RECALL: Medtronic Infusion Sets
From Medtronic
Explanation of the Issue
Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue.
Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk.
To see if your infusion sets are part of the recall please go to this page supplied by Medtronic
https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice7-letter
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Further Press release
Nasal Glucagon Study in Phase 3
SAN DIEGO — Giving one puff of a dry glucagon powder inside the nose of an adult with type 1 diabetes who was having a moderate to severe hypoglycemic episode was easy for a caregiver to do and led to recovery within 30 minutes in almost all patients in a phase 3 study.
Specifically, the treated patients recovered from hypoglycemia within a half hour in 96% of cases, and 90% of the caregivers (typically a spouse) found the product easy to use, Elizabeth R Seaquist, MD, University of Minnesota School of Medicine, Minneapolis, reported at the recent American Diabetes Association (ADA) 2017 Scientific Sessions.
“It is premature to comment on when the product will be available in the US,” he cautioned, but if the NDA is approved, “we are excited to bring this product to market as quickly as possible.”
"We conclude that this 3-mg dose of nasal glucagon in a needle-free, user-friendly package provides a potential alternative to currently available injectable recombinant glucagon," she said.
"It really does look like [this investigational product] could be a good alternative to [intramuscular injectable] glucagon for treating severe hypoglycemia away from a hospital setting," she reiterated to Medscape Medical News.
Dexcom Announces FDA Approval of G5 Mobile App for Android Devices
SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (Nasdaq: DXCM) the leader in continuous glucose monitoring (CGM) for people with diabetes, is pleased to announce the Food and Drug Administration (FDA) approval of the Dexcom G5 mobile app for Android devices. Beginning in June, Android users will have access to the free app for the Dexcom G5 Mobile CGM System, allowing people with diabetes to view and monitor their glucose levels on their mobile devices to manage their diabetes in real time. The Dexcom G5 Mobile CGM System is the first and only CGM platform available for Android in the United States, complementing the 2015 iOS launch.
Download for free at the Google Play store here: bit.ly/AndroidDexcomG5MobileApp
The Dexcom G5 Mobile is a compact CGM system that works to display real-time glucose activity on certain approved display devices. The launch of Dexcom G5 Mobile for Android allows people to manage their diabetes in a more personal and discrete way by providing glucose data on their Android mobile device, as well as the ability to share it safely and conveniently. This empowers them to make informed and timely decisions about their diabetes, resulting in better health outcomes.
"Providing Android users with access to the Dexcom G5 Mobile CGM System has been a priority for Dexcom," said Kevin Sayer, President and CEO, Dexcom. "The new Android app has been thoughtfully designed with customer needs and feedback in mind. It focuses on delivering technology that empowers users by putting critical glucose information on their phones and is compatible with the most popular Android devices currently in the market."
Once commercially available, the new app will make the Dexcom G5 Mobile available on millions of additional phones in the United States. The Dexcom G5 Mobile app for Android will initially be available on several Android devices from Samsung, Motorola and LG, as well as Android Wear watches.
A current list of compatible devices can be found at www.dexcom.com/compatibility.
Individuals with Disabilities Education Act (IDEA)
Today, I am begrudgingly breaking a long standing rule on this blog of not talking about politics...
Betsy DeVos
Yesterday a new Education Secretary, Betsy DeVos, was confirmed by the Senate. DeVos a wealthy Republican donor who never attended a public school, is not an educator and has spent most of her life promoting charter schools and vouchers is now in charge of almost 100,000 public schools.
Today the government website for the Individuals with Disabilities Education Act is not responding...
I'm going to go out on a limb and say if it looks like a duck and quacks like a duck, you better start calling your Senators and Congresspeople.
About IDEA from the ADA website
What is IDEA?
The Individuals with Disabilities Education Act (IDEA) is a federal law that requires states to provide a "free, appropriate public education" to children with disabilities so they can be educated to the greatest extent possible along with all other children. Qualifying children are entitled to special education and related services at no cost to their parents/guardians.
Who is covered?
To receive services under IDEA, a child with with a disability must show that he or she needs special education and related services in order to benefit from education. An evaluation of the child must show that, because of the child's disability, the child's educational performance is harmed. There are three situations in which a child with diabetes might be covered under IDEA:
1. The child has another disability which impacts his or her ability to learn, but diabetes itself does not cause an impact in learning. For example, a child with Down syndrome might have an impact in learning.
