I believe in the work they are doing and they are the horse (OK, the artificial pancreas system) I am backing until there is a biological cure. I know my body and I know that I need the glucagon portion of this system to keep my blood glucose levels in range.
I’ve donated before and I will again to this…And I’d love for you to read on and hear what they’re doing. We’re so close. And you can help.
From The Bionic Pancreas Team:
Exciting innovative work is being done at Boston University that is focused on profoundly improving outcomes in type 1 diabetes and substantially reducing the burden of diabetes management. Ed Damiano and his team have developed the one and only fully integrated, fully automated bihormonal bionic pancreas. They have done so in large part from charitable donations from the type 1 community. I support this project.
I am asking for your help. I invite you to look at the work that they have done, the results of multiple outpatient trials that they have completed with their clinical collaborators across the US, and the iLetTM, which was unveiled in July 2015 at the Friends for Life Children with Diabetes Conference in Orlando, Florida.
Ed and his team need our help to bring this to children and adults living with type 1 diabetes. After looking at this information, I am asking you to donate to this project.
Boston University is a 501(c)(3) organization, so your donation is tax deductible. Boston University assesses no overhead on your gift, so 100% of your donation goes directly to a dedicated account set aside for the Bionic Pancreas Project.
Without our help, this project may encounter a delay from their goal of conducting the final pivotal trial in 2017. These are the trials needed in order to submit the device for final FDA approval.
While Ed’s group has received funding from the NIH, the Helmsley Charitable Trust, and the JDRF, this money has funded the clinical studies, not the development of the device itself. The project needs at ~ $1.5 million this year in order for his team to remain on track with their device development efforts.
I have included some information from their website as well as links to more information. I have also included a pledge form. If you need more information or have any questions, please feel free to reach out to me or Scott Scolnick on the Bionic Pancreas fundraising team.
His contact information is Scott Scolnick, M.Ed., firstname.lastname@example.org, 617-608-7362.
Thank you in advance for your support.
Introducing the iLet
Built-in wireless CGM technology
Using Dexcom CGM technology, the iLet offers its own, built-in, continuous glucose monitor. All that is required is a Dexcom sensor and transmitter and the iLet will replace your regular CGM receiver.
No separate processor, all the smarts are already built-in.
No longer do we need a laptop or an iPhone to run our insulin and glucagon dosing algorithms; the iLet brings with it a dedicated platform to run all of our dosing algorithms on a single, handheld device.
The iLet is an automated, personalized diabetes management platform that automatically learns your insulin requirements and automatically adapts its insulin dosing to your ever- changing needs, allowing you to focus on the rest of your life.
Two pumps in one
Streamlined, simple, and friendly user-interface
A touch-screen display brings all the information you need right to your fingertips through an extremely simple and elegant user-interface.
NOTE: The iLet is an investigational device and is not yet FDA approved. Our goal is to conduct human factors studies and begin clinical trials testing the iLet in 2016.
Help This Become A Reality And DONATE today by clicking this link.
Donations support the Bionic Pancreas Project at Boston University. 100% of your gift is tax deductible, and goes directly to the work being done on the one and only fully integrated, fully automated bihormonal bionic pancreas.
The infographic is not flattering, and like everything related to statistics, not entirely truthful. (JDCA even admitted in a post on FB that they made some “judgment calls” in their numbers.)
At first, I ignored the repeated posting in Facebook groups of how JDRF and ADA have not done enough to find a cure for us, but after a while, the bashing became nothing but a “I hate these organizations and I’ll never donate to them again. How dare they take our money and do nothing.”
I spoke up and reminded individuals in those groups that there are MANY ways to use the donations raised through walks and rides and other fundraising opportunities, but that ALL of the donations were being used to help people with diabetes, whether it be for research or for support. (And I also reminded them that there was a marked absence in this infographic of where one should be donating…)
My opinion voiced, I went on my merry way, living my life with diabetes, until I got an unsolicited email yesterday from someone claiming to be an employee of JDCA, asking me to promote, on my blog and through social media channels, their petition to the major diabetes non-profits, DEMANDING that JDRF and ADA use 30% of all donations for “practical cure research” through my blog.
