We R the Cure

Seeking Cures and Cheating Destiny


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Ending the A1C Blame Game: Reposting a “Must Read” From MD on Insulin Nation

Research Corner: Ending the A1C Blame Game (via http://www.insulinnation.com)

When glucose sensors first became available in clinical trials some 2 decades ago, I decided to wear a sensor to compare my glucose levels as a non-diabetic individual with glucose levels of my patients. I was excited to have this new tool, which measured…


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Mathematics, Mary Tyler Moore, and Standard Deviation, Oh My! We’re Gonna Make It After All

The headline, I hope, made you stop and wonder. Math. Mary Tyler Moore. Standard Deviation? Three random sounding topics that actually have one thing in common: Living with Type 1 Diabetes, of course.  The balancing act is the perfect excuse to republish some of Mary’s best quotes — about her battle with the disease — on our complicated journey toward better health and cheating our destiny.

We R the Cure blog and photo of Mary Tyler Moore at JDRF Childrens Congress 2009

Mary Tyler Moore greets President Obama during the 2009 JDRF Children’s Congress event in Washington. DC. She is flanked by her husband, Dr. Robert Levine, and boxer Sugar Ray Leonard.

“Both children and adults like me who live with type 1 diabetes need to be mathematicians, physicians, personal trainers, and dietitians all rolled into one,” Mary has told members of the United States Congress during JDRF’s Children’s Congress. “We need to be constantly factoring and adjusting, making frequent finger sticks to check blood sugars, and giving ourselves multiple daily insulin injections just to stay alive.”

I also know that a photo — or in this case a You Tube video from @Blogdiabetes friend Tony Rose — is also worth a 1,000 amazingly insightful words from me, the CEO, Editor-In-Chief of “We R the Cure.com.” Right? As I learned in Journalism 101, it’s time to get to the “So What?” or “hook your audience now” or lose them forever sentence.

After living and dying in three-quarter time with Type 1 diabetes for 15+  years, I’m actually beginning to figure out how much effort, dedication, cool technology and sheer luck it takes to “control” my blood glucose. The answer: It takes every waking second of every day, and that still does not guarantee an A1C less than 7 or eliminate the rollercoaster blood glucose ride. I love coasters, but the more you learn about this crazy,  chronic disease, and the harder you work to control it using insulin pumps, meters, CGMs and Apps — It still winds up controlling you most days.

For the past 4 months, I’ve been religiously wearing my new DexCom 4 Platinum CGM — which I love. And, as the images here will show — my standard deviation has dropped from 68 to 58 and is approaching the 50 reading which, according to Laura Adams, Certified Diabetes Educator with DexCom, is the number persons with type 1 diabetes (PWD) should aim for when seeking to control their glucose. In fact, Laura says a standard deviation reading between 50 and 40 on my DexCom ” Studio” reporting App should be the target. Fortunately, calculating the SD number is done automatically by the App based on my CGM numbers. They’ve taken the math out of my hands.

In Part 2 of this blog story, we’re going to dive deeper into the math and determine if standard deviation, A1C or something called “Glycemic Variability” is the true “gold standard” of BG control?

For now, I’ll leave you with these positive trendlines from DexCom App, which does not sync up with my insulin pump App (Diasend) — but that’s another story. Let’s call this my starting point as I aim for better control with the goal of reducing the possibility of serious health complications such as blindness, heart disease, stroke and amputations. I am in charge of my own cure, and getting better control of my numbers is the key.

The good news: My numbers are getting better thanks to technology, effort and some luck. The sobering news: this is a 24/7 battle and there’s never ever a day off.  Don’t take my word for it, take it from my Type 1 best friend, MTM:

“Chronic disease, like a troublesome relative, is something you can learn to manage but never quite escape,” Mary explains on JDRF.org’s website. “And while each and every person who has type 1 [diabetes] prays for a cure, and would give anything to stop thinking about it for just a year, a month, a week, a day even, the ironic truth is that only when you own it — accept it, embrace it, make it your own — do you start to be free of many of its emotional and physical burdens.”

We’re gonna make it after all. We R the Cure.


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Are You Curious About ViaCyte’s Upcoming T1D Clinical Trials? Here’s More Information

Cross-Section Graphic of Viacyte's VC-01 Encapsulated Delivery System

The VC-01 combination product is expected to be implanted under the skin of the patient through a simple outpatient surgical procedure. The cells are then expected to further differentiate to produce mature pancreatic cells that will synthesize and secrete insulin and other factors, thereby regulating blood glucose, commonly referred to as blood sugar levels.

