Memorandum

Lilly and Dexcom Plan to Integrate Dexcom CGM with Lilly’s Connected Pens and AID Systems – December 16, 2019

Lilly has been using Dexcom CGM in clinical trials of both systems; no updates on Lilly’s smart pen or hybrid closed loop progress

In a short press release, Lilly announced a non-exclusive agreement to use Dexcom CGMs in Lilly’s “personalized diabetes management system,” i.e., their smart pen and hybrid closed loop pump projects. The agreement comes as no surprise, as Lilly and Dexcom already had a non-exclusive agreement to use Dexcom CGMs in the first clinical trials with Lilly’s Connected Care projects.

Dexcom is Lilly’s first CGM partner that we know of, while Dexcom boasts an impressive list of pump and smart pen partners – see a full list table of insulin delivery partnerships for all four CGM companies below. With Control-IQ clearance just last week, partnerships with Tandem, Insulet, Tidepool, Beta Bionics, and Lilly, we could see 6+ (!) Dexcom CGM hybrid closed loop systems come to market in the next one to two years.

Lilly has had a smart pen submitted to the FDA since 1Q19, though we haven’t heard any updates since then, which is surprising. At Lilly’s Blogger Summit in 2018, the plan was to launch a full “Integrated Insulin Management” system, consisting of a dosage guidance app using Lilly’s dose capture devices, CGM, BGM, and other sensors (e.g., exercise). On the automated insulin delivery (AID) front, Lilly’s in-house pump/closed loop algorithm advanced to “phase 2” at the end of last year, with “phase 3” trials in 2020, and a potential 2021 launch (per 2Q19 remarks). While at the summit, launch was estimated as early as late 2019 or as late as late 2020, it sounds like launch will be later, and we encourage Lilly to take as long as it needs. We aren’t actually used to hearing device pipeline advancement characterized the same way as drug pipeline movement, e.g., phase 2, phase 3, and we’d like to check in with Lilly on this to make sure we have heard this correctly. Given the non-exclusive nature of the agreement, it seems likely that Lilly would submit its in-house pump through the ACE pump pathway and enable interoperability with other CGMs (FreeStyle Libre 2 is currently under FDA review as an iCGM) although we also speculate that thoughts on interoperability could change over time. Would Lilly do the same with the brand-new “interoperable automated glycemic controller” (iController) pathway for AID algorithms? We’re waiting and seeing.

CGM and Insulin Delivery Partnerships

CGM

Pump Partners

Smart Pen Partners

Abbott

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

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

Bigfoot
Unity titration system launch expected in 2021 (November)

Novo Nordisk
Smart pen launch in 2Q20 (November)

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

Dexcom

Tandem
Control-IQ cleared by FDA as first iController; launch by end of January 2020 (December)

Insulet
Horizon pivotal trial in 4Q19, launch in 2H20 (August); cleared as an ACE Pump (September)

Tidepool Loop
In observational study (July), aggressive goal to prepare FDA submission before end of 2019

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

Lilly
Potential 2021 launch of hybrid closed loop (July)

Diabeloop
CE Marked, pilot launched in France (September)

Cambridge
Several upcoming studies (February)

Companion Medical
Launched (September)

Novo Nordisk
Smart pen launch in 2Q20 (November)

Lilly
Smart pen under FDA review as of April

Sanofi via Onduo?
Smart pen launch within the next few years (September)

 

Medtronic

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

Novo Nordisk
Smart pen launch in 2Q20 (November)

Senseonics

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

Roche
Timing unknown (July)

 

*See our Automated Insulin Delivery landscape and CGM landscape for the status of some other CGM/pump players, such as Medtrum, POCTech, WaveForm, etc.

Close Concerns Questions

  • What is the launch timeline for Lilly’s smart pen? When is FDA clearance expected to come through?

  • How far along is Lilly’s hybrid closed loop system? Will Lilly submit the pump and algorithm as an ACE pump and iController?

  • How closely will Dexcom and Lilly’s devices be integrated? Will Dexcom CGM values be displayed on Lilly’s dosage guidance app?

  • Are there financial or marketing components to this agreement between Lilly and Dexcom?

  • What other partners is Lilly looking to work with? How much easier would it be to attract partners if Lilly submits its AID system as an ACE pump/iController?

  • Would the pivotal trial data from Lilly/Dexcom’s AID system be translatable to another CGM, e.g., FreeStyle Libre 2 or 3?

 

--by Albert Cai and Kelly Close