FDA clears first insulin-dosing app covering both Type 2 injection regimens
DreaMed Diabetes received FDA 510(k) clearance for MODI, a mobile app that uses continuous glucose monitor data to generate insulin dosing recommendations for adults with Type 2 diabetes. The company says it is the first FDA-cleared app that can automatically adjust doses for patients on both basal-only insulin and more complex multiple daily injection (basal-bolus) regimens, rather than basal-only tools alone. Dose changes can be made between office visits without a clinician approving each individual adjustment.
Why it's notable: Type 2 patients on multi-injection insulin regimens are common and hard to titrate safely between visits, so extending automated dosing support to this group could ease a significant chronic-care workload for primary care and endocrinology.