Lilly begins Phase 1 study of automated insulin delivery system

By Dave Muoio
04:33 pm

Indianapolis-based pharmaceutical Eli Lilly and Company announced this week that the first Type 1 diabetes patient has been dosed in a feasibility study of the company’s investigational Automated Insulin Delivery (AID) system.

The company’s hybrid closed-loop platform consists of an insulin pump with a dedicated controller for system inputs, a dosing algorithm, and a continuous glucose monitor (CGM). Each component of the AID system works together to automatically adjust insulin infusion rates to help patients keep their blood sugar level within a specified range, according to the company, and will be offered alongside a companion app for patients’ smartphones.

To test the safety and functionality of the system, Eli Lilly’s study aims to provide 30 Type 1 diabetes patients with the AID system for approximately 12 to 18 days. Along with recording the number of participants who show a decrease, suspension or increase of insulin delivery within four hours of a challenge, the researcher will be looking to see how many participants resume the system’s automatic mode once they have restored CGM connectivity. This will be a single site trial, and is expected to conclude in April.

The AID system is one of two platforms currently under works for Eli Lilly’s Connected Diabetes Ecosystem, with the other being an integrated insulin management system. This offering consists of a connected, glucose-sensing insulin pen and a software component designed to better deliver personalized dosage recommendations. Pending approval, the company said that it hopes to have these two offerings available to patients within the next two or three years.

“All aspects of the Connected Diabetes Ecosystem are being developed with as much flexibility as possible,” Matthew Clemente, chief technology officer, Lilly Connected Solutions Platform, Delivery and Device Research and Development, told MobiHealthNews. “Lilly is working with world-class partners to integrate the system into clinical workflows and disease management systems to support an open architecture where possible. The tools within the Connected Diabetes Ecosystem, including both the automated insulin delivery system and integrated insulin management system, will help make it easier for patients and healthcare professionals by organizing and analyzing data that would otherwise need to be evaluated manually."


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