Islet Cell Transplant study completed - the good news/bad news

As I mentioned in my previous post, the islet cell transplant study that has been ongoing for several years has been completed.  The centers who make up the Clinical Islet Transplant Consortium have transplanted the needed 48 patients and now the study is closed.  That is certainly the good news.  It is a great coup for all the scientists and staff who have worked so hard to get this accomplished.  The data will be collected and submitted to the FDA for approval.  WHEN this occurs, islet cell transplants will become standard treatment for diabetics who can benefit from this type of intervention.  Of course, insurance coverage will be another battle, but thats a separate topic.  The estimated date is 2013, which is just amazing.  I'm going to look into the possibility of pelting the FDA with success stories from the islet cell transplant patients that I have met.  I don't think I would have to twist any arms to get them.  We're a very happy group.

So, how could there be any bad side to this?  Its the human element.  The patients who have invested their time, money, and most importantly their hopes in the process of qualifying for an islet cell transplant, only to get a call saying that the program is over/closed.  There are several on the Pancreatic Islet Cell Recipients facebook page.  My heart really goes out to them.  I would have been devastated to have received one of those calls after I had been waiting for THE call.  I know this is an unavoidable situation in the process, but I need to recognize it.  Its really hit me hard.

the Senator at 10 months

It sounds like there might be some hope for getting a transplant before they are made available to the public.  During the Transplant Symposium, Dr. Hering mentioned that through a program called "expanded access", patients with more extreme need, may be able to receive a transplant.   The webcast from the Transplant Symposium is available now and here is the link.  He talks about the process of the trial, submission to the FDA, and this expanded access possibility at about 1:18min. into the program.  Its very heartwarming to see him smile when the applause erupts about the possibilities he has created

I also asked what the patients at the SDI are being told when they get the calls as to what they can do.  It seems that the clinical trials.gov  site is a good place to search for any current islet cell transplant trials.  At the SDI, they are not enrolling for current transplant studies, but will hold a patient's information for use in any future trials.  Also, they are still performing islet cell after kidney transplants.The webcast, like the Symposium itself is very interesting and fun to watch.  I noticed a few things that I had missed the first time.  It is a very upbeat and informative session.  I still have yet to read anything on line as to the completion of the transplant trials.  I'm disappointed in my google alerts and in the lack of any press of this monumental achievement.

Diabetes Symposium experience

The recipients and a diabetes alert dog

The Diabetes Symposium was held in Minneapolis on Tuesday evening.  It was an exciting and emotional experience for me.  I'm still waiting for the video of the session to be released, and will post it when it becomes available.  The Minnesota Medical Foundation has a link to Fox News and parts of the program here.

I arrived in Minneapolis on Tuesday afternoon.  My friend, Camille, picked my up at the airport and I stayed with her while I was there.  Spending time with her and her husband Geoff, was a very nice part of my trip.

The Symposium was held at the Best Buy headquarters. A local Fox reporter who is a Type 1 diabetic was the MC.  Richard Schulze is the founder of Best Buy and a huge supporter of diabetes research.  The Schulze Diabetes Institute is named for him.  It was an impressive building (lots of blue).  Just as we arrived, Janet, my retired nurse coordinator walked in.  I was able to sit with her and chat before the program began which was an added bonus.  There were about 450 people who attended the event and it had to spill over into an auxiliary room.

There were a few surprises in store for me.  Inside the folder that we were given as we walked in was the story that the Diabetes Research and Wellness Foundation did about my transplant as well as the nice picture of Dr. Hering and me.  I was just getting over that surprise when the program began.  It started with the video of the interview that Dr. Hering and I did in Washington DC at the previous Diabetes Summit.  That was a shock to see in larger than life form as well!

The format of the program was for the eight recipients to tell of their experiences with diabetes both before and after the transplant.  Its getting very difficult for me to hear those before stories.  It brings back so many uncomfortable memories of my seemingly previous life.  In addition, there were questions that people had submitted  on line as well as some live questions for the patients and Dr. Hering.

One of the highlights of the evening for me was when Dr Hering answered a question about when islet cell transplants might be available for everyone.  He began to tell of how the main transplant study was just completed last week which involved the centers in the Clinical Islet Transplant Consortium.   They had transplanted the targeted number of recipients and that the trial was closed except for collecting the data from the more recent transplant recipients.  In a year, when all the data is completed, it will be submitted to the FDA for approval.  If/When the FDA approves it, it will become available.  He projected that as happening in 2013.  I'm not sure how the insurance coverage will work with that.  I'm guessing that that will be another battle.  But, it is a giant step in the right direction.

