Savvy Updates, 7/5/22: Call for Advocacy: FDA re CGM Access to Data & Cybersecurity, How Immune Cells Learn, POGO BG Meter, Sleep Quality & T1D

The ENTIRE Diabetes Community needs you to take action. The US FDA held a webinar on Cybersecurity in Medical Devices in June 2022, asking for feedback and comments, accepted through 7 July 2022.

Time is of the ESSENCE!

At issue: Unlimited, real-time, and continuous access to our own CGM BG data. There is a consideration that CGM companies will be blocking access to us as the end-users while selling our data, for a licensing fee to their “partners” … anyone they choose, such as pump companies, display app companies, and possibly even insurance “partners”. OUR DATA going to outsiders, for profits, while restricting our own access to manage our own diabetes.

Secondary issue: Limited access to our data severely impacts the DIY innovation community. Without this community of “good guy” hackers who create better solutions at low cost (on their own free time, as a result of their urgency for better tools), innovation will grind to a halt. Most of the newer commercial closed-loop systems (Medtronic, Tandem, and Omnipod) credit the DIY community for blazing the trail and pushing innovation into the mainstream.

If creativity and DIY stop, companies will feel no pressure to create new products for all of us living with T1D.

PLEASE, let your voices be heard. The deadline for submission is THIS WEEK, 7 July 2022. THIS AFFECTS all people with diabetes, either directly (NOW) or by lack of innovation in the future.

Instructions:

- Tap on link: tinyurl.com/ct6n22ft
- Fill in the comment box with your message
- Select Option: Device Industry C0012
- Enter your email
- Tell about yourself: choose 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”

TAKE ACTION: Tell the FDA that you want ACCESS to YOUR OWN DATA

Want to hear a PODCAST about this? Joanne Milo Wants Her Data

Boot camp for the immune system: How immune cells learn to discern friend from foe was written by Ekaterina Pesheva, Harvard Medical School, for MedicalExpress.com, 28 June 2022. THIS IS FASCINATING!

The human immune system is a nearly perfect defense mechanism. It protects the body from disease-causing bacteria, viruses, and other pathogens. It detects nascent tumors and eradicates them. It cleans up cellular debris at the site of injury or infection. To perform its myriad functions, the immune system must, above all, differentiate between self and non-self—a remarkable selective ability that allows it to detect and disable harmful agents while sparing the body’s own tissues. If the immune system fails to make this distinction, it can mistakenly launch an assault against the body, causing autoimmune disorders.

A new study led by researchers at Harvard Medical School identifies a new mechanism that explains how the body’s most powerful immune troops—T cells—learn to tell self and non-self apart. The work, conducted mainly in mice, was published online June 16 in Cell and is scheduled to appear in the July 7 print issue.

The research shows that the thymus gland—the organ where T cells are born and trained—educates nascent immune cells by exposing them to proteins made by thymus cells that mimic various tissues throughout the body. Specifically, the research demonstrates that by assuming different identities, these specialized thymus cells preview for the maturing T cells self-proteins they would encounter once they leave their native thymus gland.

“Think of it as having your body recreated in the thymus,” said study senior author Diane Mathis, professor of immunology at Harvard Medical School. “For me, it was a revelation to be able to see with my own eyes muscle-like cells in the thymus or several very different types of intestinal cells.” The findings, Mathis said, shed light on how the adaptive immune system acquires its ability to discern friend from foe. Glitches in this critical recognition system can have grave consequences.

“Our immune system is super powerful. It can kill any cell in our body, it can control any pathogen we encounter, but with that power comes great responsibility,” said study first author Daniel Michelson, an MD/Ph.D. student at Harvard Medical School and a researcher in the Mathis/Benoist lab. “If that power is left unchecked, it can be lethal. In some autoimmune diseases, it is lethal.”

POGO Automatic is the first FDA-cleared glucose monitor and multi-test cartridge system for diabetes management.

Medical technology company Intuity Medical secured FDA clearance for its POGO automatic blood glucose monitoring system. In 2016. The POGO system is claimed to be the first blood glucose meter and multi-test cartridge to offer automatic testing with lancing, blood collection, and analysis in one easy step.

To perform the test using the POGO blood monitoring system, a patient presses the POGO test port, and POGO automatically lances the finger to collect a blood sample and displays a result after a four-second countdown.

The meter only requires a tiny blood sample of 0.25 microlitres to assess the glucose value. You’ll never handle another lancet or strip again. They’re ready to use, inside this completely integrated monitor.

The FDA requires blood glucose meters to have an accuracy of ±15% compared to a reference method like the one a hospital uses. The FDA reviewed POGO Automatic and agreed that it meets ±15% accuracy. (9 March 2022)

I’m ordering one to test it. If I like it, I’ll ask the company to share a discount code for The Savvy Diabetic readers.

Read more: Pogo Automatic

Poor sleep quality linked to higher type 1 diabetes distress in young adults was reported by Michael Monostra for Healio.com/endocrinology, 24 June 2022.

Young adults with type 1 diabetes have more diabetes distress symptoms with shorter sleep time, lower sleep efficiency, and higher sleep variability, according to a study published in The Science of Diabetes Self-Management and Care.

“When an individual has inadequate sleep quantity or quality, a functional deficit occurs between the amygdala and ventral anterior cingulate cortex, resulting in decreased mood, a heightened response to negative stimuli, and altered inhibitory function,” Stephanie Griggs, PhD, RN, assistant professor at the Frances Payne Bolton School of Nursing and faculty associate at the Schubert Center for Child Studies at Case Western Reserve University, told Healio. “Sleep extension has restorative benefits, normalizes inhibitory function and suppresses amygdala hyperactivity, thereby resulting in fewer or no emotional or physical symptoms.”