KL lives with type 2 diabetes and takes metformin and a SGLT-2i to keep blood sugars on track. KL is making a significant lifestyle changes and wants to closely monitor the impact on glucose levels throughout the day. KL asked their provider about getting a continuous glucose monitor (CGM) sensor, but insurance won’t covers since KL is not on insulin and is not at risk for hypoglycemia.

KL has made monumental changes in their approach to food choices and is going to the gym at least three times a week to improve their overall health. They want glucose feedback throughout the day instead of an occasional finger stick.

With the FDA approval of the first OTC glucose sensor, Stelo, people like KL can  get more detailed information about blood sugar response and trends throughout the day.

Who benefits from the Dexcom Stelo?
The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin and wants to better understand how diet and exercise may impact blood sugar levels. Since it does not have low blood glucose alarms, this system is not for individuals at risk of hypoglycemia.

How Does it Work?
The Stelo Glucose Biosensor System uses a wearable sensor paired with an app installed on a user’s smartphone or other smart device to continuously measure, record, analyze, and display glucose values. The device is built on the Dexcom G7 platform, but it does not have alerts and alarms like the G7, and each sensor is made to last up to 15 days rather than 10.

The device transmits blood glucose measurements and trends every 15 minutes in the accompanying app. The company warns users to only make medical decisions based on the device’s output after talking to their healthcare provider.

Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. Adverse events reported in the study included local infection, skin irritation, and pain or discomfort.

Increased Access
Making glucose sensors available without a prescription expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider. The hope is that more individuals will have access to valuable information about their health, regardless of their access to a doctor or health insurance.

Drawbacks?
Since this is an out-of-pocket expense, the cost may be prohibitive for some individuals. In addition, having all this data can lead to information overload, especially if the individual is trying to make sense of the numbers without coaching from a healthcare professional.

Cost and Availability
Dexcom plans to make Stelo available this summer. The company hasn’t provided pricing estimates but said the device would be competitive with Dexcom’s current prescription-required device, the Dexcom G7.