Joy Pape is a board certified diabetes nurse educator. She’s well known as much for her bubbly personality as for her years of experience working with PWDs in both inpatient and outpatient settings. She’s recently made a career leap that she’s very excited about. And you might be too, to hear her describe it…
A Guest Post by Joy Pape, CDE
This has been an exciting year for me. I’ve made somewhat of a career change. I, like many diabetes educators, used to mainly work with people with type 2 diabetes. Oh sure, I’ve been a pump trainer for years, but other than that, I still mainly worked with people with type 2.
I can honestly say, for the most part I’ve made the switch, I see more people with type 1 now, and I understand why people with type 1 diabetes feel so left out. On the other hand, there’s a lot more going on with type 1 than I was aware of.
The switch didn’t happen overnight. I’ve been a diabetes educator for over thirty years. About 15 years ago, I got involved with the hot topic of lower carb meal plans. Through that I got involved in media. I met a lot of people with type 1, many were writers, producers, actors, etc. I moved to New York City to further my work.
I now work with a Manhattan endocrinologist who sees a lot of people with type 1, and became a continuous glucose monitor (CGM) trainer. I see what people go through more and more. And I understand it’s a lot! Someone once told me, “Having type 1 diabetes is a condition of inconvenience.” How true!
Last summer I realized research was the way to go. So I learned about, and starting working with Tolerx. Tolerx is a world leader in understanding the function of T cells and developing novel therapies that treat autoimmune diseases, diabetes, and cancer by specifically modulating T cell activity. I know that’s a mouthful, but, I thought – “Auto-immunity and diabetes, how interesting! And how cutting edge!”
At the time Tolerx was conducting a phase 3 study (That’s right, a study in people! It’s way beyond the mice stage), called DEFEND. That has now come to a close, with very promising preliminary results. Now DEFEND2, the second phase 3 study has launched and is accepting people newly diagnosed with type 1 diabetes, 12 to 45 years old.
NOTE: Amy talked about Tolerx and DEFEND2 in her blog post, Tolerx: Attacking the Cause of Type 1 Diabetes in People (Not Mice).
This study is looking at preserving beta cell function and protecting the beta cell from further damage with the use of an anti-CD3 antibody, otelixizumab, pronounced o-tel-ix-iz-u-mab. “CD3” is the scientific name for a protein target on the outside of two types of T cells (lymphocytes) that are found in your blood. One type of T cell (killer cell) causes destruction of your insulin producing cells. The other type of T cell (regulatory cell) prevents this destruction by controlling the T killer cells. By using antibodies that stick to CD3, two kinds of useful actions may occur to help correct the type 1 diabetes. One action stops T killer cells and the other promotes the T regulatory cells that inhibit the T killer cells.
Early results have shown that this kind of treatment may result in better control of sugar levels with the use of less insulin. They have also been shown to lessen severe swings of low and high blood sugar levels. Wouldn’t this be great?!
In time we’ll know if this means fewer complications from T1DM and if this improves quality of life.
This whole field is interesting to me, because there’s not only the potential to help people with type 1, but we’re finding so much more about how the immune system is related to so many conditions, such as rheumatoid arthritis, psoriasis, thyroid problems, multiple sclerosis, and celiac disease. I’ve even heard Dr. Jay Skyler say that in clinical studies, even though the treatment was for people with type 1, those who had other auto-immune problems got better too.
One more thing about people with type 1: Through the years, I’ve noticed something else I think is interesting – I’ve met quite a few very creative and brilliant people who have type 1. I’m not saying that there aren’t smart people who don’t have type 1, and I’m not saying that every one who has type 1 diabetes is brilliant, but there seems to be a lot who are… way beyond the norm. Sometimes I’ve wondered if it has to do with what you’ve had to do since a kid. On the other hand, not every one of you brilliant ones has had diabetes as a kid. For now I’ll watch and wait to see if any emerging science comes from this.
EnJOY!