In the closing paragraph of my last blog post, I tried to strike a balance between hope and realism when describing ViaCyte’s VC-01 combination product and pending clinical trials aimed at a virtual cure for Type 1 diabetes.

The possibility/probability of successful clinical trials makes you anxious, optimistic, and fearful of another big letdown. It also leaves you with lots of questions. So I contacted ViaCyte to say “Thank You” for presenting at the JDRF Research Summit in Bethesda, MD last month  and asked a few follow-ups.  To my delight, I got an email response from a person named “Howard” at the San Diego-based company.

Q: How will you recruit or identify prospects for the upcoming clinical trials?

A: Currently, ViaCyte is still in preclinical development with our diabetes product VC-01; we are not conducting any clinical trials at present.  However, we do anticipate completing the necessary preclinical studies and filing an application with the FDA so as to be able to proceed with human trials sometime later this year.  Note that when the clinical trial starts, ViaCyte will adhere to Good Clinical Practice (GCP) guidelines, which preclude the Sponsor (ViaCyte) from having direct contact between clinical study subjects.

Q: How does the proprietary device ” KNOW” when and how much insulin to release?  Are the stem cells smart enough to automatically ” sense ” the amount of glucose in the body and respond in a measured fashion  just like a healthy pancreas does in non Type 1 Diabetics?

A: Yes, the cells contained in the device are smart enough to know when to secret insulin. Strictly speaking, the cells in the device are not stem cells. They are derived from stem cells but have undergone differentiation to a point where they are no longer considered stem cells. The most current information about our progress and technology can be found on our website.

Q:  Will clinical trial participants be required to take immunosuppressant drugs, and,  if this therapy works, will these drugs be required for the rest of the patient’s life?

A: At the present time we do not anticipate that any immunosuppressive therapy will be required, either during the clinical trial or at any time thereafter.

Q: Is there an age range for eligible human trial participants? If people are interested in the clinical trial or applying, how do they contact ViaCyte?

A: In our first clinical trial we anticipate that the age inclusion range will be from 18 – 55 years. Once clinical trials start, information on the location of clinical study sites will be available online at clinicaltrials.gov, the US government database of current clinical trials. Additionally, information should be available on our website once the trial is closer to launch.

Q: Finally, how will this implantable device actually cure my diabetes?

A: By acting essentially as a replacement endocrine pancreas, the source of insulin and other regulatory hormones produced in our bodies, ViaCyte’s VC-01 combination product has the potential to be a virtual cure for type 1 diabetes. The VC-01 therapy is the combination of:

  • PEC-01 cells: A proprietary pancreatic endoderm cell product derived through directed differentiation of an inexhaustible human embryonic stem cell line, and
  • Encaptra drug delivery system: A proprietary immune-protecting and retrievable encapsulation medical device.


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Encapsulated Cell Therapy Aims to Transform, Cure Type 1 Diabetes? ViaCyte’s Human Clinical Trials Coming In 2014

BETHESDA, MD (March 1, 2014) — Well, there you go again. Getting your hopes up for another possible ” cure” for Type 1 Diabetes. That’s what I told myself as I listened to Dr. Eugene Brandon, Ph.D. — an obviously intelligent scientist who was also able to speak in layman’s language — present his case at the JDRF Research Summit hosted by the Greater Chesapeake & Potomac Chapter of JDRF last Saturday.

As I listened and tried to understand the science behind his talk, it was difficult to stay realistic. If they can implant regenerative cells under the skin and these cells will function like  healthy pancreatic cells, then this crazy idea just might work for some children or adults living with T1Ds. So my next question was: When is the first human clinical trial and how do I sign up? Damn the risks; my time is running out. That’s what went through my mind and probably a few others listening to him speak.

Before I booked my flight to San Diego, I settled down and realized one simple fact: I’m attending a diabetes research summit where “hope” is always the key word. Dr. Brandon,  Director of Strategic Relations & Project Management at San-Diego based ViaCyte, spoke to a full ballroom of  T1Ds and their families at the Bethesda North Marriott during the 4th annual JDRF Research Summit.  Dr. Brandon talked about his company’s VC-01™ combination product. It is a stem cell-derived, cell therapy product that the company believes could transform the way patients with Type 1 diabetes manage their disease.

The product is comprised of pancreatic progenitor cells contained in a proprietary device that is designed to be inserted under the skin.  Upon implant, the product is expected to vascularize as the cells further differentiate to islet-like structures that generate insulin and other expected regulatory factors in response to blood glucose levels, essentially providing patients with a replacement for the cells lost as a result of the disease. The company has reviewed the VC-01™ combination product development plans with regulatory authorities at the US Food and Drug Agency and Health Canada.

