Kelly's Bionic Pancreas Trial
Episode 42 of my podcast is an hour long conversation with an RN and CDE who recently completed a six week bionic pancreas study at Massachusetts General Hospital.
I'm going to drag you blog readers into the podcast world one way or another, might as well come peacefully... :)
You can listen right hear in the blog post with this player or through iTunes. An hour may seem like a lot of time but you can listen while you do the laundry, do the dishes, grocery shop or while your are in the car.
More photos from Kelly's bionic pancreas trial are available here.
Next weeks episode is an hour with actor Victor Garber. Victor has been living with type 1 diabetes since he was 13 years old and he is about the most delightful person I've ever met. Subscribe today.
Glucagon Nasal Spray Effective for Hypoglycemia Rescue
Spray device easier for untrained people to use, experts say...
- Intranasal glucagon is effective and noninferior to injectable intramuscular glucagon for the correction of insulin-induced hypoglycemia in adults with type 1 diabetes, according to a randomized, cross-over study.
- Note that hypoglycemia was induced by administering insulin in a controlled setting, but this approximates the real-world setting of severe hypoglycemia occurring due to excessive therapeutic insulin with inadequate or absent endogenous glucagon response.
- An intranasal glucagon spray was as good as injectable glucagon for treating induced hypoglycemia in patients with type 1 diabetes, according to a randomized crossover noninferiority study.
- The effect of the nasal spray lagged a few minutes behind that of injections, but it met the study's pre-defined success criteria 74 out of 75 times, compared to 75 out of 75 with injectable glucagon, reported a team of investigators led by Michael Rickels, MD, of the University of Pennsylvania in Philadelphia.
- Currently, only injectable glucagon is available for treating hypoglycemic episodes, and it comes in a powder that must be reconstituted in a diluent before injection.
- The intranasal glucagon, developed by Locemia Solutions, is in phase III clinical testing. Eli Lilly recently announced that it acquired worldwide rights to Locemia's intranasal glucagon and plans to bring it to market.
Check out an episode of the Juicebox Podcast today...
Judge: Medicare Must Cover CGM for T1D Patient
This article will be referenced in episode 39 of the Juicebox Podcast (to post at midnight 11/23/15). A conversation with Insulet's CCO Shacey Petrovich.
reposted from Medpage Today
by Parker Brown
Staff Writer, MedPage Today
A Medicare provider must cover a continuous blood glucose monitor (CGM) for one of its patients with type 1 diabetes, an administrative law judge has ruled.
The patient, Jill Whitcomb, had recently become eligible for Medicare, which does not cover continuous glucose monitoring devices, provided through United Healthcare of Wisconsin/Secure Horizons. Whitcomb has had type 1 diabetes for more than 35 years, with diabetic neuropathy and a history of hypoglycemia unawareness. A video of Whitcomb having a severe episode of hypoglycemia when she was not using a CGM because she lacked a Certificate of Medical Necessity from the doctor was used as evidence in a trial earlier this year.
United has not yet offered to cover the device and has until Dec. 14 to appeal the decision, said Dan Kraft, Whitcomb's caretaker.
Courts may be forcing CMS' hand for coverage of continuous glucose monitors
George Grunberger, MD, president of the American Academy of Clinical Endocrinologists (AACE), said in an interview with MedPage Today that he has been following this case with interest for several years. The AACE has tried to convince the Centers for Medicare & Medicaid Services to cover CGM for patients with type 1 diabetes who age into Medicare coverage, he added.
"All of our meetings, petitions, and lobbying have met with rejections thus far in spite of uniform recommendations of all relevant professional societies," Grunberger said. "This ruling will hopefully re-energize the efforts to bring 21st century thinking into Medicare decisions. It's all about safety, not just better care for our insulin-requiring patients."
Since the ruling last month, other administrative law judges have cited Whitcomb's case and have ordered that CGMs be covered for the plaintiffs, Kraft said. He provided a document of a recent ruling in which the judge found that the Whitcomb decision was "well reasoned and on point" and that "coverage of a continuous glucose monitor should turn on whether or not the item is medically reasonable and necessary for the beneficiary."
