FDA Clears DreaMed's MODI App for Personalized Insulin Dose Adjustments in Type 2 Diabetes
核心洞察
DreaMed Diabetes (搜索) received FDA clearance for MODI (搜索), a prescription app that gives adults with type 2 diabetes (搜索) personalized insulin dosage recommendations on their phones.
The app analyzes glucose and insulin therapy data to adjust dosing between clinic visits without requiring physician pre-set dosages or approval of each recommendation.
About 85% of insulin users rely on injections, more than eight million people in the U.S., yet dosing technologies have mainly targeted type 1 pump users.
DreaMed Diabetes (搜索) has received FDA clearance for MODI (搜索), a prescription-only application that analyzes blood glucose levels and insulin therapy data to deliver personalized insulin dosage adjustment recommendations to adults with type 2 diabetes (搜索) directly on their mobile phones. The clearance covers use without physician approval for each individual recommendation, a design choice aimed at closing the gap between clinic visits.
Dosing guidance between clinic visits
MODI (搜索) analyzes blood sugar patterns and treatment data and returns personalized dosing recommendations to patients, including in the intervals between appointments. The app does not require physicians to pre-set individual dosages or to approve each recommendation, which the company says could reduce the workload tied to routine insulin adjustments.
"Today, we can monitor glucose levels continuously, yet insulin treatment is often adjusted only once every few months. Data alone does not improve patient health; the real value lies in transforming that data into timely, personalized recommendations," said Eran Atlas, co-founder and CEO of DreaMed Diabetes (搜索). "MODI (搜索) enables millions of people with Type 2 diabetes (搜索) to receive data-driven guidance between doctor visits, bringing the benefits of advanced diabetes care technologies to patients who use insulin injections."
An injection-first population left behind
Roughly 85% of insulin users rely on injections, representing more than eight million people in the United States alone, according to the company. Many of these patients do not reach recommended blood sugar levels, and months can pass before a scheduled doctor visit brings an adjustment to their insulin dosage.
Advanced insulin-dosing technologies have been developed primarily for people with type 1 diabetes who use insulin pumps. For patients with type 2 diabetes (搜索) who depend on injections, options have remained more limited, the gap MODI (搜索) is intended to address.
Origins at Schneider Children's Medical Center
DreaMed was founded in 2014, emerging from technology initiatives at the Institute for Endocrinology and Diabetes at Schneider Children's Medical Center (搜索), part of the Clalit Group (搜索). The company is based in Kfar Saba and employs 30 people, all in Israel.
Active co-founders include Prof. Moshe Phillip, head of the Diabetes Institute and chairman of DreaMed; Atlas, who serves as CEO; Prof. Revital Nimri, chief medical R&D officer; and Ido Muller, director of algorithms and data science.
Naming honors Modi Amir
The application is named in memory of Modi (搜索) (Mordechai) Amir, a 67-year-old technology professional from Kfar Aza who was killed on October 7. The connection between the Amir family and DreaMed was established through the "Next October" memorial initiative, founded by Izhar, Hila, and Ofir Shay in memory of their son and brother, Yaron, who was killed in battle defending Kerem Shalom on October 7. With the family's consent, DreaMed named the application after Modi, and the name was also used in the company's FDA registration.