Another issue that Dr. Hering spoke of is the fact that so many people see the immunosuppression as a deal breaker in having an islet cell transplant.  He gave his views on this which are that he doesn't feel that this should be the case.  The immunosuppression isn't perfect, but it is less problematic than uncontrolled diabetes.  I hope that many people will hear this message.  Its the most common question I hear or read about the procedure.

The recipients ranged from about 6 months post-transplant to 10 years.  Most were insulin free.  Greg had his diabetes service dog with him which was very interesting to me.  He told of how the dog saved his life at least once by alerting him of a low.  Melissa stated how she never realized how sick she was until after the transplant when she was able to feel so good and healthy.  Most had stories that involved the paramedics and some had experienced seizures.  One of the questions that was answered by each person was whether they would do this again.  It was a unanimous "yes".  Another common thread was of the families' involvement with the disease.  Many had to rely on their children to understand the limitations of their parents and to have to physically help them at times.  Having lows at work and having to depend on the assistance of coworkers was something mentioned by several people.  All of them suffered with hypoglycemia unawareness.

All of the recipients and doctors

I had a different perspective for this Symposium as a member of the audience.  I couldn't help thinking about the people that I was sitting with and wondering what they must be feeling.  I worry that the parents of diabetics, like Camille, feel very sad when they hear how much better the daily lives are of the patients after the transplant.  It must seem so unfair to think that your child is suffering with this disease with no immediate relief available.  I think of the other adult Type 1s who can hear how wonderful it is to be free of the worry of having lows.  Its probably very difficult to even imagine and, as I remember, almost painful to hope for.  I know thats why everyone is here, but what is being offered here is not something they can physically take home with them.  I think it was probably hard to turn around and walk out the door leaving all of this behind.

I hope that hearing all of these stories was very rewarding to the doctors and staff of the SDI.  I don't think that they can hear often enough what an impact their work has on the lives of their patients.

I didn't attempt to summarize the stories of the recipients.  I will post the video when it becomes available so that people can hear for themselves.  They were all very moving.  I don't think there were many dry eyes in the place.

Diabetes Symposium in Minneapolis

The Diabetes Symposium is being held in Minneapolis this year.  It will be very similar to the Transplant Summit that was held in Bethesda last November.  There will be eight islet cell transplant recipients present to tell their stories.  Dr. Hering will speak about islet cell transplants and Dr. Firpo will speak about her stem cell research for diabetes.  It will again be a great place to learn more about what is happening in diabetes research research for the cure.  I'm looking forward to seeing all of the Minneapolis SDI friends that I have made in the last three years.  It will also be fun to meet some more recipients in person.  I'll write all about it afterwards.

On the homefront, I just heard back from the nurse at the Nephrologist's office.  She told me that my labs came back ok.  I have a small amount of protein in my urine and my sodium is slightly lower than normal, but everything else looks fine.  I'm scheduled to have a renal ultrasound on Monday and I will have some more lab tests run before my appt in November to compare with these.  So, I won't be worrying about this.

I picked up my new foster Assistance dog on Thursday.  His name is Senator and he seems like a very nice dog.  He looks a lot like Dolly which was hard at first, but now we're getting used to having a new dog.  He has a different personality than Dolly.  He's not so afraid of things and not so inclined to jump on people.  He does have his own set of issues however.  He can be a barker at times which is totally unacceptable for an Assistance dog.  He barks with a high pitch bark when he wants Callie to play or something from us.  That is acceptable for now.  However, he also barks at things outside with a lower pitched bark.  This is not acceptable.  We're working on this and he might be getting a bark collar which sprays citronella when he barks.  Its actually kind of interesting to have a new set of problems.  I get to learn a wider cross section of training.  Part of getting him to quit barking might involve training him to bark on command and then training him to stop.  Cool stuff.  I didn't realize how much I would enjoy the learning aspect of training a dog.  Its a science in itself.

The Senator and Callie are already buddies.  And Callie is still the boss.

JDRF Promise meeting

Angel, Lara, Lori, Me, Rep. Latta

I had a JDRF Promise to Remember Me meeting yesterday with my State Representative Bob Latta.  It was again a very pleasant and rewarding experience.  I was very pleased with his response to our stories.  He asked some very insightful questions and seemed truly interested in what we had to say.

I had three people with me for the meeting.  Lana spoke about her experience with having a daughter who is now 4, but was diagnosed with Type 1 at 2 years old.  Angel and her Mom, Lori told of her experiences growing up with diabetes.  She was diagnosed at age 3.

Lara spoke first and told of having to be available constantly to monitor her daughter Addison's blood sugars.  It was difficult to work or to get away with her husband or to get a good night's sleep.  She told about how she could tell when Addison was low because her activity level decreased dramatically.  It was an emotional story about a situation that seems so unfair on so many levels.