The costs of the monitors and supplies can be substantial: the device alone can cost $400 to $2,000, and the associated consumables can add up to $300 a month. But Medicare considers the device to be "precautionary" and therefore not eligible for coverage.
The court disagreed, ruling that the CGM falls under what Medicare calls a Durable Medical Equipment statutory benefit and is eligible for coverage. The judge also concluded that the device is "medically reasonable and necessary" for Whitcomb, citing evidence by the American Diabetes Association that CGM, "in conjunction with intensive insulin regimen, is a useful tool to lower A1C in adults with type 1 diabetes mellitus, and for those with hypoglycemia unawareness and/or frequent hypoglycemic episodes."
The judge wrote in the final decision that it was clear that Whitcomb was a "brittle diabetic" and that the device is medically reasonable and necessary in her case.
Appealing Medicare decisions is a five-step process. In 2013, an administrative law judge concluded that United must cover the device for Whitcomb, but United filed a request for a review by the Medicare Appeals Council -- the fourth step. That council reversed the decision, according to court documents, and Whitcomb and her attorney filed a complaint in U.S. District Court in November of that year.
But in May 2015, the district court remanded the case to the Secretary of Health and Human Services, saying that the secretary had erred in one of her conclusions. The Medicare Appeals Council vacated its earlier decision and the case was sent to the Office of Medicare Hearings and Appeals, where the latest decision was issued and United was ordered to process Whitcomb's claim.
"As far as moving forward, it will take patients themselves, individually and through patient advocacy groups, to pressure their legislators to change the Medicare coverage language to recognize the tangible benefits this technology represents to their constituents' lives," Grunberger said. "The professional societies have done their part in incorporating the technology into their position statements and guidelines."
Terrorism Meets World Diabetes Day
Yesterday the unthinkable happened. Terrorism was thrust upon Paris France and in an instant hundreds of people were dead or injured in a senseless attack. It is an event that thankfully most of us will never be able to fully grasp but that fact won’t and should’t stop us from trying.
My family was having dinner in a restaurant as the attacks were happening. This restaurant has televisions hanging everywhere, each showing a different sporting event. I asked our waitress if they ever tune one of the televisions to the news and she replied, "sorry, just sports" and then she asked me why I wanted the channel changed. She had no idea, having been at work since the late morning, what was happening in the Paris. When we explained about the terrorist attacks and that they were at this very moment still happening, she appeared unfazed. I was saddened by her response but I understood that she has grown up in a world where this sort of violence is frequent and customary. We continued to get our news through social media and watched the situation worsen by the moment. I began to look around the room and wonder what happening to the world that I grew up in, the world that would stop in moments like this one and reflect - not just until the next story came along but for days and weeks. I don’t believe that humanity should cease to exist every time crazy people infect the world with their insanity, we all need to continue to live our lives. Still, the two thoughts conflict for me and I felt reminiscent for a time where I would have looked up and witnessed a community response to the events happening in the world.
Late last night I cancelled the World Diabetes Day post that was scheduled to run on Arden’s Day today because it contained the words "celebrate" and "happy”. I did so with a measure of sadness as I thought about how much effort the diabetes community puts into raising awareness for type 1 and type 2 diabetes each year. “I can't believe these two days are intersecting", I thought as I placed my head on the pillow only mostly comfortable with my decision to wait until next week to run the content.
Today I woke and witnessed a disagreement online that I must admit that I could never see coming. Passionate supportive people who both completely agree with one another were fighting about how they choose to recognize today and their anger and vitriol was escalating. Their words are what led me to write this piece and to recolor the Jean Jullien art in World Diabetes Day blue.
I witnessed people online devastated by terrorism this morning and as in most situations where you are ultimately powerless but determined to make a difference, we do what we can to show our support. Many people applied overlays to their social media avatars using the colors of the French flag. Not just beautiful to see as your timeline streams but spiritually helpful as you struggle to make sense of what happened yesterday. This is a simple act in social media that we can all agree is called for on a day like today. A small yet powerful message that says that while I may be unable to act personally, I feel on a global level as a human being. This act when aggregated truly makes a difference. A small gesture that joins with other small gestures to create a huge and meaningful statement. Somewhat ironically, this is exactly the impact that we hope our diabetes advocacy will bring.
