OPEN LETTER to:
• Robert M. Califf, M.D., Commissioner of Food & Drugs, USFDA
• Jeffrey E. Shuren, M.D., J.D. Director, Ctr for Devices & Radiological Health, US FDA
• Kellie Kelm, Ph.D, Director, Office of Health Technology 7, US FDA
• Yiduo Wu, Ph.D., Branch Chief, Office of Health Technology 7, US FDA
• Courtney Lias, Ph.D., Director, Office of Health Technology 3, US FDA
FROM: Joanne Milo, M.B.A., Type 1 diabetes (57+ years), diabetes community advocate, blogger
SUBJECT: FDA Mandate for Interoperability and End-User, Continuous, On-Device Access to Our Own CGM Data
Dear Dr. Califf,
News reports earlier this week of Dexcom potentially acquiring Insulet may help explain Dexcom’s reticence to support other algorithm and insulin pump companies developing Automated Insulin Delivery (AID) systems, as well as Dexcom’s ongoing collusion with the FDA to prevent people with diabetes from accessing their own CGM data under the pretense of cybersecurity.
If Dexcom acquires Insulet it is not hard to imagine a future where Tandem and other insulin pumps/algorithm providers are suddenly without a CGM partner. Companion’s acquisition by Medtronic in 2020 is a perfect case study: within months, Medtronic removed support for inPen’s Dexcom access in favor of their own CGM. With Tandem’s stock price down over 50% from last year, the next logical step would be for Abbott to acquire Tandem.
This would leave the only three insulin pump companies in the United States owned by CGM companies. The vision of an interoperable nirvana of iCGM, IAGC, and ACE Pump companies would evaporate overnight. Patient choice, innovation, and cost-effectiveness would be constrained. Companies like Ypsomed, Roche, Vicentra, Modular Medical, Sigi, Lilly, Luna, Beta Bionics, EOflow, Diabeloop, Sooil, and CamDiab would be left without CGM access and be doomed to failure.
Perhaps more seriously, as the recent baby formula debacle has demonstrated, the concentration of a critical FDA-regulated medical device system in a triopoly – Medtronic, Dexcom+Insulet, Abbott+Tandem – puts patients at risk if anything were to cause a disruption in one of these providers. Once again this is not a hypothetical risk, as Medtronic is currently under a warning letter, and Abbott and Dexcom are in a bitter patent dispute.
The solution to this problem is very simple: the FDA needs to stop treating people with diabetes as “black hat” hackers, forced to reverse-engineer access to their own CGM data. The reports on open-source AID systems show that these systems are safe and reliable, with outstanding/best results available across all AID solutions today. (https://www.thelancet.com/journals/landia/article/PIIS2213-8587(21)00267-9/fulltext)
The FDA’s current cybersecurity policy forces CGM providers to block end-user access to their own data; data which they can already see from their smartphones and use as they see fit to manage their diabetes. This is certainly not what FDA interoperability evangelists Courtney Lias and Stayce Beck envisioned. By the way, Dr. Beck now works for Dexcom, as Vice President of Clinical and Strategic Partnerships.
People with diabetes and the small companies trying to innovate in the AID space are very concerned by the prospect of an acquisition of Insulet by Dexcom. To address this and future possible anti-competitive actions, we urge the FDA to adopt a policy wherein people with diabetes are treated as friends, not foes; where they may securely access their own health data from their own devices.
Our ongoing discussions with Dr. Yidou Wu and Dexcom executives have been fruitless. We need your help, NOW!
With urgency …
Joanne Milo, Founder, TheSavvyDiabetic.com and LoopandLearn FB group (and my community of people with Type 1 diabetes, all seeking the best solutions to manage this extremely difficult and damaging disease)
Joanne,
Outstanding letter that could not be more timely. I hope the FDA responds appropriately to this and does so promptly!
Good comments Joanne.
I am going to forward this to my Congressman and Senators.
Nicely presented. It would be a tragedy to see innovation in this space dry up.
Thanks for being an advocate for the rest of us.
