The FDA has cleared DreaMed Diabetes's MODI app, a prescription tool that uses continuous glucose monitoring data to automatically recommend insulin doses for adults with type 2 diabetes. MODI is the first cleared app to optimize dosing for both basal-only and multiple daily injection regimens, targeting the 85% of U.S. insulin users who rely on injections. The app is named in memory of Mordechai Amir, who was killed in the October 7 terrorist attacks.
FDA clearance of the MODI application
- ▪The DreaMed Diabetes MODI application is the first FDA-cleared technology designed to automatically optimize insulin dosing for patients using both basal-only and multiple daily injection regimens.
- ▪The Israeli startup DreaMed Diabetes received FDA 510(k) clearance for MODI, a prescription mobile application that automatically optimizes insulin dosing for adults with type 2 diabetes.
- ▪The DreaMed Diabetes MODI application analyzes continuous glucose monitoring data to deliver personalized insulin dose recommendations directly to a patient's smartphone without requiring a healthcare provider to approve each adjustment.
Memorializing Mordechai Amir
- ▪The initiative Next October, founded in memory of Yaron Shay, paired DreaMed Diabetes with the family of Mordechai Amir to memorialize Amir through the naming of the MODI application.
- ▪DreaMed Diabetes registered the MODI application with the FDA in memory of Mordechai Amir, a 67-year-old Kibbutz Kfar Aza resident who was killed during the October 7 terrorist attacks.
Challenges in insulin therapy management
- ▪Traditional automated insulin dosing technologies have historically focused on type 1 diabetes patients using insulin pumps, leaving injection users with static dosages between periodic clinical appointments.
- ▪More than eight million people in the United States inject insulin daily, representing approximately 85% of all U.S. insulin users who rely on injections rather than insulin pumps.
- ▪Clinical inertia, fear of initiating insulin, and hypoglycemia risks often delay insulin treatment and optimization in type 2 diabetes, leading to a heightened risk of diabetes complications.
- ▪Delays in adjusting insulin regimens for type 2 diabetes patients, which often occur during episodic primary care visits, cost an estimated $7.3 billion.
Debatable claims
- ▪Allowing automated apps to adjust insulin doses without physician approval poses unacceptable safety risks
- ▪Digital decision support systems are an effective way to reduce type 2 diabetes complications
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