Over-the-counter or prescription CGM: which one fits you?

What changed in 2024

In March 2024 the FDA cleared the first over-the-counter continuous glucose monitor, the Dexcom Stelo. The agency described it as intended for adults 18 and older who do not use insulin, such as people with diabetes managed with oral medicines and people without diabetes who want to understand how diet and exercise affect their blood sugar.

Each sensor can be worn for up to 15 days and sends readings to a smartphone app. The FDA was explicit about one limit: the system is not for people with problematic hypoglycemia, because it is not designed to alert users to that potentially dangerous condition.

How prescription CGMs differ

Prescription CGMs have been used in diabetes care for years. The National Institute of Diabetes and Digestive and Kidney Diseases notes that they benefit people who need insulin most, especially when worn every day, and can reduce low-glucose emergencies and finger sticks.

Prescription systems typically offer real-time alarms for high and low glucose, closer integration with insulin pumps and clinic software, and in some cases longer-lasting or implantable sensors. Because they are prescribed for medical management, insurance may cover them for people who meet plan criteria.

Side-by-side

• Who it is for: OTC is for adults not on insulin; prescription is for insulin users and people with diabetes who need closer monitoring
• Low-glucose alerts: OTC devices are not designed for this; prescription devices commonly provide them
• Prescription needed: no for OTC; yes for prescription models
• Insurance: OTC is usually self-pay; prescription CGMs may be covered when criteria are met
• Data review: OTC data are shown in a consumer app; prescription data are often shared with your diabetes care team
• Medical decisions: the FDA says not to make medical decisions from OTC readings without talking to a clinician

Who should not rely on an OTC device

If you use insulin, take a sulfonylurea or another medicine that can cause low blood sugar, or have had episodes of hypoglycemia, an OTC device is not the right tool. You need a system that alerts you to lows and a clinician managing your diabetes.

The same applies if you are pregnant or have a condition that makes glucose unpredictable. Talk to your doctor about a prescription CGM instead.

Where an OTC-style CGM can help

For adults with prediabetes, insulin resistance, or a family history of type 2 diabetes, two weeks of continuous data can be eye-opening. You can see how a particular breakfast, a late dinner, a poor night's sleep or a walk after eating changes your curve. The CDC estimates that more than 2 in 5 American adults have prediabetes, and it often goes undetected.

That said, evidence that CGM use improves long-term health in people without diabetes is limited. A CGM is a learning tool. Its value comes from what you change because of it.

Readings are estimates, not lab values

All CGMs measure glucose in the fluid between cells rather than in blood. NIDDK describes this as very similar to blood glucose, but readings can lag behind rapid changes, such as right after a meal or during exercise, and individual sensors vary. NIDDK advises confirming with a finger-stick meter if a reading seems wrong.

A single high spike is rarely meaningful on its own. Patterns across several days tell you much more. A CGM also does not diagnose diabetes; that still relies on lab tests such as A1c and fasting glucose.

Why add a clinician?

Buying a sensor is easy; making sense of 14 days of curves is harder. Many people end up anxious about normal post-meal rises or miss the patterns that matter. With HealifyMD, a clinician first checks that a CGM suits you, then reviews your glucose data alongside your labs, medicines, sleep and activity, and gives you a written summary with practical next steps.

The HealifyMD CGM is $189 one-time (one 14-day sensor, clinician visit included), with no membership fee, and your price is confirmed at the eligibility review. Labs are priced separately. If your history points to diabetes care with insulin, your clinician will direct you to the right prescription setup through your regular care team.