Research In The News (May)

This blog posting covers a couple of different topics, but starting with a piece of bad news:

Perle Biosciences Ends A Phase-II Trial of a Combination Cure

In November 2015 I blogged on a clinical trial by Perle Biosciences testing a combination of Cyclosporine and Omeprazole.  You can read the details here:
http://cureresearch4type1diabetes.blogspot.com/2015/11/perle-biosciences-starts-phase-ii-trial.html
Unfortunately,  that trial was listed as "Prematurely Ended", but I'm not sure exactly when.  There hasn't been an official press release on the trial, but JDCA quoted Perle Biosciences's president as saying the trial was stopped because "Enrollment was disappointing in Europe and we are planning to move all studies to the U.S."

Of course, I'm hopeful that they do start a trial in the US, and soon.  They are working with a combination of drugs: one of which stops the autoimmune attack and the other regrows beta cells. Both are already approved in the US (one is over the counter).  So you can see why this is an exciting treatment.

Unfortunately, this is not the first time Perle has had problems starting a study.  Prior to starting this European study, Perle filed paperwork to start two studies in the US.  This paperwork languished for over two years and the American studies never did start.   A parallel effort in Europe did led to this study, which has now been ended.

JDCA Coverage: http://thejdca.org/practical-cure-project-update-perle-bioscience-drug-combination-human-trial-ends-prematurely

Not In Human Trials: Stem Cells From Self

Researchers were able to create beta cells from stem cells, the stem cells having been created from skin cells of people with type-1 diabetes.  This might be important for a couple of reasons.  First, these cells could be used to test new drugs.  Many people have noticed (especially in the world of type-1 diabetes) that treatments which work on mice often don't work on people.  This is a way to test treatments on beta cells similar to a type-1 diabetic's actual beta cells.  Second, these cells could be used in transplants.  But remember, that only solves half the transplant problem.  Transplanted beta cells have two problems: the body's good immune system is trying to kill them because they are foreign and the body's bad immune system is trying to kill them because they are beta cells.  Since these cells are from the patient's own body, they will not have the first problem, but might still have the second problem.

To the best of my memory, previous reports of making beta cells from stem cells always involved the use of 3rd party stem cells (ie. the stem cells did not originate from the person who would eventually get the beta cells).  So this is a step forward in that regard.

This is animal research only right now, but could get into human trials in 3-5 years, which would then take an additional 10-15 years to become generally available.  That is, assuming it is successful.

Press Release: https://www.sciencedaily.com/releases/2016/05/160510132809.htm
Paper: http://www.nature.com/ncomms/2016/160510/ncomms11463/full/ncomms11463.html


Stepping Back from Artificial Pancreas Coverage

I've decided to scale back my coverage of artificial pancreas research.  This is for two reasons:

1. Because limited functionality Artificial Pancreas devices are already available from Medtronic now in Europe (the 640G) and in the United States (the 530G), and because an all-but-meal Artificial Pancreas device (the 670G) is planned for release in both places in the next few years, there is a lot of "regular" news coverage on Artificial Pancreas developments.  I do not think I'm adding a lot of value to Artificial Pancreas research reporting.  To be blunt: DiabetesMine, diaTribe, ASweetLife, and similar web sites are doing such a good job publicising AP progress, I don't feel like I'm needed in that area.
2. Because there is so much progress being made, on so many different Artificial Pancreas fronts, the avalanche of information is overwhelming me.  I just can't keep up.

Obviously, these are both good reasons to stop coverage.  I'm absolutely confident that a full Artificial Pancreas will be available in the United States in a few years, and I'd rather spend my time following research that is less certain, and harder to interpret.

If you are desperately in need of an AP update, read these:

• http://www.healthline.com/diabetesmine/artificial-pancreas-what-you-should-know which includes one paragraph on each of 11 (!) different commercial companies working on APs.
• http://insulinnation.com/treatment/bigfoots-artificial-pancreas-could-hit-the-market-by-2018/ for an update on Bigfoot, specifically.
• http://www.wsj.com/articles/tech-savvy-families-use-home-built-diabetes-device-1462728637 "do it yourself" AP in the news.
• http://www.healio.com/endocrinology/pediatric-endocrinology/news/online/%7Bdca7dc70-73a6-471c-be8a-2d394d288308%7D/artificial-pancreas-more-effective-than-sensor-augmented-pump-in-young-children reports on AP vs. CGM+Pump trial for kids at summer camp.  AP wins.