2. Both diabetes and another disability combined impact the child's ability to learn. For example, it might be determined that a child's ability to learn is impacted by both autism and diabetes.
3. The child's diabetes, by itself, causes an impact on learning. This is categorized as an "other health impairment" under the IDEA.
While it is most common for a child with diabetes to qualify for IDEA because of having another disability in addition to diabetes, it is also possible that diabetes itself can cause an impact in learning. For example, it is often difficult to learn when blood sugar levels are either too high or too low. If a child with diabetes is having difficulty managing his or her blood sugar level, this may hurt how well the child does in school. Academic progress might also suffer if a child with diabetes misses a significant amount of classroom instruction each day in order to attend to diabetes care tasks.
The Center for Parent Information and Resources describes "Other Health Impairments" like this.
“Other Health Impairment” is one of the 14 categories of disability listed in our nation’s special education law, the Individuals with Disabilities Education Act (IDEA). Under IDEA, a child who has an “other health impairment” is very likely to be eligible for special services to help the child address his or her educational, developmental, and functional needs resulting from the disability.
(i) Is due to chronic or acute health problems such as asthma, attention deficit disorder or attention deficit hyperactivity disorder, diabetes, epilepsy, a heart condition, hemophilia, lead poisoning, leukemia, nephritis, rheumatic fever, sickle cell anemia, and Tourette syndrome; and
You can read the rest on their website here.
update 9:54am - Dept of Ed says this is not purposeful.
President Obama's Piece for the New England Journal Of Medicine
This piece from President Obama was published in the New England Journal of Medicine on January 26, 2017. Next week on the Juicebox Podcast I'll be highlighting three people living with type 1 diabetes, they will each be sharing their experience with the Affordable Care Act. - Scott
Repealing the ACA without a Replacement — The Risks to American Health Care
Barack H. Obama, J.D.
N Engl J Med 2017; 376:297-299 January 26, 2017 DOI: 10.1056/NEJMp1616577
Health care policy often shifts when the country’s leadership changes. That was true when I took office, and it will likely be true with President-elect Donald Trump. I am proud that my administration’s work, through the Affordable Care Act (ACA) and other policies, helped millions more Americans know the security of health care in a system that is more effective and efficient. At the same time, there is more work to do to ensure that all Americans have access to high-quality, affordable health care. What the past 8 years have taught us is that health care reform requires an evidence-based, careful approach, driven by what is best for the American people. That is why Republicans’ plan to repeal the ACA with no plan to replace and improve it is so reckless. Rather than jeopardize financial security and access to care for tens of millions of Americans, policymakers should develop a plan to build on what works before they unravel what is in place.
Thanks to the ACA, a larger share of Americans have health insurance than ever before. Increased coverage is translating into improved access to medical care — as well as greater financial security and better health. Meanwhile, the vast majority of Americans still get their health care through sources that predate the law, such as a job or Medicare, and are benefiting from improved consumer protections, such as free preventive services.
We have also made progress in how we pay for health care, including rewarding providers who deliver high-quality care rather than just a high quantity of care. These and other reforms in the ACA have helped slow health care cost growth to a fraction of historical rates while improving quality for patients. This includes better-quality and lower-cost care for tens of millions of seniors, individuals with disabilities, and low-income families covered by Medicare, Medicaid, and the Children’s Health Insurance Program. And these benefits will grow in the years to come.
That being said, I am the first to say we can make improvements. Informed by the lessons we’ve learned during my presidency, I have put forward ideas in my budgets and a July 2016 article to address ongoing challenges — such as a lack of choice in some health insurance markets, premiums that remain unaffordable for some families, and high prescription-drug costs. For example, allowing Medicare to negotiate drug prices could both reduce seniors’ spending and give private payers greater leverage. And I have always welcomed others’ ideas that meet the test of making the health system better. But persistent partisan resistance to the ACA has made small as well as significant improvements extremely difficult.
