Kathy White’s long-term battle with type 1 diabetes and uncontrolled blood sugar led her to undergo an islet cell transplant a few years ago. Since then, she has not only had a better quality of life but she has become an advocate of the procedure helping to create an online support group. She believes this experimental procedure offers people with type 1 diabetes hope as it works its way through clinical trials towards FDA approval--possibly in the next couple of years.

By: John Parkinson, Clinical Content Coordinator, DiabetesCare.net

Kathy White (pictured, left) was diagnosed with type 1 diabetes at 24. She faced a typical path many T1s’ go through: from being on no medicine in the beginning to eventually taking oral medications and finally graduating to insulin. During this entire time, she tried sticking to a regular daily routine that included a healthy diet and exercise and using an insulin pump.

However, even with the best intentions, and good doctors, White still had vast swings in her glucose readings, never knowing if she was going to end up with a hypoglycemic or hyperglycemic number on a daily basis. After several years of dealing with her blood sugars’ unpredictability, White began to grow tired and increasingly frustrated, just wanting a reprieve from her numbers. She also began thinking long-term about her health and how it would affect her relationship with her kids and possibly, future grandchildren.

It was this gradual thought process where she began to think about one hopeful possibility.

In 2000, she came across a magazine article talking about an experimental pancreas islet cell transplantation trial being done in Edmonton, Canada. With White’s professional background as a microbiologist, she had a good understanding of how the procedure worked theoretically and believed it could be beneficial to people like her. At the time, she thought it was only being done in Canada and the Ohio native had no idea it was actually being done in the U.S., as well--only hundreds of miles away in Minnesota. Being in the early Internet era, there was not a lot of information out there, so White tried to keep up with any magazine articles she could find on the subject, but put away the idea of being a possible transplant candidate herself.

In 2007, however, White`s fate changed. While reading online about the drug Symlin, which she had been taking, she came across the University of Minnesota’s Schulze Diabetes Institute and their work being done in islet cell transplantation. There was an online application to become a candidate for the surgery and White spontaneously filled it out. She went through the entire pre-screening and was found to be a viable candidate for the procedure. In July 2008 she had the islet transplant, and within two months, she became insulin-independent.   

This operation has helped White and a small select group of people in transforming a majority of them into insulin-independent patients post-op. In fact, according to Brian Flanagan, PhD, program director at Schulze--where White had her transplant performed--almost 70 percent of transplant recipients become insulin-independent for a period of time. This comes with a caveat too. Dr. Flanagan also says that fifty percent of these patients are no longer insulin-independent at the five year mark. While these patients have to take some insulin, it is typically not at the levels they were on before the surgery. Still, the other 50 percent remain insulin-independent, and according to Dr. Flanagan, some patients have now celebrated 10 and 11 years of insulin-independence.   

What is fascinating about islet cell transplantation is that it remains a very under-discussed therapy. It does not appear to be out in the public sphere being discussed as a promising treatment. Yes, it is still classified as experimental, as it is in phase III clinical trials in the U.S., and there remains two main obstacles, but offering a therapy that provides many patients an opportunity to become insulin-independent is a radical departure for type1s.

The two obstacles islet cell transplantation faces are: getting insurers and the Centers for Medicare and Medicaid Services (CMS) to recognize it as a standard of care therapy, and therefore making it a reimbursable procedure; and also trying to minimize or eliminate the use of immunosuppressive agents, post-op. Patients must take a daily regimen of these drugs for as long as they continue to be insulin-independent. 

Since her transplant, White has helped create the Pancreatic Islet Transplant Recipients Facebook page found here.

All anyone has to do is read peoples’ comments on the group’s Facebook page to understand the various stages and emotions they are displaying. There are those anxiously awaiting to have the transplant done; trepidation from those who have had the procedure but might be sick due to an unrelated illness or who are experiencing a difference in their glucose numbers and wondering if everything is ok; and on the other end of the spectrum, gratitude from people who have undergone the transplant and feel as if their lives have been changed for the better.

There is some hope this procedure will be approved as early as 2013 or 2014 along with reimbursement from insurers and CMS. With this promising treatment moving through clinical trials, DiabetesCare.net decided to speak with White about how the transplant has changed her life, including her day-to-day experience, and the hope it could give to others who might be struggling with their self-management.

