pharmaphorum March 6, 2024
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...