By acting essentially as a replacement endocrine pancreas, the source of insulin and other regulatory hormones produced in our bodies, VC-01 combination product has the potential to be a virtual cure for type 1 diabetes. The VC-01 therapy is the combination of:

  • PEC-01 cells: A proprietary pancreatic endoderm cell product derived through directed differentiation of an inexhaustible human embryonic stem cell line, and
  • Encaptra drug delivery system: A proprietary immune-protecting and retrievable encapsulation medical device.

Pending regulatory authority review of its planned application, ViaCyte is planning to initiate clinical development in patients with Type 1 diabetes this year!  As he finished his presentation, Dr. Brandon answered a few of the lingering questions from the optimistic but realistic Type 1 Summit attendees.

The testing has worked in mice. But is it safe for humans?

“By all accounts, it is a stable product. Our testing shows it stays stable for the life of the animal,” Brandon said. “If we can get this biological process to work, we think we can replace the damaged islets.” The company also has developed a process for inserting and removing the implanted device quickly. “Something like this has never been tested in humans before.”

When will human clinical trials begin?

“We think we’ll be in pretty good shape to get this ready and approved by FDA for a first human trial planned in 2014,” Brandon said, adding that his company has already held discussions with the FDA on their proposed timeline. “You don’t want to spring something like this on the FDA.”

What is the lifecycle of the implanted device? 

“That is the million dollar question to be determined in the clinical trial,” Brandon said. “How long will this last if it works?” Because the cells are contained in a ” tea bag” type of container, it is anticipated that the body’s immune system will not strike or reject the foreign object. “Theoretically, these implants could last for many years.  That is the purpose of the clinical trials. We will start learning things that can only be discovered in a human clinical trial.”

At the end of the summit, I left with renewed hope for a cure and the sober realization that this chase for a miracle is nothing new to persons living with all types of deadly diseases. In fact, the JDRF was formed 40+ years ago by parents of children with Type 1 diabetes who were committed to pushing faster to fund a cure.  In seeking a cure, we all jump into the fountain of scientific hope. Compared to the quality of life for diabetics before the discovery of insulin in 1921, Type 1 diabetics are living in a golden age of scientific and technology success. Things are improving at a rapid pace. So we keep chasing the illusion and hope to cheat our destiny for one more hour, for one more day, for one more year. Until there’s a cure … we march on.


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Matchmakers for Clinical Trials: Corengi Launches Free “eHarmony” Search App For Diabetes Research

It’s time to admit my deepest, darkest secret:  I frequently visit an online dating service. I search the site and view the long list of prospects late at night when my wife and family are sleeping.

Unfortunately, it is almost impossible to find my perfect match, and what do I really know about my government-sponsored online dating service? In the morning, after a night of searching, I wake up tired and unsatisfied. However, when it comes to finding a match, I am totally committed to the search.

OK. Relax. And don’t call my wife. I’m talking about diabetes human trials and the lack of a user-friendly search application to make this less cumbersome for individuals who wish to find a match. Thankfully, this may all change soon thanks to the efforts of Ryan Luce and his company, Corengi, which provides a Clinical Options Research Engine to match open trials — for all types of chronic diseases — with the patients willing to participate in the search for a cure.

“That’s interesting that you used that term because we also see the need for an ‘eharmony’ search application,” Ryan Luce, the president and founder of Corengi, said during a recent telephone call. “Our goal is to simplify and improve the search process and to build a large database of qualified participants.” Ryan said the new online effort is a demonstration project focused on Type 2 diabetes with some financial support coming from an NIH grant and other investment capital.

Ryan said Corengi is committed to building a comprehensive, free, and open interactive platform that will allow stakeholders within the clinical trials community (investigators, site personnel, sponsors, and disease advocates) to engage with potential enrollees and educate them about specific clinical trials.

Photo of Corengi's Ryan Luce

Ryan Luce is president and founder of Corengi, a Washington-based digital firm

At this point, the Corengi App connects persons with Type 2 diabetes with open clinical trials — and it is quicker and easier to use than searching the government’s Clinicaltrials.org site. Ryan told me the interactive database has more than 400 Type 2 trials today and is growing daily. Offering a Type 1 diabetes search application, the one that I care about,  will take a little longer to develop because there are more complex data variables to account for than in Type 2 trials ( i.e.  does the patient wear an insulin pump, do they wear a CGM, when were they diagnosed, what is their A1c, etc.)

