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)