Memorandum

Roche, Diabeloop, and Dexcom AID system launches in Europe and Roche Diabetes Care Platform launches in the US – March 11, 2021

Hybrid closed-loop system with Roche’s Accu-Chek Insight pump available in Germany, Spain, Italy, and the Netherlands with launch in Switzerland “soon”; Roche Diabetes Care Platform with "advanced pattern tracking" available for US providers

Roche/Dexcom/Diabeloop AID system now available in Germany, Spain, Italy, and the Netherlands

This morning, Roche told us that that its Accu-Chek Insight insulin pump with Diabeloop’s DBLG1 automated insulin delivery algorithm has officially launched in Germany, Spain, Italy, and the Netherlands. Over email, Roche also confirmed that the Accu-Check Insight + DBLG1 system will be available in Switzerland “soon.” Today’s announcement is in-line with previous expectations to launch in “early 2021” and comes less than two weeks after Roche and Diabeloop announced the successful integration of Roche’s Accu-Chek Insight pump with Diabeloop’s algorithm and just a few months after the partnership was first announced in December 2020. It’s great to see more systems taking advantage of so much progress in algorithms and software that are driving the closed loop.

As a reminder, Roche and Diabeloop have partnered with Dexcom to use the G6 CGM in the Accu-Chek Insight + DBLG1 hybrid closed loop system. A couple weeks ago, in a related announcement, Roche focused in on the Accu-Chek Insight pump’s compatibility with pre-filled NovoRapid PumpCart cartridges, as well as the ability for users to set “very low” basal rates (down to 0.2 U/hour). In particular, Roche highlighted that the AID integration makes Accu-Chek Insight the first pump with a pre-filled cartridge that is a part of a hybrid closed loop system, potentially a differentiator for some patients. Roche’s Accu-Chek Insight pump has been available in Europe since 2014; although it remains far behind Medtronic in terms of market share, it will be far more competitive with closed loop capability. On the algorithm side, Diabeloop’s DBLG1 algorithm incorporates predictive low-glucose suspend, basal rate adjustment automation, and automatic correction boluses and is housed in a locked-down handset. Diabeloop has already launched its DBLG1 algorithm with the Kaleido patch pump in a limited launch in France and, as of June 2020, was working to expand into the German market, according to management.

Roche’s long-awaited entry into the AID field comes at an increasingly competitive time in the European market with Medtronic’s MiniMed 780G already available in 26 countries and Tandem aiming to launch Control-IQ in 25 geographies by the end of 2021. Today’s announcement also marks a potential turning point for Diabeloop by bringing its algorithm into some of Roche’s largest OUS markets. Diabeloop has also recently secured partnerships with SFC Fluidics and Terumo toward its aim of offering AID systems in the US and Japan, respectively.

RocheDiabetes Care Platform launched in US

Today, we also learned that Roche has launched its RocheDiabetes Care Platform for providers in the US. According to Roche, this platform represents the “professional-facing key component” of its open ecosystem and integrates data from “more than 140” diabetes devices (e.g., connected BGMs). That platform then utilizes “smart algorithms” to create insights and identify patterns for providers. Of interest, Roche highlighted three functions of the platform in particular that we believe will have the potential to significantly improve clinical outcomes:

  • Pattern detection to identify “~20” clinically relevant patterns in patient data related to “insulin dosing, blood glucose monitoring behavior, time in range, and treatment adherence”;

  • Strip management for hospital pick-up (Roche can track BGM strip consumption via uploaded data and automatically deliver supplies to the hospital, (note: this is not currently available in the US); and

  • Home delivery utilizing the same tracking as for hospital pick-up, but with BGM materials delivered directly to patients’ homes (note: this is not currently available in the US). In a time when many patients are concerned about going to the hospital and looking to minimize time in pharmacies, we are sure patients will appreciate the option to have their BGM supplies delivered directly and automatically to their homes.

As Roche moves more into the digital health space and builds on its integrated Personal Diabetes Management (iPDM) platform it will be interesting to see how its RocheDiabetes Care Platform compares to other provider-facing software such as Glooko, Dexcom Clarity, and Tidepool Uploader

Close Concerns Q&A with Roche

  1. Geography: Does Roche have plans to bring this AID system to other markets in the near future? By the end of 2021?

    • Roche: We see potential in the new partnership with Diabeloop to advance the management of insulin pump therapy.

  2. Patients New to AID? Is Roche attracting new patients to pump therapy with this system or are the majority of current users prior Accu-Chek Insight users?

    • Roche: The integrated solution is especially attractive for people with diabetes on insulin therapy who have an interest in looping and want to improve therapy outcomes or experience more convenience on a daily basis. This for instance comprises: (i) people with diabetes in MDI therapy that are already using a Dexcom G6 and consider going on to an insulin pump; (ii) insulin pump users who are due for a new pump and are considering a hybrid-closed loop; (iii) people with diabetes using the Accu-Chek Insight insulin pump or other insulin pumps who also have CGM experience and are interested in automated insulin delivery (AID); or (iv) DIY users who would like to switch to a CE-certified automated insulin delivery (AID) system).

  3. Back to the US: Does Roche have plans to come back to the US pump market?

    • Roche: The US is important for our insulin delivery business as such is in focus. At this point in time, we cannot disclose any timelines or development activities.

  4. Priorities: Where does supporting this AID system fall in Roche’s priorities compared to other existing offerings like blood glucose meters and stand-alone pumps?

    • Roche: For more than three decades, we have been committed to supporting people with diabetes with differentiating insulin pump technology. Whereby, we aim to give people with diabetes choice so that they can select the best pump to suit their needs. Together with Diabeloop, we now embark on our journey of automated insulin delivery exploring new ways to advance management of insulin pump therapy. The partnership will create new opportunities to lower the burden for people with diabetes and to improve therapy outcomes.

  5. Algorithms and other follow up: Is Roche interested in partnering with other algorithm and CGM companies moving forward? How does this launch impact Diabeloop’s other partnerships and priorities moving forward?

    • Roche: We firmly believe that the integrated Personalized Diabetes Management (iPDM) in an open ecosystem is the future. Diabetes management solutions connecting to and interacting with each other will improve therapy outcomes and advance value-based care. We know that we cannot achieve this on our own. By building on our own strengths and expanding our offerings through partners, we embrace our vision to bring innovation to people with diabetes helping them to experience true relief. Please do understand that we cannot comment on further plans.

 

--by Hanna Gutow, Albert Cai, and Kelly Close