It is awesome to see that Corengi is close to launching a Type 1 clinical trials search engine. The need for this product is clear. If you make a diabetes online search or view my twitter page on any given day, you’ll see a lot of great trials are happening across the world. When you read these stories closer, however, you’ll also see a common theme: Researchers need more humans to participate in Type 1 and Type 2 diabetes clinical trials.

Finally, Ryan says the good news for Type 1 diabetics is that Corengi is not the only business pursuing this solution. “There is an entire industry growing up around this online recruitment idea, and we intend to be a part of the solution,” Ryan said.

Ryan spent most of 2000-2009 working for healthcare technology company NexCura, which was acquired by Thomson Reuters in 2005 and then sold to US Oncology at the end of 2009. NexCura has educational tools that are embedded on a variety of websites, including several of the most prominent advocacy groups. As Director of Product Development, he developed completely new product lines in clinical trial recruitment, market research, and physician messaging. Ryan earned his B.S. in Chemistry from Duke University in 1994 and his Ph.D. in Bio-Organic Chemistry from the University of Washington in 1999.

Ryan sounds like he’s got the technical and business savvy to make this application a success. As a clinical trial participant, I wish him continued success, and when he gets the Type 1 App ready, I’ll partner with him to post it here on WeRtheCure.com for everyone to check out. Thanks Ryan for using technology to produce better solutions and, hopefully, a cure for persons living with diabetes. Together, We R the Cure.


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2013 Blogging Year In Review: Thanks For Visiting We R The Cure

The WordPress.com stats helper monkeys prepared a 2013 annual report for this blog.

Here’s an excerpt:

A San Francisco cable car holds 60 people. This blog was viewed about 2,200 times in 2013. If it were a cable car, it would take about 37 trips to carry that many people.

Click here to see the complete report.


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Clinical Studies Are Recruiting for Participants; We R the Cure — Is It Your Time?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge.

Before leaving UVa and giving back the AP, I pose with a few of the team members who watched over me and conducted the outpatient trial. L to R: my nurse, Crystal Leathers, computer engineer Benton MIze, and Stacey Anderson, MD.

Before leaving UVa and giving back the AP, I pose with a few of the team members who watched over me and conducted the outpatient trial. L to R: my nurse, Crystal Leathers, computer engineer Benton Mize, and Stacey Anderson, MD.

There are two main types of clinical studies: clinical trials and observational studies. ClinicalTrials.gov includes both interventional and observational studies.

Searching for a Type 1 Diabetes Clinical Trial? Check out the current list of trials in the United States.  Searching for a Type 2 diabetes clinical trial?  Click this link.


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Spare A Rose, Save A Child : Can You Spare $5 or More To Deliver Insulin

Sometimes, all you have to do is Stop, Look, and Listen. Then you see the blessings surrounding you and give thanks.

Visit Spare A Rose Save A Child website to donate

Click here or visit http://www.p4dc.com/spare-a-rose/ for more information

I have several unopened vials of Insulin in my refrigerator waiting to be used thanks to my health insurance and my co-pays. It still costs too much. However, I have it. Without insulin, persons with Type 1 diabetes would look pretty darn weak, sick or worse. But that’s another story for another day. Today, it’s time to raise some awareness.

The International Diabetes Federation runs a program called Life for a Child. Life for a Child provides insulin as well as other diabetes supplies and education to more than 12,000 impoverished children living in 43 developing countries. Without this help, there is a good chance they would not survive. In some areas, the life expectancy of a child with type 1 diabetes is less than one year.

In honor of Valentine’s Day, the Diabetes Online Community is spreading the news about the “Spare a Rose, Save a Child” campaign encouraging people to spend the amount they would spend on one rose to save the life of one child. Just five dollars will help support a child for a month. A dozen roses would help a child for a year. The IDF’s goal for 2014 is to raise $10,000!

Insulin was first invented in 1921. It’s not a cure, but no one should die from diabetes in 2014 because of lack of insulin. Insulin is available. So let’s get it to those who need it most. Thanks for your help!


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Researchers Agree: The Status Quo Is Not Acceptable; We Need More Clinical Trial Participants To Drive Progress

Imagine my surprise and excitement when a leading Type 1 diabetes researcher, Dr. Desmond Schatz of the University of Florida, unofficially promoted our “We R The Cure” blog site during the JDRF Type 1 Diabetes Research Summit on Feb. 18, 2012. Let’s roll the audio tape:

We R the cure JDRF walk team

We R the Cure — and so are you. Sign up for a clinical trial today.

