Dexcom has obtained an FDA clearance for its basal insulin dosing optimizing program, designed for adults with Type 2 diabetes using its continuous glucose monitors.
The company said its Smart Basal application—which aims to help a new user dial in a personalized background dose—is the first CGM-integrated approach in Type 2 diabetes for people taking a glargine U-100 long-acting insulin therapy.
“We understand that many people with Type 2 diabetes are apprehensive about starting basal insulin due to fears of hypoglycemia and the reality that it often takes months of trial and error to reach the right dose,” Peter Simpson, Dexcom’s senior vice president of innovation and sensor technology, said in a statement.
“Dexcom Smart Basal is designed to remove barriers to insulin initiation—giving healthcare providers the confidence to start their patients on basal therapy sooner and with greater ease,” Simpson said.
The program starts with an initial basal dose set by a clinician. Then, by analyzing glucose readings from its G7 wearable sensor, Smart Basal provides daily dose recommendations and reminders through the connected smartphone app—as opposed to the typical method of relying on a single fasting blood sugar reading.
In addition, the program will provide alerts and lower its recommendations if it logs any dips into hypoglycemia, also by using amounts set by the user’s healthcare provider.
Dexcom said the program will roll out to users and clinicians as part of the U.S. launch of its 15-day G7 sensors, which received an FDA clearance earlier this year. The company added that it is also working to secure regulatory green lights for Smart Basal internationally.