Tidepool partners with Lilly as part of Big Data Donation Project; insightful blog post addresses insulin access and conversations – March 1, 2018

Executive Highlights

  • Tidepool recently announced a partnership with Lilly to provide use of its Tidepool Clinical Study Platform and access to anonymized datasets from the Tidepool Big Data Donation Project. Lilly plans to use Tidepool’s datasets to advance the Lilly Cambridge Innovation Center’s efforts to develop innovative insulin delivery devices, algorithms, and mobile medical applications. Lilly is the second company to purchase access to patient-donated data, after Dexcom.
  • Tidepool wrote an extensive blog post announcing the news, mostly addressing Lilly’s role regarding issues of insulin access and affordability. When Lilly expressed interest in licensing Tidepool’s donated diabetes datasets, Tidepool engaged in discussions with several parts of the company, including Lilly’s “Insulin Access and Affordability” team and eventually highly-regarded Lilly Diabetes President (and Head of the US) Mr. Enrique Conterno to better assess Lilly’s position and provide feedback on the situation. Although Tidepool was ultimately disappointed with Lilly’s current stance and offered several recommendations to the company (clearly delineated in the post), CEO Howard Look characterized Lilly as “incredibly receptive to our feedback, at every level.” We hope to see this partnership not only advance technology and decision support, but also to expand access.
  • In line with Tidepool’s nonprofit-supporting and open source policies, 10% of the revenue from the Big Data Donation Project goes to diabetes nonprofit partners (over $80,000 so far!). Tidepool is also publicly posting short summaries of how each partner is using the data – see here. Overall, Tidepool expects to generate >$800,000 in revenue from the Big Data Donation Project in the coming months – an impressive way to sustain the non-profit, support the ecosystem, partner with large and grassroots nonprofits, and improve diabetes innovation.
  • Following the debut announcement last November, Lilly’s Diabetes Connected Care group has announced multiple partnerships and is truly on a role: Dexcom (December), Rimidi (December), and with Livongo (January). Trials are ongoing for hybrid closed loop (see here) and smart pen programs (see here) – both of these exciting programs are expected to launch in ~2019-2020, though a great deal will have to go well to make major progress on all these programs.

Tidepool CEO Howard Look recently announced in a blog post that Lilly will use its Tidepool Clinical Study Platform and purchase access to anonymized datasets as part of the Tidepool Big Data Donation Project. Lilly plans to use Tidepool’s diabetes datasets to help advance its development of novel insulin delivery devices, algorithms, mobile medical applications, and to explore new forms of insulin therapy. As noted in Tidepool’s blog post, given the fragile pump market, punctuated by Animas’s exit (and Roche’s in the US), it is now more important than ever for companies to invest in building creative insulin delivery devices, using data in smarter ways, and innovating on insulin therapy. In line with Tidepool’s very valuable open source philosophy, Lilly will be held to publicly sharing how it uses Tidepool’s datasets –Tidepool will be posting short summaries from partners here, which is fantastic for patients.

Lilly joins Dexcom as the second company to license Tidepool’s donated diabetes datasets. As emphasized in the Tidepool blog post, contributing to these datasets is entirely optional, and patients must opt in to do so (they can also easily opt out of data sharing at any time).

  • Dexcom is using CGM, meal, and insulin data to “develop insights that will help patients on multiple daily injections and pump therapy achieve better outcomes with less effort.” There has already been big praise from patients who appreciate the weekly informational emails from Dexcom Clarity about their data, and there is much more to follow (per Dexcom’s ATTD 2018 presentation).
  • Lilly is using the data sets to “develop new delivery devices, algorithms and mobile medical applications, which will provide … actionable insight for simpler, more effective diabetes management.”

Tidepool will continue to share 10% of the Big Data Donation Project proceeds with its diabetes non-profit partners, with >$80,000 in donations expected over the course of the upcoming months – that translates to a remarkable >$800,000 in revenue for Tidepool! Additionally, certain datasets will be available for free or at a substantially reduced cost to nonprofit, academic, and citizen-scientist researchers. The remaining proceeds help Tidepool remain a free software provider for the diabetes community. This project is an outstanding example of a program that drives a non-profit’s mission AND sustainability, along with driving needed innovation within the diabetes ecosystem. (For related reading, check out this short FasterCures blog post by Julien Rashid about how donating health data could be “the new altruism.”)

Tidepool released its first major analysis of patient data from the project in November, answering CGM-related questions like time-in-range and hypoglycemia by age. Tidepool published a very cool follow-up post during ATTD digging deep into insulin pump data. We look forward to seeing the data set expand, as it will drive more representative analyses and likely greater insights. Presumably machine learning could be deployed once the data set gets larger, teasing out even more patterns.