— Joy Pape, RN, CDE
Thanks Joy. We’ll take the compliment, and throw it back at you: we’re glad to have smart folks like you working on our case 
I often wondered for those adults who get type 1 later in life if there are more Type A personalities who get this diagnosis. Really busy productive folks who maybe put their health after all the other stuff they do until getting type 1 disease.
I’m always glad to read about studies that address the autoimmune process gone haywire that causes the destruction of the beta cells, and even more excited when they have shown promise in human trials. And LOL on the T1 brilliant folks! More and more it seems like the brainpower I devoted to diabetes distracts me from remembering things like where I left my coffee cup. Or maybe that is just middle age:).
I am curious why the Defend study excludes people over the age of 45 with new onset Type 1 diabetes. That seems to leave out a significant portion of the Type 1 population. Just as an example, former Assistant Surgeon General of the United States, Dr. Kenneth Moritsugu, who was diagnosed at age 49, would have been excluded from this study.
Congratulations, Joy, on your new career/adventure!
I love this guest post! Thanks Amy and thanks Joy!
Maybe I am biased, but I too think there’s something special about so many that live with type 1 diabetes.
I also wonder why those diagnosed with Type 1 after the age of 45 are excluded from studies. I was diagnosed 2 years ago at 49. I was very willing to participate in research, but no studies were available to newly diagnosed people my age.’
Kim
The Lost Arts Of War…
…an interestin post over at . . ….
Glad some of you found the post interesting. Here’s why the cut off point for DEFEND-2 was 45 years old… Both Tolerx and the FDA were concerned about enrolling people who had Late-Onset Autoimmune Diabetes of Adulthood (LADA) http://www.diabetesmine.com/2010/03/clarifying-lada-type-1-diabetes-in-adults.html,or a mix of type 1 and type 2. People who are older when diagnosed with LADA have a greater likelihood of also having insulin resistance. The presence of insulin resistance would skew the outcome of the study agent, otelixizumab (OTE). If OTE is efficacious, there is much additional trial work to be done, e.g., in people with LADA, as prevention, etc. Stay tuned, and do keep the DEFEND-2 trial in mind for people you come in contact who are 12-45 years old, and newly diagnosed with type 1. If you need more information, please do contact me.
Okay all you brilliant people who read diabetesmine.com, keep learning.
EnJOY!
Joy
Sorry for the typo…this is the correct link to LADA
http://www.diabetesmine.com/2010/03/clarifying-lada-type-1-diabetes-in-adults.html
Thanks again,
EnJOY!
Joy
Thank you for the explanation of the exclusion of new Type 1s over the age of 45. I was 49 at diagnosis. I do not have LADA, nor do I have insulin resistance. I have Type 1. Is this really that unusual? I have discussed this many times with my endocrinologist, who also has Type1. He is convinced I do not have LADA. I do not fit the pattern of LADA. The media seems to perpetuate the “myth” that all adults diagnosed with autoimmune diabetes have LADA. Is straight Type 1 in adults no longer recognized?
Kim
Kim, yes, it’s still recognized. It’s just that in the population over 45 there are many who do have LADA, and who do have insulin resistance. In clinical studies, it’s important to keep a study “as clean as possible”, so there are certain criteria to do so. For example, DEFEND2 also has criteria that adults’ BMI must be <32. Weighing more could be related to insulin resistance.
I hope this helps.
Thanks again and EnJOY!
Joy
This study sounds very interesting and promising for improving the life of Type 1 diabetics even though it is not a cure. I would like to make this option available to patients. How can I get patient materials? Also, when we see some results from this trial? Thanks
Hi all,
We received some discouraging news today about the DEFEND 1 Study.
Tolerx, Inc. and GlaxoSmithKline (GSK) today announced that the Phase 3 DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes.
The good news is that there were no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study.
So what does this mean for DEFEND-2?
GSK will continue to explore additional dosing regimens to inform decisions about the future clinical development programme for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongoing confirmatory Phase 3 study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.
Read more at:
Tolerx and GlaxoSmithKline Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint
I’ll let you know more when I know.
So, for now we continue to search for a cure and better treatments…
Thank you for all your support.
EnJOY!
Joy