New OmniPod Pictures and Information

It's official! The next generation of the OmniPod Insulin Management System has been approved by the FDA!

I've just finished speaking with Sean Gallagher, Senior Director, Marketing for Insulet, person living with type I diabetes and OmniPod user. We spoke for a bit this afternoon and I have some fresh information about the new Pods and PDM to share.

The name remains the same: You won't be wearing the OmniPod G2 or OmniPod Lite. Just good old OmniPod.

Pricing: There will be no price increase for the new system.

Transition: Insulet has been working for "18 months" to make the transition to the new smaller pod "easy" and fast for us the users.

How the upgrade happens: Current OmniPod users will receive an email stating that upgrading is possible. All you have to do is contact them back to get the ball rolling. Sean stresses that the process will be super easy, fast and efficient. They are working hard to make the transition a pleasure.

When? When can I get them?: There is some training of staff, endos and the like that's happening now. Expectations are that those steps will be finished and the new Pods will begin being delivered in the first quarter of 2013. I know you feel like you've heard that before but this time the ball is completely in Insulet's court, they have control, I'd bet anything that this time frame is accurate.

More when: For customers that are currently under warrantee. Your new Pods will arrive after you've exhausted the stock that you have in your home. Upgrades will happen at re-order only.

Any insurance stuff to worry about?: Simply, no. If you happen to be outside of your warrantee there will be some steps to take between Insult and your insurance company but Sean assures me that most of that process will happen on their side of the equation, requiring only a minor amount of effort on your part. The man said, "easy" is their goal, I believe him.

Interesting technical stuff

• The insulin reservoir capacity remains the same even though the pod is smaller.


• I asked Sean, "how did your R&D people accomplish the size reduction?" He responded simply by saying, "they're brilliant!". The slightly more technical reasons however include, the insulin reservoir shape has been changed to an oval and flattened. Plus the new Pods require only three, instead of four batteries because of enhancements that lessened power requirements.


• The new PDM has a dramatically improved stated signal range of five feet, but between you and me, I've seen and used one during FDA required Human Factor Testing... I'd try backing up if I was you.


• The smaller Pods have a new feature called a 'pink slide.' When the cannula deploys correctly, it pushes a piece of pink plastic to be visible through a new, second window on the top of the pod's surface. You can use this together with the regular viewing window for additional confirmation of insertion. - Info and picture added at 5 pm on 12/14 after second conversation with Insulet.

Why the long wait:

I expressed to Sean that the long wait for the newer, smaller, lighter OmniPod made me wonder if they were ever going to see the light of day in the U.S.

Sean indicated that the Human Factor Testing requirement from the FDA was in it's infancy (my word) when they were seeking approval and that both sides lived through a learning curve. He did stress that he genuinly belives that the "process is valuable" and when I asked if it was fair to say that the process provided me (and you) with a better, safer insulin pump, he did not hesitate to say, "yes".

Sean closed out our discussion with two thoughts that I will share.

He hopes, for two reasons, that those of you that may be preparing to begin pumping with OmniPod don't feel as though you should wait for the new Pods to become available. His first point (that I can completely agree with) was simple. The current version is a great device. I can't argue with that. If you start today you will be using a wonderful insulin pump, one that has benefited many including Arden for years. His second point was a reminder that the transition to the new Pods will be so easy that it won't even cause a blip in your day to day life. So there's no reason to wait.

I'm choosing to include his thoughts, that you may read as marketing (and perhaps it is) not just because I believe in the company, but also because I know that Insulet is a small company. I don't know for sure, but I'm willing to guess that they wouldn't do well financially with a less then normal amount of new customers over the next three or so months. That's my honest take on this issue, I make no secret that I'd like Insulet and OmniPod to thrive, it's good for my daughter and for all of you that wear the pump.

Lastly:

Sean wanted all of us to know that he and Insulet appreciate all of our paitence during this long journey. He is thrilled by the reception that OmniPod receives in our community and is touched by the eagerness that the new generation OmniPod is being greeted with. He said, "I am happy and excited to put the new OmniPod into hands".

Now for the pictures, you know you want to see the pictures!

Hi-Res version are available in the Visual Record section of the blog.

Update on Monday, December 17, 2012 at 12:46PM by Scott Benner

I have good news about the new OmniPod for my Canadian friends right here

Pathway to Stop Diabetes

Image courtesy of Pathways to Stop Diabetes

The American Diabetes Association has just announced an initiative called Pathways to Stop Diabetes. Here is a brief snippet from their website about the program's intentions.

