In the News.. Medtronic safety alert, Omnipod 5 in Europe, T1D Index launched and more!

It’s In the News! This week’s top diabetes headlines and stories include: cybersecurity risk cited for some Medtronic pumps, Omnipod 5 gets European approval, new data about the Freestyle Libre and avoiding hospitalizations, the new T1D Index and more!

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population.
https://t1dexchange.org/stacey/
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potential cybersecurity risk for Medtronic MiniMed 600 Series Insulin Pump Systems. The FDA sent out an alert for multiple systems including the MiniMed 630 G and MiniMed 670G. They say this is a potential issue and that there have NOT been any reports of actually unauthorized access. Medtronic has issued an Urgent Medical Device Correction on their own website notifying users as well as providing recommended actions.
If unauthorized access occurs, the pump’s communication protocol could be compromised, which may cause the pump to deliver too much or too little insulin,” noted the FDA’s September 20 Cybersecurity alert.

On their website, Medtronic provides the Urgent Medical Device Correction, a list of model numbers impacted by the issue, and a multitude of frequently asked questions for device users. Within these resources, Medtronic notes the issue was identified through an internal review and, while the event meets the definition of a recall, users are not required to return their devices.

In a letter to users, which was signed by Chirag Tilara, vice president of Quality at Medtronic Diabetes, and Robert Vigersky, MD, chief medical officer at Medtronic Diabetes, the pair recommended all patients turn off the “Remote Bolus” feature on their pump if it is turned on, which is on by default. The letter also urged users to conduct any connection linking of devices in a nonpublic setting. Additional recommended precautions from Medtronic included keeping pump and connected system components within user control at all times, be attentive to pump notifications, alarms, and alerts, and immediately cancel any boluses you or your care partner did not initiate.

The FDA urged those with questions to reach out to Medtronic at 1-800-646-4633, option 1.
https://www.endocrinologynetwork.com/view/cybersecurity-risk-minimed-600-systems-alert-from-fda-medtronic
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Omnipod 5 gets the CE Mark, that’s European approval for individuals aged two years and older with type 1 diabetes. This comes as Insulet presents new studies at the European Association for the Study of Diabetes (EASD) meeting in Stockholm, Sweden.
https://www.businesswire.com/news/home/20220920005138/en/Insulet-Announces-CE-Mark-Approval-for-Omnipod%C2%AE-5-Automated-Insulin-Delivery-System

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Abbott says the Freestyle Libre system can help reduce diabetes-related hospitalizations. Data from the Real-World Evidence of Freestyle Libre (RELIEF) were presented this week. The retrospective study of the French national health claims database shows that the 5,933 people with Type 2 diabetes who were following a basal-only regimen and using the FreeStyle Libre system had 67% fewer ADE-related hospitalizations one year after initiating the FreeStyle Libre treatment.
The data also show a 75% reduction in hospitalizations for diabetic ketoacidosis (DKA), a potentially life-threatening condition when glucose levels are too high for too long and ketone levels rise to dangerous levels in the blood, and a 44% reduction in admissions for severe hypoglycemia (low glucose levels).

Further, the study showed sustained reductions in hospitalizations over a two-year period of FreeStyle Libre system use, regardless of whether the patients were under the care of a diabetes specialist or a general healthcare practitioner.
https://www.mddionline.com/diabetes/can-abbotts-freestyle-libre-help-reduce-diabetes-related-hospitalizations
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A look at bone health and type 1 diabetes in teen girls. Small study herewith girls age 10-16.. found that the more sedentary had worse markers of bone health in imaging tests than girls without diabetes. When the groups had the same physical activity, no difference was seen regardless of diabetes. However, this is early research and further study is needed, the group cautions.

However, if further, rigorous studies confirm these findings, "physical activity is potentially a really effective means of improving bone quality in kids with type 1 diabetes."
https://www.medscape.com/viewarticle/981092
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Back to the news in a moment but first..
The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.
The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey
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DRF, a global type 1 diabetes (T1D) research and advocacy organization, announces the launch of the Type 1 Diabetes Index (T1D Index). The T1D Index is a first-of-its-kind data simulation tool that measures the human and public health impact of the T1D crisis in every country across the globe. Until now, there have been wide gaps in the data about the incidence and impact of T1D. Leveraging data and insights from the T1D Index can help change the lives of people living with T1D by identifying attainable country-by-country interventions including timely diagnosis, accessible care and funding research that could lead to cures.
The T1D Index and accompanying research has been published in The Lancet Diabetes & Endocrinology.

T1D is an autoimmune condition and one of the fastest-growing chronic health conditions, impacting nearly nine million people across the globe. Certain factors like family history can increase risk, but it is not caused by diet or lifestyle. T1D causes the pancreas to make very little insulin or none at all—this means the human body cannot convert food into energy, which can lead to long-term complications including damage to the kidneys, eyes, nerves, heart and even premature death. There is currently no cure for T1D.

"As a member of the T1D community, I know many are not as fortunate as I am to have the resources necessary to live a healthy and fulfilled life," Aaron Kowalski, Ph.D., JDRF CEO, said. "This is why I am so proud that significant progress has been made to understand T1D's global impact through the T1D Index. We are calling on government and public health decision makers throughout the world to utilize the tool to identify and implement interventions that can change the trajectory of T1D."

JDRF collaborated with key partners and experts around the world to develop the T1D Index—using the results from a global survey of more than 500 endocrinologists and 400 publications to simulate the state of T1D globally and at the country level.

The Index uniquely illuminates the human burden of T1D by highlighting "missing people," which is the number of people who would still be alive today if they had not died early due to complications from T1D, and "healthy years lost," which represents time lost to ill-health, disability or early death from living with T1D.

Simulations from the T1D Index suggest that globally, as of 2022, there are more than 3.86 million "missing people" and an average of 32 "healthy years lost" to T1D per person, if diagnosed at age 10.

T1D presents a profound human, emotional and financial burden for those who live with it—and prevalence is on the rise. Simulations from the T1D Index have led to the identification of four key interventions that could change the current trajectory for T1D and its impact on people around the world:

Timely diagnosis: enabling better education and training for medical professionals to accurately diagnose T1D. If the global population has access to timely diagnosis from 2023, 668,000 more people could be alive in 2040.
Insulin and strips: creating barrier-free access to insulin and blood glucose testing strips. If the global population has access to insulin and testing strips from 2023, and coaching to self-manage the condition, 1.98 million more people could be alive in 2040.
Pumps and CGMs: ensuring everyone living with T1D has access to technology that automates glucose monitoring and insulin delivery. 673,000 more people could be alive in 2040 if everyone with T1D has access to the technology available from 2023.
Prevention and cures: making the case for further investment and research in emerging prevention, treatments and cures. 890,000 more people could be alive in 2040 if we find cures.
Once interventions are identified on the global and country level, the T1D Index encourages users to take action by sharing the data and findings with their networks and local decision makers, and connecting with other T1D advocates in their communities.

Additionally, the T1D Index shines a light on important statistics about the burden of T1D globally, including:

Since 2000, T1D prevalence has increased at four times the rate of global population growth.
The expected number of people living with T1D in 2040 will be 17.43 million.
The number of "missing people" in the year 2040 is projected to be 6.85 million.
https://medicalxpress.com/news/2022-09-global-diabetes-index.htmlXX
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