Thank you for the invitation, JDCA. I’m going to pass.
Instead, I’m going to take my blog and use it took peek into what your privately funded non-profit, founded by the CEO of Activision Blizzard Entertainment (and a parent of a child diagnosed with Type 1 diabetes at the age of 2) wants us to focus on, rather than telling us what JDRF and ADA isn’t doing.
As I began writing this and hit 2500 words, I realized that this needs to be digested in more than one sitting, so I’m splitting this into 2 blog posts. (Mostly, because no one except masochists read 2500 words of my blog at a time and because I WANT YOU TO READ ALL OF THIS IMPORTANT AND UNBIASED INFORMATION.) Today, I’m covering just the Transplantation “practical cures” and you’ll get the others tomorrow in Part 2.
Juvenile Diabetes Research Alliance
According to a WSJ article, Mr. Kelly’s family foundation, the Brian and Joelle Kelly Family Foundation, has donated $1 million dollars (as of the 2013 article stated) to JDCA. The goal of JDCA is to help donors “become educated about charities that are focused on a “practical cure” for Type 1 diabetes.
Note: Hey, I have no problem with the fact they have spent $1 million dollars to create a “watchdog” organization. They could have spent it on a boat or a house or funding one of their “practical cure” projects. If you’ve got money, you also have the right to spend it as you see fit. I also believe in watchdog organizations, as long as you provide factual, correct, public-facing information.
The Juvenile Diabetes Care Alliance states that they want a “practical cure” by 2025. For their definition, a “practical cure” meets the following four criteria:
- Minimal Monitoring (checking BGs less than once per week and a A1C between 5-7%)
- Being able to sleep without worrying (about hypoglycemia or hyperglycemia)
- Being able to eat whatever one wants without having to evaluate carbohydrate intake
- Minimal side effects, understanding that some insignificant side effects are “acceptable”
Sounds reasonable, right? I’m all for that, because that elusive “don’t have to do anything ever again, it’s like magic and you don’t have to think about diabetes for the rest of your life” is a dream.
It then begs the question: What is JDCA’s idea of a practical cure?
JDCA’s Four Ideas of a “practical cure”:
- Islet cell transplantation
- A device that mimics the pancreas
- Glucose-responsive insulin (“smart insulin”)
- Modification of the immune system (blocking, balancing, and/or retraining)
Again, sounds reasonable, right? Some of these practical cures are beginning to look like they may not make the 2025 timeframe cut-off, but you never know, right?
Every year, JDCA issues a report that tells potential donors which “practical cures” are more likely to pull ahead. Here are the 2014 “Potential Practical Cure Solutions,” found in the JDCA State of the Cure report. (2015 hasn’t been published yet, but expect it in the fall as in previous years) - and I’m going to show you where the funding is coming from.
JDCA’s 2014 Potential Practical Cure Solutions
These solutions are broken down by type of “practical cure” and gives you the basic info into what it is, where this is in terms of “potential” release into the community and who is funding it. (For my own personal curiosity, I have delved deeper into some than others.) As a reminder, Part 1 is ONLY transplantation. Part 2 is the rest of the “practical cures.”
(ViaCyte - a privately held, for profit company)
-San Diego, CA
What it is (straight from ViaCyte’s website):
ViaCyte’s innovative product is based on the differentiation of stem cells into pancreatic beta cell precursors (PEC-01™), with subcutaneous implantation in a retrievable and immune-protective encapsulation medical device (Encaptra® drug delivery system). Once implanted, the precursor cells mature into endocrine cells that secrete insulin and other hormones in a regulated manner to control blood glucose levels. ViaCyte’s goal is a product that can free patients with type 1 and type 2 diabetes from long-term insulin dependence.
