulin, including those with diabetes managed by oral medications, or people without diabetes who wish to monitor how diet and exercise influence their blood sugar. The Dexcom Stelo provides continuous glucose values every 15 minutes to a smartphone app, with each sensor wearable for up to 15 days.
Following Dexcom Stelo, Abbott also received FDA clearance for two OTC CGMs: Lingo and Libre Rio, though Libre Rio has not yet been commercially launched. These devices are approved for general wellness or for individuals not on insulin therapy. They typically do not provide alerts for problematic hypoglycemia, distinguishing them from prescription-only CGMs used for intensive diabetes management.
Obtaining a Prescription CGM
For individuals requiring intensive glucose management, especially those using insulin or experiencing problematic hypoglycemia, Continuous Glucose Monitors typically require a prescription. These prescription CGMs, such as the Dexcom G7 and FreeStyle Libre 3, provide important data for medication adjustments and preventing glucose fluctuations. The process involves consulting a healthcare professional who assesses specific medical needs, such as type 1 or type 2 diabetes requiring insulin, or frequent high or low blood glucose levels.
Once a prescription is issued, individuals can navigate insurance coverage, which often covers these devices for diagnosed medical conditions. Prescription CGMs offer features like real-time alarms for high or low glucose levels and integration with insulin pumps, which are important for precise diabetes management. These devices remain prescription-only due to their role in important medical decision-making and the need for medical supervision to interpret data and adjust treatment plans.
Choosing the Right CGM
Deciding between an over-the-counter and a prescription Continuous Glucose Monitor depends on individual health goals and medical circumstances. For those interested in general health awareness, understanding dietary impacts, or managing type 2 diabetes without insulin, an OTC CGM like Dexcom Stelo or Abbott Lingo could be suitable. These devices offer insights into daily glucose patterns and how lifestyle choices affect them.
Individuals with type 1 diabetes, those on insulin, or those prone to severe hypoglycemia require the comprehensive monitoring and alert features of a prescription CGM. These devices help manage complex conditions and integrate with treatment plans under medical guidance. Consulting a healthcare professional is important to determine the most appropriate CGM system based on specific health needs, medical supervision, feature requirements, and considerations regarding cost and insurance coverage.