We realize that it takes more than natural talent for young researchers to realize their full potential. It takes comprehensive support every step of the way. To make the career commitment to diabetes research attractive, fulfilling and rewarding, Pathway to Stop Diabetes will provide that support in every way.

I think that it's very exciting to see such a large organization thinking about research in a different way. It's also encouraging to see that program financially backed so significantly by pharma companies. I hope you can take a few minutes to learn more about Pathway.

If you are a brilliant young scientist, are raising one or know a young researcher that may be interested in being at the forefront of discovery. Please consider diabetes research as your field of focus. Pathway offers researchers mentoring, grants and much more. Who knows, maybe you're the next Frederick Banting, MD. 

More blurbs from the Pathway to Stop Diabetes website:

"Our vision is simple yet revolutionary: find a new generation of brilliant scientists at the peak of their creativity, then provide them with the freedom, autonomy, and financial and professional resources to set them on the road to breakthrough discoveries."

"Diabetes research is critically underfunded. Twice as many Americans have diabetes as have cancer. Diabetes is over 20 times more prevalent than HIV/AIDS. Yet National Institutes of Health (NIH) funding for diabetes is 1/5 that of cancer and 1/3 that of AIDS. On a per-person-affected basis, diabetes funding is a rounding error in comparison. This difference has persisted for decades." - more

Arden's Day wishes the Pathway program a very successful (but hopefully short) life!

Be well,

Scott

What are your thoughts on this diabetes news article?

My wife showed me this article from NBC news and it made me wonder how everyone felt about the manner in which type I diabetes is dealt with in the media. I hope you leave your thoughts on the writing, topic, how it makes you feel or anything else that strikes you about the article. I'm very interested in your take! - Scott

Surprising number of deaths linked to undiagnosed diabetes

By Linda Thrasybule
MyHealthNewsDaily

People who don't know they have Type 1 diabetes may account for a surprising number of deaths from one complication of the condition, a new study says.

Nearly a third of people in Maryland who died over a six-year period from diabetic ketoacidosis, a condition of severe insulin deficiency, had no known history of diabetes, the study of autopsy results found.

While the researchers weren't able to definitively tell whether those who died had Type 1 or Type 2 diabetes, their high blood sugar levels suggest they probably had Type 1, said study researcher Dr. Zabiullah Ali, the assistant medical examiner for the Office of Chief Medical Examiner in Maryland.

The finding highlights the need for regular physicals that include checking blood sugar levels, especially if warning signs of diabetes are present, the researchers said.

The study was published in the September issue of the American Journal of Forensic Medicine and Pathology.

What happens when the body runs out of sugar

Diabetic ketoacidosis is a complication of diabetes that occurs when body cells don't have enough glucose (sugar) to use for energy, so they switch to burning fat instead. (Body cells need insulin in order to take up sugar from the bloodstream; in people with Type 1 diabetes, little or no insulin is produced.)

High 'normal' blood sugar may still harm your brain

Breaking down fat for energy produces molecules called ketones, which are acids and can build up in the blood. If ketone levels climb too high, they can poison the body, causing chemical imbalances that can lead to coma, or death.

In the study, Ali and colleagues looked at 20,406 autopsies and found 107 people who had died from diabetic ketoacidosis, although only 92 had data available for further review.

Out of the 92 cases, they found that 60 people were previously diagnosed with diabetes, while 32 were not.

Nearly half of those who died with no history of diabetes were in their 40s. The researchers also found that 84 percent of these cases were men, and 53 percent were African-American.

Adults can be diagnosed with Type 1 diabetes too

Type 1 diabetes was long referred to as "juvenile diabetes," because people tend to be diagnosed with the condition during childhood.

But now, "physicians are becoming more aware of the possibility of a diagnosis of Type 1 diabetes in the adult population," said Dr. Mark S. Segal, a nephrologist at the University of Florida, who was not involved in the study.

"It's relatively new that we're seeing more adults are being diagnosed with Type 1," Segal said.

Ali emphasized that people should pay attention to any warning signs that point to diabetes, such as needing to urinate frequently, constant thirst, nausea and vomiting.

Type 2 diabetes linked to common virus

People newly diagnosed with Type 1 diabetes may go through a "honeymoon period," in which they may be able to function even though they aren't making insulin — but that period doesn't last long, he said.

"Once the period ends, they get into trouble fast," Ali said. Healthy people should have their blood sugar checked one or twice a year.