Where it is in the pipeline of “practical cure”:
ViaCyte, Inc. announced in July 2014 that it had filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence. This first-in-human trial will evaluate the safety and efficacy of ViaCyte’s VC-01™ product candidate, a stem cell-derived, encapsulated cell replacement therapy. ( Viacyte’s website)
They are in Phase I/II clinical trials at two locations, with an expected trial end date of August, 2017 with an estimated enrollment of 40 participants. Note: According to Wikipedia, “The percentage of Phase II trials that proceed to Phase III, as of 2008, is 18%.” Estimated commercialization date is unknown, but safe to say more than five years off.
Who is funding this “practical cure”?
JDCA forgets to include this:
JDRF is a major funder.
ViaCyte has received substantial financial support from both the California Institute for Regenerative Medicine (CIRM) and JDRF. (Direct from the front page of ViaCyte website.)
Additional funders/partners include: Cellular Dynamics International, Invitrogen, now a part ofLife Technologies, Nestlé Institute of Health Sciences, Seventh Framework Programme, StemCell Technologies, Johnson & Johnson Development Corporation, Sanderling Ventures, Asset Management, BD Ventures LLC, Hospira, Inc., Portage Venture Partners, and The Clayton Foundation.
Note: What happens when/if it becomes commercially available? Janssen has signed an agreement with ViaCyte.
The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01™ combination product that ViaCyte is developing for type 1 diabetes. This right will continue through the initial evaluation of clinical efficacy of VC-01. ViaCyte received $20 million from Janssen and Johnson & Johnson Development Corporation (JJDC). The payment included a rights fee and a note convertible into equity at a later date. JJDC has been a long-standing investor in ViaCyte.
(Living Cell Technologies - a multinational for-profit in a joint venture with DOL)
- New Zealand, Japan
What it is:
DIABECELL is an insulin-producing cell product derived from pigs for the treatment of type 1 diabetes. These islet cells are self-regulating and efficiently secrete insulin in the patient’s body.
The treatment involves introducing encapsulated pig cells into the patient’s abdomen in a simple laparoscopic procedure. Living Cell Technologies’ unique proprietary encapsulation technology prevents the islet cells from being attacked by the patient’s immune system. This allows the use of cell therapies without the need for co-treatment with drugs that suppress the immune system, which often have negative side effects.
Where it is in the pipeline of “practical cure”:
To date, a total of 46 patients have taken part in clinical trials of DIABECELL. The goals of these trials have been to find the optimal dose required for DIABECELL and to obtain early indication of its effectiveness in controlling type I diabetes. These trials showed that DIABECELL has the potential to significantly reduce the number of unaware hypoglycaemic events that people living with Type I diabetes experience, whilst also reducing their insulin dose and not experiencing a rise in HbA1c.
DOL is now preparing for a larger Phase II/III study to more fully determine the frequency and extent of this benefit.(Taken from Diatranz Otsuka Limited (DOL) website.)
The clinical trial results for DIABECELL are located here.
Phase I/IIa safety study (Russia) - Two out of the eight trial patients discontinued insulin injections for up to 32 weeks. (The assumption being that after 32 weeks, they resumed insulin injections.)
According to Seeking Alpha, an investment media company: “Mostly, the results are more modest involving decreased insulin injections and significant reduction in unaware hypoglycemic events.”
There are currently no clinical trials offered through Clinical Trials.gov (a global trial locator).
Who is funding this “practical cure”?
LCT is an Australian for-profit company with headquarters and operations located in New Zealand. They have a joint venture with Diatranz Otsuka Limited (DOL). In June of 2015, DOL announced:
Diatranz Otsuka Limited (DOL), is to concentrate its research and development activities in supporting the development of DIABECELL® in the United States. As a consequence, research, development and manufacturing of DIABECELL in New Zealand will cease and there will be a reduction of staff at DOL’s headquarters in Auckland.