I 100% agree with this letter.
Thank you, Joanne, for your tireless efforts and for advocating for us in all aspects of T1D management.
Done
Thank you, Joanne, for keeping abreast of the whole Type 1 realm and working hard to being awareness and affect positive change!
I think that it could freeze out many other promising pump companies. We have Lilly on the verge of a new pump, Bigfoot still going forward, and several oversee pump supplies. it is a potentially bad deal all around.
Joanne – thank you for writing this important letter. As a fellow person with diabetes and also an innovator making diabetes devices (Timesulin, Bigfoot Unity, Luna Diabetes ), I share your grave concern that this has the potential to STOP innovation even further. As somebody who has dedicated myself to making new and innovative diabetes technology, within the constructs of companies and FDA regulation – I can share that it has already in a major way. Currently, new companies can’t develop any new advanced products that require real-time CGM data in partnership with the big two.
Companies like Luna and others like us, including some of the most well-known diabetes tech companies, want to work in partnership and use approved and existing methods to integrate data. We want to be able to run clinical trials to prove safety and efficacy and use CGM in authorized ways. We are not advocating there be a free for all. We believe it is the FDA that should determine what devices are safe and effective and that people with diabetes should be able to access their health data. However, those doors are shut and have been at least for the last two years since the last iCGM partnership was announced.
We are very thankful that alternative CGM technologies are coming from companies and leadership teams that welcome collaboration, secure & authorized access to data, and value innovation so that people living with diabetes have choices. We hope that organizations like JDRF, Helmsley, the SEC & FTC, and the FDA demand access to CGM so that new products reach people with diabetes, helping ensure people with diabetes live a safer, more balanced life with diabetes on their terms.
At Luna, we aren’t looking to start a battle – we are looking for partners that share our view that people with diabetes deserve access to the best technology possible. That companies like ours have a chance to innovate.
We invite the big two to work together with us and our fellow innovators.
/John Sjölund
Luna Diabetes CEO
Joanne – thank you for writing this important letter.
As a fellow person with diabetes and also an innovator making diabetes devices (Timesulin, Bigfoot Unity, Luna Diabetes ), I share your grave concern that this has the potential to STOP innovation even further. As somebody who has dedicated myself to making new and innovative diabetes technology, within the constructs of companies and FDA regulation – I can share that it has already in a major way. Currently, new companies can’t develop any new advanced products that require real-time CGM data in partnership with the big two.
Companies like Luna and others like us, including some of the most well-known diabetes tech companies, want to work in partnership and use approved and existing methods to integrate data. We want to be able to run clinical trials to prove safety and efficacy and use CGM in authorized ways. We are not advocating there be a free for all. We believe it is the FDA that should determine what devices are safe and effective and that people with diabetes should be able to access their health data. However, those doors are shut and have been at least for the last two years since the last iCGM partnership was announced.
We are very thankful that alternative CGM technologies are coming from companies and leadership teams that welcome collaboration, secure & authorized access to data, and value innovation so that people living with diabetes have choices. We hope that organizations like JDRF, Helmsley, the SEC & FTC, and the FDA demand access to CGM so that new products reach people with diabetes, helping ensure people with diabetes live a safer, more balanced life with diabetes on their terms.
At Luna, we aren’t looking to start a battle – we are looking for partners that share our view that people with diabetes deserve access to the best technology possible. That companies like ours have a chance to innovate.
We invite the big two to work together with us and our fellow innovators.
/John Sjölund
Luna Diabetes CEO
We need as much open innovation in the development of diabetes technology as currently exists. This technology is monumental in preventing the life threatening outcomes that we type 1 diabetes face. It is critical that the technological tools be as transparent and user friendly as possible to be able to serve our various members of the diabetes community. We are great full to the DYI technology innovators who have made available looping. What a huge difference this has made in controlling our disease. Please do not bind the hands of these innovators. Thank you Julie Bailey T1D
Thank you so much for excellent articles. Please send this to Patty Murray, Senator who is the chair of Health, Education, Labor and Pensions