FDA clears first OTC glucose biosensor, from Dexcom

Adults in the US who want to measure their blood glucose levels using a wearable sensor will soon be able to buy one over-the-counter (OTC) for the first time.

The FDA has cleared Dexcom’s Stelo as the first continuous glucose monitoring (CGM) device that does not need a prescription, which can be used by diabetics on oral medications, as well as non-diabetic individuals who “want to understand how diet and exercise can impact blood sugar levels,” according to the regulator.

Stelo should not be used by anyone who needs insulin or people who are at risk of low blood sugar levels (hypoglycaemia), according to the FDA, which said the simplified version of a prescription Dexcom device is not designed to alert users of this “potentially dangerous condition.”

It takes the form of a patch with a small needle that pierces the skin and is worn on the back of the arm for up to 15 days, communicating glucose readings to a smartphone.

Dexcom is focused on its applications in the type 2 diabetes market, noting, for example, that it provides an option for people who don’t have insurance coverage for CGM – which, according to the company, includes a lot of diabetics who don’t need insulin.

As acknowledged by the FDA, however, Stelo could also find a market among a growing number of healthy people. Some may want to use CGM to spot early signs of abnormal glucose regulation that could be a warning factor for diabetes, while others who are simply interested in health and fitness may want to add glucose monitoring to the increasing array of health variables measured using wearables.

Other companies have specifically targeted non-diabetic users, including Abbott, which launched a wearable consumer CGM under the Lingo brand earlier this year in the UK, along with a coaching app.

The availability of an FDA-approved OTC device could also reduce the risk that individuals may unwittingly buy a falsified or unapproved device online. Prescription CGMs can often be seen offered for sale without a prescription on e-commerce sites at knockdown prices, raising questions about their quality and/or authenticity.

Dexcom has said it intends to launch Stelo in the summer, but has not yet revealed its pricing plans for the product. Typically, a patient paying out of pocket for a prescription CGM would be on the hook for around $175 per month, while an insurance co-pay is in the region of $50. In the UK, Lingo has launched at a retail price of £89 ($113) for one two-week sensor and £300 for four.

There are more than 25 million type 2 diabetes patients in the US who do not use insulin, and Dexcom hopes that Stelo could be used to help them understand what their normal blood glucose range is, and how levels are affected by certain foods and activities, so they develop healthier habits.

“Dexcom was the first to connect CGM to multiple insulin delivery devices, the first to connect CGM to a smartphone, the first to replace fingersticks for treatment decisions, and now is creating a new category by bringing the first glucose biosensor cleared for use over-the-counter,” said Jake Leach, the company’s chief operating officer.

“Based on our experience serving people with type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind.”