DiabetesCare.net: Can you talk about what your life was like prior to the operation, and why you finally decided to have the procedure?

White: I did everything I could to keep myself in line. I did the right diet, exercised, and tried oral medications. When I became pregnant I went on insulin.

However, I struggled with my numbers.

It was tough; I wasn’t at my wit’s end, but I remember thinking, ‘ I would do anything to have a flatline on my blood sugar reading for just two hours to see what that was like and not the up and down all day I experienced.`

In the long term, I began thinking about my kids who don’t have kids yet, but I hope they do soon. I don’t want to be that grandparent that is sitting in the chair who is never in a good mood. And when you don’t feel good you could see yourself going down that line.

And my endocrinologist was frustrated with my case as much as I was. We both knew we were doing everything we could, and at one point during an appointment before the transplant, right as I was getting ready to leave he said, ‘I wish there was more I could do for you.’

That was a very compassionate thing for him to say, but it was very hard to hear. It was devastating, actually. This man who had been keeping me on the cutting edge of diabetes care for years had just basically told me there was nothing he could do.

DiabetesCare.net: What were the considerations for the procedure and what did you have to do preoperatively?

White: I spoke to someone from Schulze as a pre-interview and the person asked me some questions. She then sent me some paperwork for both me and every doctor that I had to fill out--to basically say that I’m healthy as well as say I was a compliant patient and that I tried to do everything possible, but it just wasn’t helping me enough.

I went up to Schulze in Minneapolis for a physical. They hooked me up to heart monitors; they did an ultrasound on my liver. They also performed kidney function tests and blood work to see if I could withstand anything that might happen. I was placed on the list and I waited for the call.

I thought this was a shot in the dark and I thought I could increase my chances by applying to three other medical centers for the transplant. I applied to two in Chicago and also the Mayo Clinic. Throughout this time, I was a lot more internet savvy and I was looking into it. I kept seeing Dr. Hering’s [Bernhard Hering, MD, director of the islet transplantation program, Schulze Diabetes Institute] name as one of the top doctors performing the procedure.

DiabetesCare.net: Can you describe what the procedure was like?

White: The surgery itself is very minor; the big part of the procedure is the immunosuppressive drugs. I was admitted on a Saturday and I had the transplant on Monday. When I got there on Saturday, they immediately hooked me up to insulin and glucose so they would have my blood sugar ready. They also had to put a peripherally inserted central catheter line into my heart, which was a little daunting at first. The line was used to administer the immunosuppressive drugs more effectively.

These drugs make you very tired as they are suppressing your immune system, so it doesn’t attack the islets. That part makes you pretty sick. I remember the nurse describing it as having the worst flu. I didn’t think it was that bad, but I did have a fever and chills.

I had been through C-sections, and so I wanted to witness this, so on the day of the surgery, I had requested to be on the lowest dose of pain medication, but I still slept through the whole thing.

I did have some trouble with nausea for the next couple of days because of the medication. The incision itself is maybe two inches long and it is above my belly button. The pain was minimal, and the incision healed up fine.

While I didn’t see it, I understand they set up a catheter and the islets are delivered into the portal vein and then they proceed into the liver. 

DiabetesCare.net: What is your regimen of immunosuppressive agents you take?

White: I have been on three different regimens. The islet cell transplant segment I am in is called the Raptiva trial. I began on Raptiva (efalizumab) and Rapamune (sirolimus). My Raptiva regimen was nice; it was a once a week injection. I started off with the Raptiva, then I began taking sirolimus which is taken in a pill form and I took six pills once a day.

Unfortunately, six months into this, Raptiva was taken off the market. They then switched my whole regimen, and I went on Prograf (tacrolimus) and Cellcept (mycophenolate mofetil). I was on those two drugs for about a year. I couldn’t tolerate the Cellcept.

Since then, I have been on Rapamune and Prograf. My blood sugars have gone upward a bit and I have had to take some insulin but it is a lower dose than before the surgery.

DiabetesCare.net: How would you characterize what the procedure has done for you?

