Abbott and Tandem plan to integrate FreeStyle Libre CGM data with t:slim X2 insulin pumps – October 15, 2019

Companies still exploring options – will this start with FreeStyle Libre 2 iCGM (under FDA review)? Can Tandem use FreeStyle Libre 2 readings for Control-IQ hybrid closed loop?

Abbott and Tandem announced plans today to develop and commercialize products that integrate a “next generation” FreeStyle Libre CGM with Tandem’s insulin pumps. The companies are still “exploring” options and are discussing technical details and commercial plans, which means this is a precursor to a formal commercial partnership announcement.

The announcement strongly emphasizes pump-CGM interoperability across companies, and this marks the second pump partner for Abbott’s FreeStyle Libre after Bigfoot (July 2017) and the second CGM partner for Tandem after Dexcom (5+ years ago – dating back to G4 Platinum). Tandem’s t:slim X2 was cleared as the first interoperable ACE Pump in February, and that clearance includes an indication to communicate with compatible iCGMs. Dexcom’s G6 is the only iCGM for now, though Abbott’s FreeStyle Libre 2 has been under FDA review as an iCGM since earlier this year; is clearance near?

Today’s announcement is broad, so we can only speculate on what a potential Tandem t:slim X2 pump-FreeStyle Libre CGM integration would look like:

• Will the FreeStyle Libre 2 iCGM send high/low alarms to a Tandem pump screen, prompting a user to scan with their phone or reader to see the real-time value/trend?

• Could Tandem integrate FreeStyle Libre 2 into Basal-IQ, offering predictive low glucose suspend with both Dexcom and Abbott sensors?

• Could the FreeStyle Libre 2 iCGM be integrated into Tandem’s Control-IQ hybrid closed loop, driving automated insulin delivery like Dexcom’s G6 (currently under FDA review)? Is such an integration contractually possible, considering Dexcom owns the Control-IQ algorithm? Would Tandem/Abbott use another AID algorithm to build a separate hybrid closed loop?

• Will Tandem and Abbott need to wait for a “next generation” FreeStyle Libre 3 that transmits real-time data continuously to the pump screen, rather than requiring a user to scan? Or is the US version of FreeStyle Libre 2 technically capable of pushing real-time CGM to the pump screen?

• Will Tandem wait to integrate FreeStyle Libre until the t:sport patch-like pump becomes available in late 2020, as that will include a wireless handheld/smartphone app to scan a FreeStyle Libre sensor? (We don’t imagine the current tubed Tandem pump would be used to scan an arm-worn FreeStyle Libre sensor – you’d need a long infusion set!)

Specific product details will clearly emerge over time, assuming this progresses to a formal R&D/commercial agreement.

Overall, this news is a terrific sign of continued industry momentum toward interoperability – enabling users to mix-and-match various companies’ pump and CGM devices to suit their needs, and giving industry and FDA the regulatory and business flexibility to combine components and to bring them to market quickly.

Abbott now joins Dexcom in having multiple pump partners, alongside a growing list of smart pen partners for both companies – see the table below for an insulin delivery partnership roundup for all four CGM companies. This news comes just one day following Abbott’s exciting partnership with Omada focused on type 2 diabetes. We view this as very positive for Abbott particularly if the association with automated insulin delivery (AID) emerges; the improvements in Time in Range associated with AID have been very positive for patients (and HCPs); over time, we believe all type 1s and all type 2s on MDI should have the opportunity to be on AID.

Tandem has had an eventful year after presenting fantastic Control-IQ/G6 pivotal trial results at ADA and submitting it to FDA; launch of its highly-anticipated hybrid closed loop system is targeted between now and the end of this year.

CGM & Insulin Delivery Partnerships

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

Close Concerns’ Questions

Q: When will Abbott and Tandem launch their first integrated product? Could we see this in 2020? Will the FreeStyle Libre-integrated Tandem pump have some automation (Basal-IQ or Control-IQ), or start with CGM display on the pump screen?

Q: When will FreeStyle Libre 2 obtain FDA clearance? Will it obtain iCGM labeling? Will the product have different communication features in the US – e.g., ability to continuously transmit real-time data and alarms to pump screens?

Q: Will Tandem’s Control-IQ obtain de novo FDA clearance as an iAlgorithm/ iController? Or has Tandem gone the traditional PMA route with the algorithm? Will Control-IQ be compatible with any iCGM? Or does Dexcom’s ownership of this algorithm prevent Tandem from using it with other iCGMs?

Q: Beyond the upside of choice, how will players creatively address the challenges of interoperability – e.g., customer support, commercialization, business models, adverse event reporting, etc.?

Q: Will pivotal trial data from one interoperable permutation – e.g., Tandem/ Dexcom/Control-IQ – translate to another component iteration? It certainly will from a regulatory perspective, and what about a reimbursement perspective? What about user experience and real-world data – will different components drive different outcomes? What about an HCP perspective?

--by Adam Brown and Kelly Close