"But if you have symptoms, you should go to the doctor immediately," he said.

News: MIT researchers develop a way to inject drugs at near speed of sound without needles

From TheVerge.com

MIT scientists are developing a needle-less injection technology that could see doctors administering drugs using a tiny high-pressured jet in future. Researchers unveiled a device this week that eliminates the use of needles by delivering drugs into tissue using a high-pressured stream right into the skin.

The technology will benefit those who are afraid of needles or who have to frequently self-inject says Catherine Hogan, a research scientist at MIT. "We think this kind of technology … gets around some of the phobias that people may have about needles." Drugs can be fired out at almost the speed of sound at around 340 meters per second, with a wide variety of volumes and velocities supported. MIT's jet technology is of a similar diameter to a mosquito proboscis, which many humans do not feel entering their skin, so the injections will be painless.

Ways to create painless needles have been explored before by other scientists using patches or reshaping the traditional needle, but MIT feels its latest technology allows it to breach the skin at different velocities and with varying amounts of doses in a highly controlled way. MIT is also working on a similar version of the device to turn powdered form drugs into a "fluidized" form to be delivered into the skin like a liquid.

Alzheimer's and insulin resistance

This is an old article from Time Health but it raises interesting points about insulin's effect on Alzheimer's and I thought it was worth sharing.

When the body refuses to make insulin, the condition is called type 1 diabetes; when the body mismanages the hormone, it's known as type 2. Now, scientists report new evidence linking insulin to a disorder of the brain: when the brain prevents the hormone from acting properly, the ensuing chemical imbalance may help trigger Alzheimer's disease. The correlation is so strong that some researchers are calling Alzheimer's disease "type 3" diabetes.

In the body, insulin helps convert food into cellular energy. But the brain has other uses for insulin, namely as a means to learn and make new memories. Here's how it works: At synapses, the spaces across which brain cells communicate and where memories are conceived, neurons reserve special parking spots just for insulin. When the hormone pulls in, a connection is made that enables new memories to form. Since new memory formation is one of the first things to go awry in people with early stages of the disease, this insulin-initiated process may hold the key to decoding the mystery of Alzheimer's.

In August, a team of scientists at Northwestern University were the first to show why the brain's "memory function" fails in the face of an insulin shortage. The group's prior research had already pinpointed the culprit: toxic proteins called amyloid beta-derived diffusible ligands (ADDLs, for short), which are known to pile up in the brains of people with Alzheimer's. Scientists also knew that Alzheimer's patients' brains have lower levels of insulin and are insulin resistant. But what the Northwestern team discovered is the molecular mechanism behind that resistance: when ADDLs bind to neurons at synapses, they obliterate the receptors that are normally reserved for insulin. Without those parking spaces on the brain cells' surface, insulin has no place to connect, and memory fails.

"We now understand that the function of insulin at those synapses is to modulate and influence the underlying cellular structure of memories," says William Klein, professor of neurobiology and physiology at Northwestern University and a co-author of the study published online by the FASEB Journal. "What we have here is a striking phenomenon that may ultimately explain why the brains of people with Alzheimer's disease are insulin resistant and how that ties into memory."

Researchers hope these findings will help shape future research in Alzheimer's therapy — perhaps in the development of drugs that can make brain cells' insulin receptors more responsive to the hormone, or in the application of type 2 diabetes drugs, which address insulin resistance, to Alzheimer's.

The notion that Alzheimer's disease might be a neuroendocrine disorder, akin to diabetes, isn't entirely new; it first showed up in the scientific literature roughly 20 years ago, but the idea petered out. In 2005, Suzanne la Monte, a neuropathologist at Brown University Medical School, revisited the idea. Based on two of her discoveries — that the brain makes its own insulin and that Alzheimer's disease depletes insulin — she coined the disease process "type 3" diabetes.

Still, referring to Alzheimer's disease as "type 3" diabetes is controversial, especially within the diabetes community. Alzheimer's disease is a complication of diabetes, not a unique form of the disease, says Dr. Sue Kirkman, vice president of clinical affairs for the American Diabetes Association. "Nevertheless," she says, "this is primarily a semantic argument."

The terminology aside, both diseases share many traits and risk factors, including high cholesterol, high blood pressure, and metabolic disorders. So, de la Monte sees the semantic "splitting of hairs" as a good thing. "People are arguing about small parts of the bigger story," she says. "At the end of the day, these conversations will help us to better understand both diabetes and Alzheimer's disease."