Wednesday, August 20, 2014

ADA 2014: Scientific Study Shows CarbDM Is Good For You!

As Dave Berry used to say "I'm not making this up!".  There was a study presented at ADA 2014 where the researchers offered college aged (18-25) people with type-1 diabetes a weekly "diabetes club" where they could interact with others who had type-1, ask questions, and hear 15 minute talks on topics of interest.   (Sound familiar?)  The people who attended these meetings lowered their A1c numbers by about 1.2, which was statistically significant compared to the people who did not attend.  As a general rule, the FDA considers drugs that lower A1c by 0.5 to be effective, so this result would be more than enough to get a drug approved, if this treatment had been a drug.

Here is their summary:
The mean HbA1c level was reduced at 3 months after the start of the program (from 8.8% to 7.6%), but even more pleasing was that also the long-term follow-up, after one year, confirmed the sustainability of the results (with mean HbA1c level 7.4%), ... The frequency of severe and mild hypoglycemia was also reduced
Obviously, in spite of the headline, this is not CarbDM specific. It shows the importance of peer support groups for type-1 diabetes.  I don't think anyone on Bravebuddies would doubt this, but it's good to see it supported in the scientific literature.

Source: Abstract 2312-PO

Although I focused on this one abstract, the concept of peer support, and different kinds of support groups, was a very popular one at ADA 2014.  Several of these studies focused on using on-line support groups of various kinds.  My memory is that there were 10+ abstracts on related topics, including one or two from Stanford University Hospital.

Joshua Levy 
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Tidepool 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.

Thursday, August 7, 2014

ADA 2014: Type-1 Research and Information

This posting covers things I learned at the 2014 ADA Scientific Sessions, about type-1 diabetes, that were not cure related.

Transplants for Type-1 Diabetes

There was a paper at the prestigious "President's Session" on the results of a large, recent phase-III trial of pancreatic transplantation.  These were "classic" transplants (these patients were on immune suppression for the rest of their lives) so this is not a cure by my definition.  However, the results were impressive:
  • 50% used no insulin 1 year after treatment.
  • The rest used very little insulin (average insulin usage at 1 year was less than 0.5 units / kg / day)
  • Even after one year, C-peptide production was improving, so it is likely that these results would continue for some time.  (These patients will be followed to confirm that.)
While I continue to think that long term, whole body immune suppression is too toxic to consider a cure, I know that some people consider this path, and I think if you are going to consider it, you should have the most up to date data.

Accuracy of Diabetes Alert Dogs (DADs)

I've always wondered how accurate diabetes alert dogs were.  Especially since they are trained by many different organizations all over the country, with very little standardization or regulation.  It turns out, I'm not the only person who wondered about it.  There was a research poster on this subject by Shepard (et al.) from Charlottesville, VA, USA.  They collected data from diaries kept by 18 diabetes dog owners.  All dogs came from the same (unnamed) organization.

Overall the hit rate (an accurate alert) was between 50% and 65% (combining hit rate for low BGs and high BGs).  There was a lot of variation.  For example, one dog had a 100% hit rate for detecting lows, but another dog had 33%.  The minimum-maximum for dog detection of highs ranged from about 30% to about 77%.

I remember there being more information on the poster (I'm writing this off the abstract of the poster), but we are not allowed to photograph the poster.  I hope these guys publish the whole report.  I suspect they have a lot more data to share.  Poster was 73-LB.

There was also a presentation (874-P) on Diabetic Alert Dogs in general.  Here were their main conclusions about the industry (quoted from the abstract).  I've added some of my own opinions in square brackets; kindly remember that I know nothing about training dogs.  The term SD means Standard Deviation, which is a measure of how "spread out" the data is; higher numbers are more spread out:
  • Roughly half of the groups surveyed were designated non-profit organizations while the remainder were for-profit. 
  • Length of time organizations had been training DADs ranged from 1 to 13 years, with a mean of 4.6 years (SD = 3.3). 
  • The number of trainers in groups varied, ranging from 1 to 8. Number of DADs currently in training ranged from 2 to 175 across groups. Number of DADs placed per year also varied greatly, ranging from 1 to more than 100. 
  • The cost for DADs ranged from $1,000 to $30,000 or more, with a mean of $12,429.00 (SD = $8,121.10). 
  • Some but not all non-profit organizations assist prospective DAD owners in fund-raising efforts to cover costs. [I think some of the for-profits do as well.]
  • Dog age at placement in homes ranged from 2 months to 2 years (mean age = 19.1 months, SD = 6.2).  [Isn't 2 months barely over weaning age?  How can a dog be trained so young?]
  • There appears to be consistency in DAD training procedures, with all but one group using saliva samples. [I don't think this represents much consistency, as they could be using saliva in completely different ways.  I don't think the exact body fluid used in training is particularly important compared to other variables in the training process.]
And I just saw this TV news article on problems with diabetic dogs:

Dulaglutide: Once a Week Insulin

Dulaglutide is a new insulin which is being tested in type-2 diabetics for once a week bolus use (as a replacement for daily doses of Lantus or Levemuir).  There were at least 9 abstracts on this.  I don't think any of them included type-1s, but several of them were phase-III trials (including hundreds of people), and at least one trial ran for a year.  That suggests to me that this insulin is not far away from approval.

