We R the Cure

Seeking Cures and Cheating Destiny


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JDRF Research News: Specific Protein May Help Beta Cells Survive in Type 1 Diabetes

JDRF-funded researchers find therapeutic potential of MANF protein to reduce beta cell stress in type 1 diabetes.

Image for Diabetes Advocates

I am a diabetes advocate. We R the Cure is a blog site dedicated to the persons living with Type 1 diabetes and the clincial researchers who are making positive things happen in our journey to a cure.

In the healthy pancreas of someone without type 1 diabetes (T1D), the hormone insulin (essential for turning food into energy) is produced, stored, and released in a normal “factory-like” process within pancreatic beta cells in response to glucose in the diet.

Early in the course of T1D, however, excessive or pathologic stress in beta cells compromises their ability to properly secrete insulin, triggering a cascade of events ultimately contributing to the beta cell death. Over the past several years, JDRF-funded researchers have found evidence that beta cell stress may play a role in the onset of T1D, and are exploring possible ways to stop it from occurring, thus potentially protecting beta cell health and maintaining normal beta cell function.

In April, JDRF-funded researchers in Finland released new findings in the journal CellPress that add another piece to the puzzle of beta cell stress and T1D.

Post comes from News release published at  http://www.jdrf.org.

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D-Blog Week is back in 2014; Goal is to connect, share our hopes, and change the Diabetes World

For the 5th year in a row, diabetes online writers from all over the world will be participating in a solid week’s worth of informative, educational, and inspirational blog posts. To find out everything you need to know about Diabetes Blog Week, click on the button to the right.

Click on the #Dblogweek buttoin

Diabetes Blog Week — Click to find out more details.

Can you join a blog party that’s already been going on for 5 years?

Yes, I’m going to jump in for the first time ever this week. That’s 7 blog posts in 7 days. OMG.  Let’s get the party started.

Today’s topic: Change the World – Monday 5/12

Let’s kick off Diabetes Blog Week by talking about the diabetes causes and issues that really get us fired up. Are you passionate about 504 plans and school safety? Do diabetes misconceptions irk you? Do you fight for CGM coverage for Medicare patients, SDP funding, or test strip accuracy? Do you work hard at creating diabetes connections and bringing support? Whether or not you “formally” advocate for any cause, share the issues that are important to you. (Thanks go out to Kim of Texting my Pancreas for inspiring this topic.)

Changing the world?

A few years ago, I won’t say how many, a very “Zen” co-worker of mine was fond of quoting inspirational slogans to inspire team members to overcome our every day, routine work challenges. At the time, my personal guru was a very non-Zen spiritual leader named Vince Lombardi, legendary head coach of my Super Bowl champion Green Bay Packers.

Needless to say, we didn’t have a lot in common. Funny thing, two decades later — after spending many days, weeks, months  and years working with volunteers at the local and state level to raise awareness and the critical funds for Type 1 diabetes research — I can admit it: My co-worker was right in sharing his quotes with us. With a shout out to my former colleague, Karl Bren, here’s the quote that fits perfectly with the diabetes online community (DOC) perspective:

“Never believe that a few caring people can’t change the world. For indeed that’s all who ever have. ”
Margaret Mead, The World Ahead: An Anthropologist Anticipates the Future    

So, if the Genie stopped by today and granted me 3 practical — not magical — wishes to change the diabetes world — here’s what I’d want to make happen:

  1. Remove the FDA’s ability to delay or drag its bureaucratic feet — to block cutting-edge insulin pump technology that is being used successfully in Europe.  Bring it to the USA. Now.
  2. Remove roadblocks so we can expand the research and exploration into stem cells and regeneration technology like the efforts now underway in California by ViaCyte. Let’s “wake up our unemployed pancreas” and bring it back to full employment producing beta cells and the insulin we need ON Command. (A related side wish — Bring back the missing limbs, bring sight back to the blind, and restore full health to the persons who’ve lived with Type 1 diabetes for decades and lost a few rounds with the killer. This one’s for you, Aunt Mary Jane!)
  3. Ask everyone to stop blogging, tweeting, snap chatting and every social media form of expression for 1 year — and go visit their next-door neighbor, siblings, family members, strangers and find ways to improve your own piece of the world. What’s your passion? What problems plague your community? If you have diabetes, cancer or any life-threatening disease — see if it makes sense  for you to volunteer for a human clinical trial. Jump in and encourage others to do the same. We need more trials so we can stop curing Mice With Diabetes and focus on Persons With Diabetes.