Otsuka Pharmaceutical Factory, Inc. (OPF), DOL’s 50% shareholder, is full sponsor and funder of the US program, operating under and exclusive license from DOL for US development and commercialisation of DIABECELL. Since securing the license, OPF has made positive progress, establishing a solid partnership framework for the US development.
DOL’s know-how, research to date and clinical experience in pig islet transplantation will be actively combined with OPF’s global drug development expertise and these partnerships to further strengthen and expedite the US development program.
This alignment of DOL’s expertise with the US program is part of DOL’s previously announced commitment to focus on the US development and FDA approval of DIABECELL. Once registered in the US, DOL retains a royalty free right to commercialise the FDA approved product in the rest of the world.
And of greater interest, Seeking Alpha says of DOL:
Otsuka is a formidable Japanese company with an established presence for its products in the US. Most notably its Abilify antipsychotic drug (shared with Bristol-Myers Squibb (NYSE:BMY)) generated $6.5 billion in US sales in 2013 (a top 10 US drug). To show it is no shrinking violet, Otsuka is involved in a fight to keep out generic versions of Abilify by suing the FDA!
Here is the press release from OPF.
None of these companies are non-profits and expressly state that they will sell and commercialize this product. They have not requested funding for cure research from the public.
ßAir Bio-Artifical Pancreas
- Tel Aviv, Israel
What it is:
The ßAir Bio-artificial Pancreas is a macrocapsule that contains islets of Langerhans, cells from pancreatic regions of the body that contain hormone-producing beta-cells. The macrocapsule provides a fully isolated environment for the islets to thrive. The islets in the bio-artificial pancreas replace the function of the endocrine part of the pancreas; i.e., the sensing of the level of glucose in the blood and the regulation of the production of insulin and glucagon as needed.
ßAir has the potential to ‘normalize’ the lives of people living today with type 1 diabetes. How? Of greatest importance, the ßAir bio-artificial pancreas eliminates the need for frequent glucose testing and insulin injections. Immunosuppressive therapy, which has many side effects, is also not required.
Note: as the ßAir device contains ‘living’ cells, the patient must commit to keeping them healthy. Once every 24 hours, the patient needs to refill the air in the device using a replenishing device which includes a dedicated injector. This guarantees that the cells will have the requisite oxygen supply to thrive and perform their insulin and glucagon production role.
Replenishing the device is performed by injecting oxygen into one of two ports implanted under the skin. The replenishing device is very user friendly, requires minimal technical skills for operation, and has very few possibilities for incorrect operation. The replenishing procedure takes just about two minutes. An alarm will trigger if something has gone wrong. (Beta O2 Website)
Where it is in the pipeline of “practical cure”:
Phase I/II clinical trial being conducted in Sweden. Last verified in December, 2014 with a study completion date of March, 2016. 8 people are to be enrolled in this study. No results have been reported.
Who is funding this “practical cure”?
JDCA forgets to include this:
Here’s the list of additional investors. As of this time, there has been no appeal to the general public for donations.
My Conclusion from Part 1:
For all the talk about JDRF not helping to fund a “practical cure,” I’m here to show you that JDRF is helping. Perhaps not to the extent that JDCA deems acceptable.
Who is JDCA to determine how much is acceptable?
Their “survey” of 1,000 donors in 2014, conducted by a third party (but where did they get their donor responses? Ask yourself that as they didn’t publicly state it in their report) claims that 88% of donors want their donations to go to “cure research.” The questions were targeted to invoke “cure” responses.
And before you jump on me saying that I’m a shill for JDRF (or ADA, who hasn’t been mentioned by me yet)… be very aware of this fact:
I donate to one of the “practical cures” that JDCA touts.
I’ve asked others for their help in funding this “practical cure.” I also donate to other diabetes non-profits, some big and some small, because I know (from my own thirty-two years of T1 diabetes) that while
I would sell everything I own to have a cure, crawl across a minefield strewn with broken glass to not have this horrible disease haunt me…
in the meantime, we need support and research for the complications from this disease.