Now, Republican congressional leaders say they will repeal the ACA early this year, with a promise to replace it in subsequent legislation — which, if patterned after House Speaker Paul Ryan’s ideas, would be partly paid for by capping Medicare and Medicaid spending. They have yet to introduce that “replacement bill,” hold a hearing on it, or produce a cost analysis — let alone engage in the more than a year of public debate that preceded passage of the ACA. Instead, they say that such a debate will occur after the ACA is repealed. They claim that a 2- or 3-year delay will be sufficient to develop, pass, and implement a replacement bill.
This approach of “repeal first and replace later” is, simply put, irresponsible — and could slowly bleed the health care system that all of us depend on. (And, though not my focus here, executive actions could have similar consequential negative effects on our health system.) If a repeal with a delay is enacted, the health care system will be standing on the edge of a cliff, resulting in uncertainty and, in some cases, harm beginning immediately. Insurance companies may not want to participate in the Health Insurance Marketplace in 2018 or may significantly increase prices to prepare for changes in the next year or two, partly to try to avoid the blame for any change that is unpopular. Physician practices may stop investing in new approaches to care coordination if Medicare’s Innovation Center is eliminated. Hospitals may have to cut back services and jobs in the short run in anticipation of the surge in uncompensated care that will result from rolling back the Medicaid expansion. Employers may have to reduce raises or delay hiring to plan for faster growth in health care costs without the current law’s cost-saving incentives. And people with preexisting conditions may fear losing lifesaving health care that may no longer be affordable or accessible.
Furthermore, there is no guarantee of getting a second vote to avoid such a cliff, especially on something as difficult as comprehensive health care reform. Put aside the scope of health care reform — the federal health care budget is 50% bigger than that of the Department of Defense. Put aside how it personally touches every single American — practically every week, I get letters from people passionately sharing how the ACA is working for them and about how we can make it better. “Repeal and replace” is a deceptively catchy phrase — the truth is that health care reform is complex, with many interlocking pieces, so that undoing some of it may undo all of it.
Take, for example, preexisting conditions. For the first time, because of the ACA, people with preexisting conditions cannot be denied coverage, denied benefits, or charged exorbitant rates. I take my successor at his word: he wants to maintain protections for the 133 million Americans with preexisting conditions. Yet Republicans in Congress want to repeal the individual-responsibility portion of the law. I was initially against this Republican idea, but we learned from Massachusetts that individual responsibility, alongside financial assistance, is the only proven way to provide affordable, private, individual insurance to every American. Maintaining protections for people with preexisting conditions without requiring individual responsibility would cost millions of Americans their coverage and cause dramatic premium increases for millions more. This is just one of the many complex trade-offs in health care reform.
Given that Republicans have yet to craft a replacement plan, and that unforeseen events might overtake their planned agenda, there might never be a second vote on a plan to replace the ACA if it is repealed. And if a second vote does not happen, tens of millions of Americans will be harmed. A recent Urban Institute analysis estimated that a likely repeal bill would not only reverse recent gains in insurance coverage, but leave us with more uninsured and uncompensated care than when we started.
Put simply, all our gains are at stake if Congress takes up repealing the health law without an alternative that covers more Americans, improves quality, and makes health care more affordable. That move takes away the opportunity to build on what works and fix what does not. It adds uncertainty to lives of patients, the work of their doctors, and the hospitals and health systems that care for them. And it jeopardizes the improvements in health care that millions of Americans now enjoy.
Congress can take a responsible, bipartisan approach to improving the health care system. This was how we overhauled Medicare’s flawed physician payment system less than 2 years ago. I will applaud legislation that improves Americans’ care, but Republicans should identify improvements and explain their plan from the start — they owe the American people nothing less.
Health care reform isn’t about a nameless, faceless “system.” It’s about the millions of lives at stake — from the cancer survivor who can now take a new job without fear of losing his insurance, to the young person who can stay on her parents’ insurance after college, to the countless Americans who now live healthier lives thanks to the law’s protections. Policymakers should therefore abide by the physician’s oath: “first, do no harm.”
The Massachusetts Medical Society copyright applies to the distinctive display of this New England Journal of Medicine article and not to the President’s work or words.
This article was published on January 6, 2017, at NEJM.org.
SOURCE INFORMATION
Mr. Obama is the former President of the United States.