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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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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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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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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Diabetes Technology: What Patients Really Want — The Video

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