Every time a parent complains about a school issue in the US, every time a child gets a T1 peer or mentor, every time a teenager goes to a summer camp where diabetes is the norm, every time a family member views their loved one’s BG graph on a device from miles away… those donations matter, too.
Conclusion: DO. YOUR. OWN. RESEARCH.
More information is coming in Part 2, including JDCA’s practical cure solutions: devices (1) and immune system modifications(4).
Don’t be surprised. Or disappointed.
I was told in 1983 there would be a cure in five years. I’ve waited this long. We’ll all be waiting a little longer.
* I have chosen not to link to JDCA’s website. On purpose. They’re easy to Google if you want to see what I did. I’ve linked to the deep dive stuff.
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If only everything was that easy.
Perhaps it’s because my sleep patterns are off (a combination of jet lag that still haunts me and a four-year-old who thinks it’s fine to wake me up at 2am because [insert a four-year-old’s logical excuse here]), but when I thought about change, all that came to mind was the old SNL skit about First CitiWide Change Bank.
“At First Citiwide Change Bank, We just make change.”
“We will work with the customer to give that customer the change that he or she needs. If you come to us with a twenty-dollar bill, we can give you two tens, we can give you four fives - we can give you a ten and two fives. We will work with you.”
The topic for today’s Diabetes Blog Week post is about change:
Either tell us what you’d most like to see change about diabetes, in any way. This can be management tools, devices, medications, people’s perceptions, your own feelings – anything at all that you feel could use changing.
I’ve seen a lot of changes in the last three decades when it comes to diabetes management.
We changed exchange lists (Oh, how I hated the “2 Breads, 1 Meat, 1 Fat, 1 Milk” mentality!) for counting carbs.
We changed blood glucose meters that took two minutes for a reading to ones that give that reading in five seconds.
We changed syringes with long needles for short needles, mixed pork and beef insulins for analogues.
We changed insulin pumps for better insulin pumps and inhaled insulin devices.
I’m not saying that these changes are bad. They’re not. They’re prolonging lives and making diabetes more manageable.
But we’re still just making change.
I want a cure.
It’s been a year, yo. A whole year.
On March 6, 2013, this blog roared into existence after an announcement of a potential cure for diabetes turned out to be a ploy for donations. (You might see it differently, but that’s what it looked like to me.)
I still have diabetes.
Want to know what happened after the trumpeted announcement? The Diabetes Research Institute has raised $4 million dollars. That’s what the last press release told the world. The BioHub is still vaporware, an idea that, while beautiful in design, is far away from being a reality.
What the BioHub has done for me has been anything but vaporware. It’s given me a perspective that I didn’t have before March 6, 2013. And a renewed sense of purpose.
We all want a cure, but what flavor… Vaccine? Transplantation? Artificial Pancreas? Some individuals and associations focus their funding, voices, and time for the “There must be a cure as soon as possible!!” and damn everything else. There are others (I’m raising my hand…) that focus upon living well with the disease. It’s not that we wouldn’t welcome a “cure”, but we also recognize that it’s still a long way off, so until then, the tech and the drugs and the support that keep us alive need to be as accurate and advanced as possible.
I see that sometimes these two views are at odds with each other. The parents of newly diagnosed children tend to be of the first camp and that’s perfectly fine. As I’ve mentioned before, the “cure in five years” has rung hollow six times over for me. It’s painful for me to watch the light slowly dim in their eyes as they come to realize that it’s just not that simple. Those like me who want to live well welcome them with open, comforting arms when they do step over. There’s plenty of room. And don’t think I don’t appreciate those who stick to the “CURE!” camp. I need them to keep rallying.
We all live with hope in our hearts. A cure for what ails us. No more external insulin. No fear of going to sleep and not waking up (or waking up with a gaggle of paramedics around you…). No kidney disease, retinopathy, heart disease, aches and pains and decision fatigue.