White: It is like having a burden lifted from you. I have so much more energy, and my whole body feels healthy. As far as the day-to-day things, I can do anything I want without having to worrying about low blood sugars. I don’t have to stop what I’m doing, whether out for a walk or at work, because my blood sugar is low.

For the transplant study I’m was in, I tested my blood sugar six to seven times a day. I still do it four or five times a day as I need to guide myself through this. My endocrinologist wants me to get a continuous glucose monitor so that I can know if I ever go high. He believes it is very bad for my islets.

As far as my diet, I do keep my carbs to a minimum. I do watch what I eat just because I felt my implanted islets are not as strong as someone who is not diabetic. I do want to appreciate my islets and want them to last as long as possible.

I still walk and do exercise every single day too.

DiabetesCare.net: In thinking about people with diabetes who exercise, do you still measure your glucose around exercise?

White: As far as exercise now, it really does make a difference. Before the transplant, I had such wild swings I couldn’t get a gauge on exercise. The phase I’m at now is something I longed for. I am successful at self-treatment now.
If I’m supposed to take a unit of insulin to cover a meal, I do and it works. Now, if I eat a big meal and exercise, I can forgo the one unit of insulin and the exercise does that for me.

DiabetesCare.net: What would you tell other people who are reading about an islet transplant and considering it for themselves?

White: Timing is everything. The first thing is your age. If you are in your mid-20s, look at the research right now; there are so many projects that are improving this procedure. I would say, ‘wait and see what the next version is going to be.’ Even if you a little bit older than that, you want to wait as long as you can. Then again, do not wait too long because you have to be healthy enough to pass all the tests and be healthy enough to be on the immunosuppressives.

However, I would recommend it to anyone whose blood sugar is out of control, and if the person is losing hope. I believe hope is a big indicator. It really helps physically and emotionally to see the other side of life with the transplant, even if it is temporary. I really think my organs are thanking me for this long break of not having the high blood sugars coursing through me. As one of my islet cell friends has said, ‘everyone worries about the immunosuppressants, but if have uncontrolled blood sugar, and you don’t have this option, you might be on immunosuppresants for a kidney transplant.’ 

You never know the path not taken, but I think I might have been on that course for a kidney transplant. It was my worst nightmare to think that I might have to go on dialysis.

As far as the immunosuppresants, there are short term and long term side effects. The short term effects include mouth sores and diarrhea, and of course they are both treatable and temporary. I have had no side effects for over a year. However, there is the long-term concern of kidney issues, which is something you have to think about.

For example, my kidney’s creatinine numbers are starting to drift upward. Both my endocrinologist and the Schulze physicians are worried about that. They urged me to see a nephrologist--which I did. If it became really bad, I would have to decide if I want to risk my kidneys while on the immunosuppressives or do I want to go back to where I was before. Neither is a pleasant thought at all. There is also a higher risk of cancer.

I’m only three years into it, and I do know people who are farther along than I and they don’t have any complications.

DiabetesCare.net: Why did you decide to create the Pancreatic Islet Cell Transplant Recipients Group on Facebook and can you describe who the group is made up of?

White: I wish I could take credit for forming the group, but I have to give credit to Matt Jay and he is somebody who found me through my blog. We had a conversation and next thing you know he created this Facebook page, with just the two of us on it. However, everyone who had contacted me from the blog, I saved their e-mail addresses. I then began e-mailing invitations for them to join.

It is a wonderful asset because there are so few of us. We are going through a monumental experience and because of HIPPA the nurses and doctors cannot help us find each other. It was really hard not to have anybody to talk to. Now we have over 150 members and there are about 15 to 20 transplant recipients on there. Some are on the waiting list, others are parents who are watching it for their children, and some are those just considering it.

We are a positive and happy group, but we are very frank about what we are going through. We joke that there must be something implanted with the islets that makes us want to share information with one another. We can get together with our worries, but we feel we have received this amazing gift and we want to share it with other people.

In next week`s Up Close, DiabetesCare.net is going to feature an interview with Schulze`s Dr. Flanagan who will delve deeper into the medical aspects of islet cell transplantation and the future of the procedure.