Angel is a college student and had organized her thoughts on paper.  She started reading from her notes about difficult aspects of her life with diabetes.  Rep. Latta interrupted her with questions that brought out some very interesting stories about how hard she would try to keep her blood sugars under control, but how impossible it seemed to be.  She talked about her dismay with her high A1c and tried to explain what that was and what the implications are of having it be too high.  She spoke about how hard she tried to lead a normal life, but how diabetes makes that difficult.  She also spoke of how hard it is to tell people about her diabetes.  As a college student, she can't rely so much on her parents and needs to rely more on roommates and friends.  That is difficult at her age when independence is everything.  Rep Latta asked her several questions throughout her talk and I'm not sure she ever made it back to her prepared speech.  But that, I think is a good thing in that it brought out some interesting situations.  She was very compelling as was Lara.

I knew we were running out of time.  We were supposed to hold our meeting to 15 to 20 minutes.  So I only mentioned that I used to be just like Addison and Angel.  Until my transplant.  Rep Latta was very interested in the transplant process and how the FDA would be involved in getting this approved for all diabetics.  We talked about the surgery and the results.  I explained how I had two years with no insulin, but that most people get at least 5 years.  That the research was indeed moving forward.  I mentioned the article about the cost-effectiveness of islet cell transplants vs. insulin therapy.   He told us that he is on a Healthcare committee and comes across questions like this.  He asked for some more information so that he can better understand it and be prepared to discuss this if it comes up.  This, of course, got me very excited to tell more about it.  I also promised to send more information to his office. He was also interested in the insulin pump and continuous glucose monitor.  I explained how they work, some of the mechanics, and how they are attached to the patient.

Between my interesting partners and Rep. Latta's involvement in our discussions, it was a very pleasant and successful meeting.

Gathering my thoughts

I seem to be right in the middle of so many projects right now.  Some diabetes related and some not.  Writing them down can be therapeutic and help me set and see some priorities.

ADVOCACY
I am trying to organize two Promise to Remember Me meetings with Ohio congressmen.
I was able to get a meeting date for my own local representative, Bob Latta.  It will be on Tuesday afternoon.  I have a college student and hopefully a younger child attending with me.  We will all tell our own diabetes stories and I will leave an information packet.

I'm also trying to get a Promise meeting with Speaker Boehner who is from the Dayton area.  After several calls and emails, I still don't have a meeting set.  I'll just have to be persistent.

I'm busy getting my JDRF walk organized.  The email system of communication is convenient, but too easy to ignore.  I think I have a day of making phone calls ahead of me in gathering my troops.  That's in 3 weeks.

I will be going back to  Minnesota! for a Transplant Symposium.  Dr. Hering told me about it at my visit last month.  I've been waiting to see it in print before I start preparing and buying a plane ticket.  I finally have seen a brochure, so am starting to think about what I want to say this time.  Needless to say, I am very excited.

HEALTH
I have my appointment with the nephrologist right after my meeting with Congressman Latta on Tuesday.  I am more curious than worried about this.  When my endo increased my dose of Lisinopril (BP medicine), the ankle swelling went away.  My biggest fear is being told that I now have to limit my protein intake.  I'm already limiting carbs and fats and am too thin.

Renae called on Thursday to tell me that my monthly lab draw showed that my level of Tacrolimus was very low.  We're hoping it is a fluke or lab error and I had it redrawn yesterday.

My BGs have been fluctuating more lately.  Since my last A1c and C-peptide results, my new strategy is to just increase my insulin.  Its frustrating, but works.  Yesterday was better, so hopefully I'm getting back to normal.  My sleeping habits have not been good lately, probably due to some of the above and below.  That can effect BGs.

Still working on getting a continuous glucose monitor.  I need to call my endo to see if he has submitted his letter yet.  I want to tell him about the Diabetes Symposium too.

GOODBYES

On Monday evening, Cassie left for California.  She and a friend made the trip across the country.  They arrived in Sacramento on Thursday where Cassie is in a friend's wedding.  They will leave there on Sunday to visit Gary in Santa Barbara and then make their way back to San diego.

Dolly was released from the Assistance Dog program.  She just couldn't get past her fear behaviors.  We had her for about 10 days until a family was found to adopt her.  We said goodbye to her on Thursday morning.  It was very emotional for all of us.  We really miss her.

I have decided that I want to try training another dog.  It was suggested that I try an older dog this time because I won't be having as much help at home now.

We have a nice weekend planned.  Nothing for today and a trip to Put in Bay with some friends tomorrow.  Sounds about perfect.