But in the meantime, I’m happy to be ThePerfectD, surrounded by the incredible Diabetes Online Community and the researchers and organizations who walk with me everyday. I’ve written approximately 166 blog posts (some were images, so I can’t say “write” for all of them…), attended conferences and summits, worked with other advocates to change the way the federal government looks at us, made amazing new friends, and have embarked on a few projects that will hopefully (crossing my fingers, toes, and any other body parts that I can cross) be an asset to the diabetes community at large.
Thank you for sticking with me for the past year. I’m a better person because of you. You inspiration. Your support. Your voice.
Thank you for letting me be ThePerfectD, especially when I am anything but perfect.
The stagecoach pulls up, generating a dust cloud out of which emerges a foppish, yet dapper man with a big handlebar mustache and an even bigger smile. He hefts several battered, sturdy leather cases off the back of the wagon and sets them down around him, surveying the area for the best place for him to set up shop.
He’s here to make a fast buck, hustling oils and liniments that will cure everything from melancholia to thinning hair. That snake oil salesman will talk a mile a minute, promise the world, and then when the getting’s good… he’s off to the next stop to swindle more unsuspecting rubes. Melancholia remains. Hair continues to thin.
It may not be the Wild West anymore (which is good, because I’d be dead before I could wear a corset), but the stagecoach remains; these days, it’s called the Internet. The snake oil salesmen (And women, because we’ve come a long way, baby!) use videos and pretty pictures to sell their cures - and these charlatans are everywhere.
This morning, after a curious comment on a diabetes FB group, I did some fast research - and found digital snake oil. This particular individual in his six minute video claimed to be “cured” of his Type 2 diabetes and for only… get this… $97 per month… will give you his roadmap on how he did it and get you access to his diabetes expert (who is a doctor who writes diet books).
There was no “free trial” and there was no “guarantee” - just a guy who claims to have been diagnosed in 2002 and weaned himself off all of his medication after hearing from doctors that he needed to begin an insulin regimen. He actually states in his video that he repeatedly went against medical advice.
Let me save you some time and money - and this “roadmap” won’t cost you anything. I’m giving it all to you for free. (I know. So generous.)
1. There is no cure for diabetes. Type 1? No cure. Type 2? No cure.
Yes, if you are Type 2, you can live well without medication if your diabetes is well-controlled. There is no shame in having to take oral medication or insulin; your body may just not make enough insulin or not utilize it properly. Anyone who says to you: “Oh, you have to take insulin? You must have it bad, ” deserves to be heartily ignored or given a raspberry by an orangutan.
We’re clear on that now? No cure. Repeat after me. No cure. Yes, it’s not a happy mantra, but it’s a real one.
2. This is not the Wild West. You don’t have to be a maverick.
Don’t go it alone. Don’t go “against medical advice” repeatedly. It’s perfectly OK to use the Internet for research into new treatments and management protocols and it’s great to reach out and ask others to share their own experiences, but they are not your medical team. Find a medical team that you can trust and work with them. If you are an informed patient and believe that your medical team isn’t up-to-date on the latest techniques and protocols, either find a new medical team or share your scholarly articles with them and you can investigate together.
3. Here’s a short list of treatments that don’t work to “cure” your diabetes: exotic herbs and spices, embryonic stem cell treatments, colloidal silver, Brewer’s yeast, colonics, fasting, aloe vera juice, blubber from a walrus, and the ever popular cinnamon.
What treatments do work? Lifestyle changes (otherwise known as “diet”, which is a word I abhor), exercise, medication, monitoring, a continuous feedback loop between your medical team and you, tweaking (not twerking, ewww) your diabetes management when needed, and support (like the amazing DOC or online support sites or face-to-face groups and conferences).
There are so many individuals who are misinformed, mistaken, and in need to help. I’m appalled that there are those who see them as an opportunity to make a fast buck, preying on those who sadly believe that this snake oil will cure them.
Because when the dust settles, these digital snake oil salespeople will be gone - along with the money.
And the diabetes will remain, tied up to the water trough, waiting patiently.