Memorandum

Insulet Partners with Abbott and Dexcom to Integrate CGMs into Omnipod Horizon– February 19, 2020

Integrations with FreeStyle Libre 2 and Dexcom G6/G7; Omnipod Horizon to launch by end of 2020, likely as an “iController”; confirms that FreeStyle Libre 2 has capability to drive AID

In a major splash on day 1 of ATTD 2020, Insulet today unveiled partnerships with CGM giants Abbott and Dexcom, announcing plans to integrate Abbott’s FreeStyle Libre 2 (still under FDA review) and Dexcom’s G6, and upcoming G7 (launch in 2021), into Insulet’s Omnipod Horizon hybrid closed loop system (launch by end of 2020). While the partnership with Abbott comes as a welcome surprise, Insulet’s commercial agreement with Dexcom has been expected, as the two companies have already been in collaboration for some time.

Insulet is Abbott’s third pump partner, following a pre-commercial partnership with Tandem in October 2019 and an agreement with Bigfoot in July 2017 – see below for a full rundown of all insulin delivery/CGM partnerships. Insulet and Abbott’s combined technology is set to become the first fully disposable integrated platform, and balancing both the timeline for Omnipod Horizon and FreeStyle Libre 2’s pending FDA approval, we could see a combined system by the end of the year. Notably, today’s press release also confirms, for the first time, that FreeStyle Libre 2 (and not a future generation FreeStyle Libre device) has the capability to drive an AID pump system. We have speculated for a while that this is the case, given that FreeStyle Libre 2 adds Bluetooth connectivity and real-time high and low alarms, even though it still requires users to scan to get glucose values. Despite this, it seems unlikely that FreeStyle Libre 2 will be integrated into Tandem’s recently launched Control-IQ system due to Dexcom’s ownership of TypeZero (developer of the Control-IQ algorithm precursor).

The pivotal trial for Omnipod Horizon has already begun (see JPM 2020) using Dexcom G6; thus, it’s no surprise to see the two companies formalize an agreement before commercial launch for Horizon. The dual-partnerships mean Horizon will be the first AID system with two interoperable CGM partners, all but guaranteeing that Horizon will be submitted to the FDA under the new class II, “iController” classification created by Tandem. Since the pivotal study is running with Dexcom G6, integration with FreeStyle Libre 2 will also give us a first look at how strict the FDA is with “plug-and-play” AID systems. The special controls for iControllers outline the reliability, device interoperability, cybersecurity, and clinical relevance requirements for an iController, but importantly, do not specify any performance standard (like iCGM) or require studies of a certain size/type. Most notably, clinical data is required to demonstrate clinical performance of the device “as appropriate, as determined by the FDA” – will the FDA require Abbott/Insulet to run another pivotal study?

Regardless of how strictly the FDA regulates the FreeStyle Libre 2 and Omnipod Horizon integration, it’s great to see the two companies form a partnership presumably at least several months in advance of Horizon’s launch. Even with regulatory approval, a “plug-and-play” AID system requires considerable planning around sharing device data, handling customer support, and sending supplies. To this end, we asked Abbott whether Horizon would be compatible with FreeStyle Libre 2 at launch (assuming FreeStyle Libre 2 has been approved as an iCGM by then), to which they responded, “In terms of timing, we’re working as quickly as possible to make the integrated system available.” With all the regulatory components in place, we are watching closely to see how manufacturers execute on these interoperable systems and how payers, providers, and patients respond – we imagine unexpected questions may emerge, with any systems so new as these. Additionally, it’s interesting to think about the impact of interoperability on HCP workflow; while we love the idea of people with diabetes having lots of choice, we do imagine this is going to lengthen conversations with HCPs and patients about “what is best” for them. Thankfully there are more resources emerging all the time for patients to assess various technologies, particularly DiabetesWise, that is run by leaders at one of the premier diabetes practices in the country, at Stanford University, where Dr. Korey Hood, Dr. Bruce Buckingham, Dr. David Maahs, Ms. Melissa Townsend, and other stars are at the helm.

CGM and Insulin Delivery Partnerships

CGM

Pump Partners

Smart Pen Partners

Abbott

Insulet
Omnipod Horizon hybrid closed loop system integration (February 2020); Horizon pivotal initiated at “the very end of December [2019]”, launch still on track for 2H20 (January 2020)

Bigfoot
Autonomy pump-based hybrid closed loop to launch “~2023” (November 2019)

Tandem
Not yet formalized partnership; FreeStyle Libre data to be integrated with t:slim X2 (October 2019)

Bigfoot
Unity titration system 510(k) submission targeted for “middle of 2020,” commercial launch expected by end of 2020 (January 2020)

Novo Nordisk
Smart pen launch in 2Q20 (November 2019)

Sanofi
Smart pen launch within the next few years (September 2019)

Dexcom

Tandem
Launched in January 2020; Control-IQ cleared by FDA as first iController (December 2019)

Insulet
Omnipod Horizon hybrid closed loop system integration (February 2020); Horizon pivotal initiated at “the very end of December [2019]”, launch still on track for 2H20 (January 2020); Cleared as an ACE Pump (September 2019)

Tidepool Loop
In observational study (July 2019)

Beta Bionics
1Q20 pivotal trial start for insulin-only iLet (July 2019)

Lilly
Potential 2021 launch of hybrid closed loop (July 2019)

Diabeloop
CE Marked, pilot launched in France (September 2019)

Cambridge
Several upcoming studies (February 2019)

Companion Medical
Launched (September 2019)

Novo Nordisk
Smart pen launch in 2Q20 (November 2019)

Lilly
Smart pen under FDA review as of April 2019

Sanofi via Onduo?
Smart pen launch within the next few years (September 2019); Sanofi discontinued operational involvement with Onduo (December 2019)

 

Medtronic

Tidepool Loop
Its Zeus iCGM is in its pivotal trial, and could work with other companies’ ACE Pumps via Tidepool Loop (June 2019)

Novo Nordisk
Smart pen launch in 2Q20 (November 2019)

Senseonics

Beta Bionics
1Q20 pivotal trial start for insulin-only iLet (July 2019)

Roche
Timing unknown (July 2019); Roche Accu-Chek Solo pump launched in Australia (January 2020)

 

*See our Automated Insulin Delivery landscape and CGM landscape for the status of some other CGM/pump players, such as Beta Bionics, Bigfoot, Lilly, etc.

Close Concerns’ Questions

  • When will FreeStyle Libre 2 see FDA clearance in the US?

  • Will Abbott CGM data be viewable real-time in Horizon’s app? Will the CGM data be included in reports generated by Horizon? Will Omnipod insulin data be viewable in Abbott’s reports? (Same questions were sent to Dexcom.)

    • Response from Abbott: “Yes, Abbott CGM data will be viewable in Insulet’s app and included in their reports. The Pod data will also be viewable in Abbott’s reports, including our LibreView reports for HCPs.”

  • Will there be any collaborative efforts between Insulet and Abbott/Dexcom beyond the integration (e.g., co-marketing)?

  • What are the financial terms of the deals with Insulet (if any)?

  • Has any work on the integration between FreeStyle Libre 2 and Omnipod Horizon begun yet?

  • Will FreeStyle Libre 2 integration be available at the time of Horizon launch?

  • What will the FDA require to have FreeStyle Libre 2 and Dexcom G7 integrate with Horizon?

  • How will smartphone control and the patch pump form factor differentiate itself from other AID offerings (e.g., Control-IQ, MiniMed 780G)?

 

--by Rhea Teng, Albert Cai, and Kelly Close