“We do not have enough people participating in research studies,” Dr. Schatz told several hundred Type 1D enthusiasts in his opening statements. “My goal is to give you hope, to inspire hope, and to push you to get involved. Without U, there can be no cure.” Almost on cue, an outburst of applause came from the adjacent ballroom where young children with Type 1 diabetes were playing and having fun while their parents attended the JDRF Summit. Dr. Schatz heard the applause and laughed. “I am here to make it clear, that the status quo (in Type 1 research) is unacceptable!” And again, the children cheered right on cue.

This blog is dedicated to the patients, doctors, nurses, researchers and big thinkers who are actively pushing research forward – in our search for solutions & cures for persons living with auto immune disorders such as type 1 diabetes and certain forms of cancer that are tied indirectly to weakened immune systems or a virus attack. If you’re ready to learn more or join a clinical trial, check back here often for news and information. Or simply click on Clinical Trials to get started.

My name is Mike Anderson, and I am the creator and editor of We R The Cure. I received my Type 1D diagnosis — from out of nowhere — in May 1998. Together with my friends and family, I am a passionate advocate for raising awareness and raising dollars for research and real solutions that will improve the quality of life for children, teens and adults living with this chronic disease. And one day — A cure or many cures.

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge.  There are two main types of clinical studies: clinical trials and observational studies.    ClinicalTrials.gov includes both interventional and observational studies. So, what R U waiting for … Think about joining a clinical trial in 2014. It’s a new year’s resolution that is worth keeping. Thanks for your participation. werthecure.com


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Resolutions To Keep In 2014: One Small Step For Man, One Giant Leap … For Diabetes Awareness

Welcome back to We R The Cure, 2014 Edition. I am happy to be back among the Diabetes Online Community.

Artificial Pancreas Closed Loop System

Artificial Pancreas Closed Loop System

Yes, I’ve been away enjoying Christmas, New Year’s, working, searching for new work and — most importantly, focusing on what matters the most to me: Family, Friends and Faith. If you guessed that what matters most is my Type 1 D, well — you were close but wrong. Of course, it should have been a multiple choice answer.

If you are a person living with Type 1 diabetes, managing your sugar highs and lows is  ALWAYS on the list of what matters most. Healthy and active on the outside; dealing with a chronic, life-threatening disease on the inside. It is a frustrating condition for the 3 million Americans — toddlers, children, teens and young adults — living with it.

A new year is here, and it’s time for me to join the “New Year Resolutions” chorus and to get my editorial content calendar back ON THE GRID. So here goes my Top 5 list of what We R The Cure will focus on in 2014. Of course, the numerical ranking may switch or slide during the year. What is number 1 today, may be number 2 by year’s end. But you get the idea.

  1. Tell the story of my Aunt Mary Jane.  A Joslin Center Medalist who’s been living with Type 1 diabetes for 7 decades and is still waiting for the cure they promised her back in the 1940s. She’s a survivor who has lived the ups and downs of diabetes since the age of 7. She’s got a story to tell.
  2. The focus of ” We ” R The Cure is the amazing Type 1s, the researchers, the doctors, and the clinical teams pushing hard to bring tech solutions like the Artificial Pancreas to market. The focus is on all clinical trial participants. If you are participating in a clinical trial and want to tell your story — please contact me. Your story needs to be told. And we need to encourage more Type 1Ds to seek and participate in clinical trials. We need more guinea pigs.
  3. Research and technology “News that we can use.” As a former reporter, my job is to highlight and interpret the daily digest of exciting and confusing news surrounding Type 1 and Type 2 diabetes.
  4. Wearing My new DexCom 4 and, hopefully, the DexCom 5 in Clinical Trials at the Center for Diabetes Technology at UVA. The DexCom 5 will send its results directly to the Artificial Pancreas smartphone and not to the transmitter. This must be tested and proven successful before “Home” AP trials can begin in 2014.
  5. Biking for the Cure in 2014. Finally putting this on my ” bucket list” and doing it. The target goal: Riding 60 or 100 miles, raising money for diabetes research, and keeping a journal about my training and crossing the finish line.

 

OK, there it is. I’ve placed my resolutions and goals online. WeRThe Cure is ready for another year — year 16 — of balancing life and diabetes. With the love and support of my spouse, family and friends — 2014 will be another great year.

Thanks for reading. Please comment or share ideas or stories.

Mike Anderson

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