Following the debut announcement late last year, Lilly Diabetes has been very active on the Connected Care partnership front. This Tidepool news follows the start of the AID feasibility study with Dexcom (December); the Rimidi partnership (December) to develop provider-focused tools for the integrated insulin management system; and a collaboration with Livongo (January) to collaborate on real-world clinical/outcomes research. Trials are ongoing for both the hybrid closed loop (our report here) and smart pen programs ( here) – both systems are expected to launch in ~2019-2020 (~2-3 years from the December 2017 announcement). It’s exciting to see Lilly Diabetes’s previously-stealthy Cambridge Innovation Center, led by Dr. Howard Wolpert and Ms. Marie Schiller, continuing to drive forward on data, connectivity, and more effective insulin therapy.

Tidepool’s Take on Insulin Access and Affordability

  • Although Tidepool is looking forward to supporting the Lilly Cambridge Innovation Center’s exciting efforts, Mr. Look’s blog post is careful to acknowledge some disappointment in how Lilly has addressed insulin access and affordability. Tidepool engaged in conversations with other parts of the company coincident with working on the agreement, including Lilly’s “Insulin Access and Affordability” team. Ultimately, Tidepool was left “disappointed,” as it felt: (i) Lilly lacked clarity regarding the issues contributing to insulin affordability and access; (ii) Lilly could not clearly define an action plan to address these issues; (iii) Lilly did not demonstrate a commitment to improving insulin access and affordability; and (iv) Lilly lacked sufficient empathy for those affected by restricted insulin access and affordability.
  • The blog post acknowledges that Lilly was open to feedback, with a number of specific suggestions offered. Via email, Mr. Look emphasized that Lilly has been “incredibly receptive to our feedback, at every level.”
    • Educate the public on insulin access and affordability issues with a “clear and concise expression of what the issues are”;
    • Invest in search engine optimization and marketing so that people who Google “I can’t afford my insulin” are directed to resources provided by Lilly ( has a review of Patient Assistance Programs);
    • Support nonprofit efforts to help people understand how to gain access to affordable insulin and to lobby employers to provide access to health plans with low or no deductive for chronic disease medication;
    • Commit not to raise insulin prices and to release a lower-cost alternative;
    • Commit to releasing appropriate patents on rapid-acting biosimilar insulin.
    • Use a more human-centered approach to addressing issues, including writing in a clearer, more empathetic tone when describing problems or sharing changes – e.g., “This a real problem, and we would like to walk you through the steps we are taking to address it, including what we have learned from mistakes we’ve made in the past when trying to address the issues publicly.”
  • Tidepool commented that its recommendations regarding these critical issues have been the topic of several conversations and have escalated to the President of Lilly Diabetes, Mr. Enrique Conterno. It’s great to see Tidepool promoting actionable, transparent discussions and recommendations on access – even as this partnership is being announced. Hopefully, Lilly will continue to be receptive to the community’s feedback and work within the ecosystem towards improving insulin access and affordability.
  • We noticed at JPM last month that a majority of healthcare and pharma leaders avoided touching policy. For instance, even as representatives and senators on Capitol Hill debated his candidacy, we can’t recall a single mention of HHS Secretary and former Lilly executive Mr. Alex Azar and what he could do for drug prices and healthcare overall. More frequent and intentional dialogue between public and private (not to mention patients and providers!) would be excellent to see. 

Close Concerns Questions

Q: How will Lilly specifically leverage donated Tidepool data? Where does Lilly have big questions that Tidepool data can help with? Might the data be used to identify which patients need the most support, or perhaps which subgroups of patients are more likely to experiment with new technology? Will the data be used to identify critical gaps in care?

Q: Will Lilly use Tidepool’s Clinical Study Platform for its ongoing phase 1 safety/functionality study of its AID system? For the smart pen trial investigating missed meal boluses? Does Lilly plan to use Tidepool’s Platform for all future studies?

Q: How will Tidepool continue to press the issue of insulin affordability and access? How will Lilly respond? How will Lilly’s response affect Tidepool’s partnership moving forward? How long will Lilly have access to Tidepool data under the current agreement?

Q: Will Tidepool be more formally involved in Lilly’s insulin delivery devices when they come to market? We assume they would be compatible, given Lilly’s ecosystem focus.

Q: Might Lilly develop a diabetes coaching program in collaboration with Tidepool?

Q: How many Tidepool users share their data in the Big Data Donation project? How has this changed with this announcement, if at all? If Tidepool’s data set was ten times the size, what additional questions could be asked? What additional insights would be possible to generate?

Q: Where is the diabetes community most missing data? What are the biggest clinical and behavioral questions Big Data can help to address? What can Big Data NOT address in a meaningful way?


--by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close