Sources:  962-P, 964-P, 979-P, 980-P, 981-P, 962-P, 110-LB, 122-LB, 330-OR

There was another weekly insulin, called HM12470, which is being tested in animals, and was reported on in only one abstract: 89-LB.

Stem Cells

There were over 42 abstracts on stem cells.  They covered many different areas, including both animal and human research, and many different types of stem cells.  A lot of the abstracts reported on progress in creating stem cells.  I skimmed through the abstracts, but found nothing particularly interesting for people with type-1 diabetes.

If you had type-2 diabetes, the most interesting paper might have been 123-LB.  These researchers tested giving patients stem cells from their own bone marrow.  It was a phase-I pilot study, but included 61 people and was placebo controlled.  Results focused on safety, which was fine, but they did have some effectiveness data, and that was good as well: A1c dropped from 0.2 to 0.5 depending on time and dose.  That's a pretty small result, but not bad for a phase-I trial aimed more at safety than effectiveness.  My understanding is that the stem cell treatment they used was the oldest, best understood, safest, and easiest stem cell treatment around.  So if it does turn out to be effective, it will be relatively cheap and widely available.

Type-1 and Cancer

It is well known that people with type-2 have a higher chance of cancer than others, but what about people with type-1 diabetes?  If the higher cancer rate was caused by high BG numbers, then one would expect similar higher cancer rates in type-1s.  One poster reported on cancer rates on people with type-1 diabetes from four countries that have diabetes registries (Australia, Denmark, Finland, and Sweden).

Overall there was no statistically significant rise in cancer in type-1s as compared to the general population for men, and a really tiny effect in women. (The increased risk was 5%; for this kind of study, that is very small.)  I think type-1 diabetics should take a lot of comfort in this.   However, there were five cancers with significantly higher risk ratios in type-1s: colorectal cancer, liver cancer, pancreatic cancer, kidney cancer, and thyroid cancer.  I assume that there were also cancers that type-1s had a lower incidence of (as compared to the general population), so that the overall cancer rate was about the same.  But the researchers did not specifically list those.

This was poster 174-LB.

New Encapsulation Technology

A group in Italy has developed a new encapsulation technology, which is constructed layer by layer. They reported on the physical parameters of the new coating and success in mice.  It looked interesting to me.  I asked specifically about comparing the physical properties of this coating to the physical properties of LCT's coating or the IsletSheet coating, but they had not done any comparisons.  (They seemed to have a research mindset, rather than a competitive product mindset, which makes sense, since they are university researchers.)

Eye Targeted Transplantation

The immune system does not have access to the human eye in the same way it has access to other organs of the body.  This is called "immune privilege" and it means that things in the eye are not attacked as aggressively by the immune system.  For several years, the Diabetes Research Institute (DRI) has been exploring the idea of doing islet cell transplantation into the eye, so that the new cells would not be attacked by the immune system nor would they be attacked by the autoimmunity that triggers type-1 diabetes.  The researchers also liked the eye as a location for transplant, because it is easier to monitor.  If you put the cells near the pancreas (for example) you can't see them.  But if you put them in the eye, then you can just look in and see them.  So you can see if something is going wrong.

This presentation discussed progress in this area.  Unfortunately, it turns out that the eye is not completely free of immune response.  Early on there was the hope that the immune system was completely blocked from the eye, and transplanted cells would be ignored.  The immune attack in the eye is much lower than in other parts of the body, but it does still exist.  Studies have been done in mice and baboons.

I asked the obvious question: does it affect vision?  The answer is probably not, but more testing is definitely needed.  Mice don't see well, anyway, and tend to rely on hearing and smell, so it's not obvious if their sight is affected.  Baboons are much harder to work with, and these researchers did not systematically measure eyesight in either mice or baboons.

This was paper 437-OP and/or 348-OP.

SGLT2 targeted treatments

There were a couple of talks and a couple of posters on SGLT2 targeted treatments (mostly in the context of treating type-2 diabetes).  However, this research might lead to improved treatments for type-1 diabetes (although I doubt a cure).  This drug class works by causing kidneys to pee out more sugar, so it tends to lower post meal BG spikes.  This sounds helpful to me.  In addition, there was one paper (in the President's Session) that implied that SGLT2 was also involved in Glucose generation, such that the same SGLT2 drugs might also minimize lows.  If true, that would be doubly helpful: the same drug could lower the highest spikes and raise the lowest troughs of BG.

There was one session on SGLT2 specifically, and it had about 13 presentations, plus there were about 12 presentations on SGLT2 in other sessions in the conference.  That's a lot of coverage.

Joshua Levy 
publicjoshualevy at gmail dot com 
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Tidepool 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.