Drugs and FDA
FDA clears DreaMed’s MODI insulin dosing app for adults with type 2 diabetes
MODI received FDA 510(k) clearance to provide insulin dose recommendations for adults with type 2 diabetes using basal insulin or multiple daily injections.
The FDA has granted 510(k) clearance to DreaMed Diabetes’ MODI, a mobile app that uses continuous glucose monitoring (CGM) patterns and insulin information to make personalized insulin dose recommendations for adults with type 2 diabetes, Healio reported. MedCity News said MODI is intended for people using basal insulin and those who take multiple daily injections of fast-acting insulin. It must first be prescribed by a physician, according to MedCity News.
According to Healio, the app analyzes users’ glucose patterns and insulin information without requiring a health professional to configure settings or approve recommendations. MedCity News reported users can make adjustments without a provider reviewing each one. Healio said MODI is being assessed in the 13-week, single-arm MODIUS trial, which is enrolling adults with type 1 or type 2 diabetes who require insulin. Its primary outcome is percent time in hypoglycemia with glucose of less than 54 mg/dL.
