This is a combination of updates from the last month or two.
DILfrequency Completes Data Collection
In late may, the DILfrequency research team announced that they had finished collecting data, and were now starting to analyse that data. Of course, that's great news, because it implies that results will be published in the next year or two. (In my experience successful results are published within a year, unsuccessful results often take longer, if they are published at all.)
This study is testing Aldesleukin (also called Proleukin or IL-2) by giving it to adults within 5 years of diagnosis. IL-2 is a component of the immune system, and they hope that more it will either improve or cure type-1 diabetes. Are are looking for changes in the immune system which occurs quickly (ie. in a few weeks), or changes in insulin, A1c numbers, or C-peptide over a three month period.
I previously blogged on this study here:
These researchers seem to be months ahead of schedule. Previously, they expected to finish data collection by October 2016, but they have actually finished in May 2016, which is a testament to their ability to recruit people with type-1 diabetes. Even better, they enrolled more people than expected: 36 expected vs. 41 actual, that's 14% bigger than planned for. This group is very media-savvy, with lots of tweeting, facebook posting, a pinterest page, etc. I suspect that this media focus helped them recruit, and I hope it represents the future of clinical trial recruiting techniques.
New To Me: Cord Stem Cells In A Phase-II Clinical Trial
This trial started in 2009, but it registered with the US FDA's clinical trial registry in April 2016, and I did not know about it before then. The basic plan is to give a total of 30 people a transplant of 3rd party umbilical cord stem cells (called allogeneic umbilical cord mesenchymal stem cells). The people treated will be honeymooners (within 12 months of diagnosis), and must have had DKA when diagnosed. There is no control group; everyone will get the treatment. People will be followed for three years after transplant. Primary outcome will be insulin usage, and secondary outcomes will be C-peptide, A1c, and autoantibody counts. The researchers hope to finish collecting data in Dec 2019.
They are recruiting at one site:
Nanjing Drum Tower Hospital of Nanjing University Medical School. Nanjing, Jiangsu, China, 210008
Contact: Dalong Zhu, MD.PhD. 86-25-83106666 ext 61430 firstname.lastname@example.org
Contact: Jing Lu, PhD. 86-25-83106666 ext 61431 email@example.com
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT02763423
This research is similar to Haller's work at the University of Florida, which completed a phase-I and started a phase-II clinical trial also in 2009. I've blogged on that research here:
Unfortunately, the phase-II study (which included a control group) completed in 2012 and was published in 2013, but was unsuccessful. Exact quote was "Autologous UCB infusion followed by daily supplementation with vitamin D and DHA was safe but failed to preserve C-peptide.".
ATG Is Unsuccessful in a Phase-II Trial
58 people recently diagnosed with type-1 diabetes were given antithymocyte globulin (ATG) in the hopes that it would modulate the autoimmune attack on the pancreas's own beta cells. The primary end point was C-peptide generation after 2 years (a measure of the body's ability to generate it's own insulin). People who got the treatment did no better than people who did not.
Trial Registration: https://clinicaltrials.gov/show/NCT00515099
Although there was no improvement if the researchers looked at everyone in the study, if the researchers only looked at older patients (between 22 and 35 years old), then they did see a statistically significant improvement in C-peptide levels as compared to untreated patients of the same age. The researchers were hopeful that future testing might show that ATG is helpful for older patients.
Diabetes Care Has A Section On Artificial Pancreas Papers
You can read 9 AP papers in one place:
Diabetes Care is published by the ADA.
Losing Autoantibodies: Does It Happen And What Does It Mean?
It is now well established that people test positive for autoantibodies before they are diagnosed with type-1 diabetes, and (statistically) more autoantibodies are detected over time as people move closer to diagnosis. Also, there is a big difference between having one autoantibody and having more than one. I'm sometimes asked: can someone lose an autoantibody that they previously had? Put another way, are autoantibodies a one way progression to type-1 diabetes? Or can people move closer or farther away from diagnosis (at least as measured by number of autoantibodies).
The answer, according to this paper:
is "its complicated". Basically, some people do lose an autoantibody that they previously had and therefore, at least on paper, move away from type-1 diabetes. However, in real life, most of the people who lose an autoantibody only had one to start with, and therefore were unlikely to ever be diagnosed with type-1 diabetes. The people with more than one autoantibody (and who are likely to be diagnosed) rarely lose an autoantibody.
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.