My CGM, My Body, My Diabetes, MY DATA!

Diabetes Advocacy
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ADVOCACY UPDATE!

#WeAreNotWaiting Needs Your HELP!

Comment submissions to the FDA are closed next Thursday (July 7th) so DO NOT WAIT to show your support for #WeAreNotWaiting

INSTRUCTIONS:
** Tap on link: tinyurl.com/ct6n22

** Fill in the comment box with your message

** Select Option: Device Industry C0012

** Enter your email

** Tell about yourself: either Individual or Anonymous

** Check the box that you have read/understood

** Tap the GREEN Submit button

THAT’S IT! All in under 2 minutes!

Do you like continuous access to your CGM BG data so that your DIY Loop WORKS?! Do you know that we might lose that access with Dexcom G7 (they will not tell us) - Abbott Libre3 has never allowed access?

WE NEED YOU TO ACT … IT MATTERS!

Please join me in a letter-writing campaign to fill their inbox with our comments and concerns! NOW!

Suggested text:

“I live with insulin-requiring diabetes, an incurable chronic disease requiring continuous monitoring of blood glucose values and administration of insulin. It is imperative that access to my own devices remains possible. The ability to receive glucose values from my continuous glucose monitor and the ability to command my insulin pump to deliver insulin are already permitted and expected of me. In fact, if I don’t do these, I will die. So please do not let medical device manufacturers use cybersecurity as a pretense to prevent me from accessing my own devices.”

“When you put your name (or even if you post anonymously) consider including ‘pwd’ or ‘t1d’ or however you identify yourself as someone with diabetes, I.e. ‘Sally Smith, T1D’ so that they know our community has a voice”

If you do nothing else today, listen to my interview with Scott Benner and take action now, by letting the FDA know that taking away access to our data will do great harm AND asking others to do same, on your social media groups and pagea, in your local groups, and in larger ones.

In this podcast episode, we lay out the issue and WHY it’s such an issue. If you didn’t understand before, you will now!

This is not only about DIY looping… how do you like those watch faces you find so helpful? Sugarmate? Sugarpixel? Glowcose? And all the homemade versions of data displays that are used personally but are not on the market? Those would not have been possible without access to our own data.

Additionally, innovations in the DIY community are what have enabled the big companies to get their products to the point they’re at today, serving an enormous sector that doesn’t even realize it… and these innovations are constant.

It is important to act quickly, and it will only take a couple minutes.

If you want to see what some folks have shared: Regulations.gov

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Thank you for posting this here, too!

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The tiny url isn’t working for me. Can you please check it and edit if necessary? Thanks!

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This is the long link:

https://www.federalregister.gov/documents/2022/04/08/2022-07614/cybersecurity-in-medical-devices-quality-system-considerations-and-content-of-premarket-submissions?fbclid=IwAR08ZshnTEWOBRhgRKhQrs8HpVOUdMCwmwb6q4jppbByxkL1YWXvzuRH31M#open-comment

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I reran TinyURL and got the same one. They have changed things a few times but Robyn’s works too. Many thanks1

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The TinyURl still didn’t work for me but Robyn’s long link did.

It would be nuts if we don’t have access to all the data that can make our life easier!

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Thanks for posting this info, @Joanne11. Clean unambiguous access to your CGM data is important to everyone. I intend to submit my letter (comment on the FDA website) soon. There should be no confusion about who owns that data, first and foremost.

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Here’s the comment I made on the FDA website:

As an individual with type 1 diabetes (38 years) I depend on my real-time glucose data, every minute of every day. While it is measured and displayed by devices made by various companies, I consider that data, first and foremost, as my own.

I deliver insulin based on the minute to minute trends and I have had much success and good heath as a result of this method. I live with normal blood sugar and that means that my personal safety has benefitted too.

Any change to my real-time access to my glucose data will degrade my health and welfare. I hope that the decision-makers take this factor into consideration.

This data is uniquely mine and should be treated this way in every respect. For medical device manufactures to use cybersecurity as a pretense for preventing me from continued access for my devices is outrageous! Please ensure that my glucose data access through all of my devices does not end.

Thank-you.

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THANK you for posting this. The regulation is a bit convoluted, as such things often are. The following is what i posted to the site. I hope we will never lose access to our own data.

As a type 1 diabetic for the last 40 years, i have been both amazed and grateful for the science and technology that has given me tight control of a deadly disease. The scientists and corporations that have imagined, designed, manufactured, and provided live-saving devices, such as Continuous Glucose Monitors (CGM) and insulin pumps are appreciated by many in the diabetic community as heroes. None-the-less, any of the data produced by the technology is useless if it is not immediately, unambiguously, and continuously available to the patient. It has come to my attention that cybersecurity concerns regarding such data may change patient access to data. As a former programmer and network engineer, i understand those concerns. Thus, i am writing to your consideration.

*Like other diabetics, i rely on the real-time data from my devices to determine when to eat, what types of foods to eat, whether it is safe for me to exercise, whether it is safe for me to go to sleep, what over-the-counter medications i can safely consume, and how to manage all those variables with other autoimmune diseases or even with an ordinary cold virus. Most importantly, no matter how the data is displayed, no matter what corporation manufactures the device, the data is coming from my body, for my use, and belongs primarily to me, so that my health is effectively managed. *

*No two patients are alike in their medical conditions, and no scientist or corporation has the intelligence - artificial or otherwise - to manage so many health variables. But experienced diabetic patients, with the help of physicians, other medical professionals, and their greater diabetes community can - if we have immediate access to the unambiguous data our diabetes devices currently provide. *

The thought that any data provided by diabetes devices would be taken away, or in any manner delayed, is dangerous. The data belongs to the body that generated it, which is mine, and is used throughout every hour of every day by the patient, which is me. Please do not allow the developers or manufacturers of diabetes devices to take our data - or our improved lives - from us.

Respectfully,
…

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Well said!

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Heard the first 5 min. of the podcast but I got the gist. Posted my comment! Thanks for this.

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Can someone please post a link to the resolution or cut and paste the text of it? Thank you.

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