We are the world, we are the children, We are the ones who make a brighter day, So let’s start giving. There’s a choice we’re making, We’re saving our own lives. It’s true we’ll make a better day, Just you and me … We R the Cure!”

It’s Diabetes Blog Week, and this entry is for the “Change the World” topic.  For more on Diabetes Blog Week, including participants and topics, click on the respective links.  It’s not too late to join in the fun – jump in now!


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Mathematics, Mary Tyler Moore and Standard Deviation, Part 2: Looking for the Type 1 Auto Pilot Easy Button

One of the all-time great movie quotes, from Airplane circa 1980s, actually fits perfect for persons living with Type 1 diabetes who keep looking for a qualified pilot or Auto Pilot “Easy Button” to help them fly safe and keep their complex human body on course:

Photo of Auto Pilot Easy Button to push for diabetets control

Managing Type 1 diabetes is like flying a complex jet airplane. What we need is an Auto Pilot Easy Button to keep us flying level and safe.

“All right, Striker, you listen, and listen close. Flying a plane is no different from riding a bicycle; it’s just a lot harder to put baseball cards in the spokes.”

The more you know about your own diabetes, the less you understand. The more time you spend managing your diabetes, using the latest technology tools, aiming for a lower A1c and a lower Standard Deviation, logging in and learning from the Diabetes Online Community (DOC) — the less you actually comprehend about a chronic disease that is, actually, almost impossible to control. There is no Auto Pilot button in the T1D cockpit.

In the first four months of 2014, I’ve been hyper-focused or rededicated to my diabetes management. Thanks to my new tech partner, the Dexcom “Studio” reporting app, I’ve been monitoring my hourly, daily and weekly trends, adjusting basel and bolus rates based on pattern or trend lines,  and charting my own “success report” or flight plan.  Of course, a true “success report” for Type 1Ds would show a TAB that says: “CURED.” Sorry, but I have not found this category yet on the Dexcom app.

If you’re looking for good news, here it is: My quarterly check up in April produced my best A1c number in almost 2 years — a 7.5 A1c! This is down from my 7.8 A1c in January, and my better-than-average result also produced a Standard Deviation number of 51 for April — way, way down from my Feb/March SDs in the high 60s.  I am thrilled with the current trend line and I better understand how hard work, diet and exercise, paying attention to the mathematics of diabetes and some luck produces better blood glucose control and fewer serious medical complications. This cause-and-effect was established in  the landmark DCCT study done more than two decades ago. The Diabetes Control and Complications Trial (DCCT) showed that keeping blood glucose levels as close to normal as possible slows the onset and progression of the eye, kidney, and nerve damage caused by diabetes. In fact, it demonstrated that any sustained lowering of blood glucose, also called blood sugar, helps, even if the person has a history of poor control.

However, here’s where the mathematics, Mary Tyler Moore and standard deviation come back into the story:

How can anyone spend 24/7, 365 days a year — every year for the rest of my life — working this hard at a full-time job that brings with it no pay, no days off, no miracle cures,  and the uncertainty that better blucose control– the goal is under 7.0  A1c — actually reduces medical complications?  As the Mary Tyler Moore TV theme song might actually ask: “You might just make it after all?”

Despite my recent well-earned success, my monthly and quarterly results still show that I’m still spending about 30% of my days ” out of my target” blood glucose zone ( 80 to 170) and, therefore, I still have not achieved true “control”  and may face potential health risks as I age.

Graph showing my Diabetes Glucose Control

My Dexcom Success Report shows better “In Target” results but shows I’ve still got a long way to go to achieve auto glucose control over my Type 1 Diabetes.

Here’s what my flight crew told me this month about my Type 1 Diabetes and how I’m doing on my journey toward better, healthier outcomes.