Je suis Paris
Then I saw the people who live each day with type 1 and type 2 diabetes, people who have put all that they are into preparing for World Diabetes Day. These people are also deeply touched by Paris yet can't shake the feeling that today was their chance to say to the world, “please take a moment to understand what life with diabetes brings to the people who are affected”. It was our day to beg the world…
- Please stop using diabetes as the punchline for your jokes.
- Please understand that insulin keeps me alive while simultaneously trying to kill me.
- Please hear how sad, drained and beaten I am even though I won’t show you.
- Please FDA, stop thinking of continuous glucose monitors as a luxury.
- Please insurance, cover my drugs and supplies.
- Please someone take this day and focus for a moment on the world wide tragedy that my family happens to be trapped in, through no fault of their own.
Therein lies the the problem today. Diabetes is a world wide tragedy but you just can’t say those words in the face of another world wide tragedy like the one that occurred in Paris yesterday. You just can’t and you probably should’t. Yet I wonder in the same breath how do we shut down the desire to take the opportunity? How can we sit on our hands when this was to be the day people were going to be open to listening, to acting? How do you do that when you need a cure so badly that you want to cry almost all of the time? How do you do that when it is your child, mother, husband and friend that you are banging this drum for? How did terrorism effect diabetes advocacy and cause great people all who live with this chronic illness to turn on one another on the very day that was set aside for them to unite. All we wanted to do today was speak, to reach others and say please see diabetes for what it is and help if you can. Understand if you can’t help. Advocate for me and please spread this message beyond those who already understand it far too well. Today feels like the day that it is possible to reach a person who would make a diabetes joke offhandedly and help them to understand just how egregiously they misunderstand a life with diabetes.
You may believe that it is in bad taste to say Happy World Diabetes Day to someone today, you may not. You may wish that your friend’s avatars were blue yet understand that they are adorned in the colors of the French flag. Perhaps you are feeling like your opportunity has been stolen and at the same time know that it is inappropriate to make that statement when people’s lives have been stolen. What all of of this means is that two unthinkable tragedies have met and the honest truth is that they are both terrible. Trying to judge one against the other is a futile act. You can try to make an argument for one side or the other but really, what would that accomplish besides diminishing something that you don’t want to diminish. The only real answer today is to live and let live, which if you think about is a thought that would have saved not just the people of France but everyone who has ever been touched by violence. The best thing to do today is act as you wish the world would, with peace, understanding and humanity for all. Live and let live because judgement always leads to a ruling and we don’t need to be ruled - not on this day or any other.
Scott
Darth Vader has Type 2 Diabetes
Did you know that James Earl Jones has type 2 diabetes?
So many people live each day with diabetes. Regular folks like Arden, actors, athletes and even Sith Lords bent on destroying the universe or at least the actors who give them their voices.
You know what the worst disease in the world is - the one you have...
Type 1s and type 2s may face different day-to-day challenges but they are eternally united in many other ways. Please use diabetes awareness month to remind yourself that no matter what "type" you are, we are all fighting the same evil empire. Advocate for all becasue no one person's struggle is any worse or more difficult than another's. The worst disease in the world is the one that you or a loved one has - it's not a competition.
So don't take your tolerance cues from Darth Vader... be a Jedi - a diabetes advocating Jedi!
How about a little non-diabetes related bonus content today? Please enjoy the all new Star Wars posters that we're released yesterday. Perhaps they would make a great background for your child's phone (or maybe the little kid in you would like one on yours). May the force and the support of every person living with diabetes, be with you!
Thyroid Disease & Type 1 Diabetes. Undiagnosed hypothyroidism in people with type 1 diabetes can quietly wreak havoc — slowing growth, dropping blood sugars, and draining energy.
💊 Levothyroxine tips
💡 When “normal labs” aren’t enough
🧬 Why type 1 and Hashimoto’s often come as a pair