Lilly to integrate Dexcom CGM into personalized diabetes devices
Eli Lilly and Dexcom announced a global commercialization agreement to integrate DexCom’s continuous glucose monitoring devices into a personalized diabetes management system currently in development to advance the treatment of diabetes, according to a press release from the companies.
The nonexclusive agreement with Dexcom will build on Lilly’s efforts to provide a comprehensive system that integrates connected insulin delivery devices, software and analysis to equip people with type 1 and type 2 diabetes and their health care providers with personalized information and guidance to help simplify diabetes management, according to the release.
“Even with all of the advances in diabetes technology, insulin therapy is still overwhelming and complex,” Mike Mason, senior vice president of connected care and insulins for Lilly Diabetes, said in the release. “We’re excited to include Dexcom’s technology in the solutions we deliver to people with diabetes to help improve health outcomes by delivering actionable insights in one connected system. As we integrate our expertise and insights with those from our partners, like Dexcom, we are aiming to not only transform the way we develop and deliver medicine, but to transform how people manage their diabetes.”
The personalized diabetes management system in development will include both pen- and insulin pump-based platforms, according to Lilly. The pen-based platform will integrate personalized data from a prefilled, disposable insulin pen with data from glucose-sensing technologies into a compatible software application. Personalized data are transferred from the pen via an optional attachment.
The pump-based platform in development, which is a hybrid closed-loop system, will use integrated devices — an insulin pump, CGM and a dedicated hand-held controller or smartphone application that controls the system — to automate insulin dosing.
“CGMs provide people with diabetes and their health care team with important, real-time data that can help alleviate the burden of diabetes management, including overall glucose level trends and information on time spent in target blood glucose range,” Rick Doubleday, executive vice president and chief commercial officer of Dexcom, said in the release. “We’re looking forward to expanding our collaboration with Lilly as we integrate our technology into their system and believe it will help reduce some of the complexity that can come from managing diabetes every day.”
The announcement follows several recent FDA marketing authorizations designed to make devices more interoperable for people with diabetes. On Friday, the FDA announced that it authorized marketing of the Tandem Diabetes Care Control-IQ interoperable, automated insulin dosing algorithm, the first dosing controller that can be used with other interoperable diabetes devices and allow people with diabetes to create a customizable automated insulin delivery system. The FDA authorization paves the way for integrated CGM systems and alternate controller enabled (ACE) infusion pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing system, also known as an artificial pancreas.
In September, the agency cleared Insulet to market its tubeless Omnipod DASH Insulin Management System as an integrated ACE insulin pump, allowing it to be part of an interoperable, automated insulin delivery system. The Omnipod pump was the second device to be classified under a new de novo premarket review pathway, a regulatory pathway for novel, low- to moderate-risk devices of a new type, according to the FDA. – by Regina Schaffer
Disclosures: Doubleday is executive vice president and chief commercial officer of Dexcom. Mason is senior vice president of connected care and insulins for Lilly Diabetes.