My Endocrinologist: “I don’t look for a certain standard deviation number, whether that’s 50 or lower. The key is to get the number as low as possible.  Your A1c is moving in the right direction but it needs to be lower.”

My Dietitian — first time I’ve met with one in 10 years. “People with Type 1 have all these numbers running around in their heads. They are constantly thinking about glucose numbers, A1Cs,  carbohydrates and is their trend line going up and down. I think it gets to be a little overwhelming at times. You should give yourself some credit because you are managing things that a person with a normal, functioning pancreas never thinks twice about. My glucose numbers may be the same as yours in a given day, but I don’t spend a minute thinking about it because my pancreas is doing it for me.”

My Dexcom Rep who is also a Type 1 diabetic — “The most important goal is more stable blood sugars. Our goal should be below 50. Even below 40. Our bodies like stability. There is a lot more to diabetes than just controlling one measurement or number. There are so many factors and stress is one of the biggest. If you have a good day and your numbers are improving, that’s a good thing. But some of this is really out of our hands.  We are humans after all.”

I turn to technology to help best manage my diabetes because my pancreas stopped making insulin almost two decades ago, and these advances in treatment have improved my quality of life immeasurably in some ways (emotional health) and very measurably in others (better blood sugar control). The technology we need now is the Auto Pilot Easy Button — or the Artificial Pancreas closed loop system. Push it and it’ll be almost like your pancreas is flying the plane again.


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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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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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Clinical Trial News You Can Use: Psoriasis Drug Shows Promise, Tested As Type 1 Diabetes Treatment

The NursingTimes reports this on Oct. 3: “Skin drug shows ‘promising’ results on type 1 diabetes,” reports BBC News.

This story is based on a small trial of alefacept in people with newly diagnosed type 1 diabetes. The immune system of people with type 1 diabetes attacks the insulin producing cells in their pancreas. Most people with type 1 diabetes have to regularly inject themselves with insulin.

Alefacept is approved for use to treat the skin condition psoriasis in the US. Researchers hoped it might help people with type 1 diabetes, because both conditions are autoimmune conditions (where the symptoms develop due to the body’s immune system ‘malfunctioning’ and attacking its own healthy tissue). Alefacept suppresses one type of immune system cell associated with the autoimmune response, and the researchers hoped that it could also stop these cells from further attacking the insulin-producing cells.

Although the drug did not improve how much insulin was produced in the two hours after a meal, people taking the drug needed lower doses of insulin than those taking placebo and experienced fewer hypoglycaemia events – where blood glucose levels drop to an abnormally low level. These results should be seen as very preliminary, with larger and longer term trials now needed to determine whether alefacept does offer any benefit for people with newly diagnosed type 1 diabetes.


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Autoimmune Disorders: A Definition

An autoimmune disorder is a condition that occurs when the immune system mistakenly attacks and destroys healthy body tissue.

Normally the immune system’s white blood cells help protect the body from harmful substances, called antigens. Examples of antigens include bacteria, viruses, cancer cells, toxins, and blood or tissues from another person or species. The immune system produces antibodies that destroy these harmful substances. In patients with an autoimmune disorder, the immune system can’t tell the difference between healthy body tissue and antigens. The result is an immune response that destroys normal body tissues. With autoimmune disorders, the immune system reacts to normal body tissues that it would normally ignore.

What causes the immune system to no longer tell the difference between healthy body tissues and antigens is unknown. One theory is that some microorganisms (such as bacteria or viruses) or drugs may trigger some of these changes, especially in people who have genes that make them more likely to get autoimmune disorders.  There are more than 80 different types of autoimmune disorders. Here is a very small list of diseases that fall into the autoimmune category:

  • alopecia areata
  • autoimmune hemolytic anemia
  • autoimmune hepatitis
  • Crohn’s disease
  • dermatomyositis
  • diabetes (type 1)
  • Graves’ disease
  • Guillain-Barré syndrome
  • multiple sclerosis
  • psoriasis
  • psoriatic arthritis
  • rheumatoid arthritis
  • systemic lupus erythematosus
  • thyroiditis

For more complete information about Autoimmune Disorders, check out the National Institutes of Health website. It’s a great place to start your research.