Memorandum
Plans to integrate Diabeloop’s DBLG1 AID algorithm with Terumo’s Medisafe With insulin patch pump; Terumo secures exclusive distribution rights in Japan
This morning, Diabeloop announced a “joint development agreement” with Japanese manufacturer Terumo to integrate Terumo’s Medisafe With insulin patch pump and Diabeloop’s DBLG1 AID algorithm. Diabeloop’s closed-loop algorithm is CE-marked and already compatible with Dexcom G6 CGM and the Kaleido and Dana-i (SOOIL) pumps. As part of the development agreement, Terumo will get exclusive distribution rights for the final combined system in Japan, where Medisafe With is the only patch pump on the market. The press announcement also notes that both companies are “considering future distribution to other countries.” Dexcom recently secured regulatory approval for G6 (see 2Q20), but the device has not yet commercialized. Of note, Terumo is also Dexcom’s CGM distributor in Japan, potentially helping to streamline the process when a Diabeloop/Terumo AID system launches.
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As a reminder, Diabeloop’s DLBG1 algorithm runs on a locked-down Android controller and only requires patients to provide weight, daily insulin doses, and meal ratios for the system to operate. For users who want more fine-tuned insulin delivery, the system also offers glucose targets and customizable hypo/hyper thresholds. The system has been CE-marked for two years and as we learned at DTM last week, Diabeloop is “ready to launch our commercial release across Europe.” On the US front, Diabeloop launched a large clinical study in February 2020 to support an FDA filing as an iController – that trial has been suspended due to COVID-19 and we do not yet have information about the next steps there.
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We got our first look at Terumo’s Medisafe With patch pump at the Exhibit Hall at EASD 2019. The patch pump has three-day wear and consists of two pieces, a reusable component and disposable component. When used alone, the pump is controlled via a remote controller, but we assume the combined AID system will be entirely controlled from Diabeloop’s locked down Android controller similar to Diabeloop’s existing AID systems. Just last week, Terumo announced its Medisafe With pump received CE-marking. No updates were shared about launch timing in Europe, but according to the announcement, Terumo is initiating a “global product launch.”
--by Hanna Gutow, Albert Cai, and Kelly Close