My Internet World

I use Blogger, LinkedIn, Facebook, and Twitter, but I divide up my internet world like this: The blog is very specifically focused on clinical trials aimed at curing type-1 diabetes. If that is what you care about, then either follow the blog or sign up for mail notifications when a new entry is posted. (There is a field in the upper right hand corner of the blog for that.)  My twitter covers type-1 diabetes more broadly and also some non-diabetes issues which are important to me.  It is more than half type-1 and less than half other issues.   I try to keep LinkedIn very strictly for work related stuff, and Facebook for family and friends.  So if you are linked with me either on LinkedIn or Facebook, but only care about diabetes news, then you'd probably do better to either sign up for emails from my blog or link with me on Twitter.

Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
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.

Artificial Pancreas Update (May 2015)

I have decided, for 2015 at least, to do quarterly updates for Artificial Pancreas research. The area is moving forward so quickly that I think that quarterly updates are warranted.

The term "artificial pancreas" refers to using a continuous glucose monitor (CGM) to feed data to a computer, which controls an insulin pump, and in some models, a glucagon pump as well. Artificial pancreas refers to using existing technology in all these areas, but connecting them together so that a person does not need to worry about counting carbs or blood glucose levels. It is all done automatically. Most people do not consider this a cure, but I follow AP research because some people do consider it a cure.  There is no doubt that such technology would be a huge step forward in treatment, and would largely prevent "dead in bed" due to low blood glucose events.

An earlier version of this blog had the wrong dates for future Medtronic product releases.  I'm sorry about that.  This posting has the correct dates.  Thanks to Tamar Sofer-Geri for finding the mistake.

Artificial Pancreas Update for April 2015

The JDRF uses a 6 step model to describe milestones on the way to the fully featured artificial pancreas that we all want.  You can read about those milestones here: http://jdrf.org/research/treat/artificial-pancreas-project/.
So when I refer to "step 1" and "step 4" and so on in this blog, I'm referring to the steps described by JDRF.

Corporate News from Medtronic

Back in January, Medtronic made the following product announcements:

• The 640G (predictive low glucose suspend) will ship in Europe in April 2015.
• The 640G will ship in the United States in April 2016.
• The 670G will ship in the United States in April 2017.
• The 670G will ship in Europe in April 2018.

News (from Close Concerns / diaTribe): https://www.closeconcerns.com/knowledgebase/r/ce9abf26

There are three pieces of good news included in those predictions.

First, the 640G is a step 2 Artificial Pancreas, so it will predict and avoid low blood glucose events.

Second, the 670G (depending on exactly how it turns out) could be a step 3 or 4 device.  That means it will predict and avoid both low BGs and high BGs, but not cover meals automatically.

Third, it means that Medtronics believes that the FDA's previous approval delays will stop:

• There was a 2.5 year delay (from European approval to US approval) for the 530G.
• Medtronics expects a 1 year delay for the 640G.
• Medtronics expects a 1 year advantage (US before Europe) for the 670G.

I hope they are right about this!  FDA's delays in earlier AP approvals are one of the major reasons AP development has been slow, and European availability is ahead of us. If the FDA is able to fix this problem over the next few years, that is a huge piece of good news for all AP companies and ultimately, all AP users.

MD-Logic Goes Commercial

MD-Logic is one of the artificial pancreas projects which has been in phase-II clinical trials.  I previously blogged on it in Nov-2014: http://cureresearch4type1diabetes.blogspot.com/2014/11/artificial-pancreas-update.html

In the past, it has been a research project, but a company called DreaMed Diabetes was founded to commercialize it, and they recently signed an agreement with Medtronic.  According to diaTribe:
http://diatribe.org/medtronic-signs-exclusive-agreement-use-glucositter-artificial-pancreas-software-future-insulin
Medtronic plans to use this technology in their artificial pancreases after the 670G.  The 670G will be a step 4 AP (automatic except for meals), while the MD-Logic based follow on will be a step 5 AP (automatic including meals).

Also, MD-Logic's blood glucose control algorithm got a "CE" mark in Europe (which is their "approval to sell" symbol).  You can read about it here:
http://www.diabetesincontrol.com/articles/diabetes-news/17774-artificial-pancreas-software-algorithm-receives-approval-in-europe-
However, I'm not sure what that means from a practical point of view.  You cannot use an algorithm by itself.  It has to be part of a piece of software or hardware, and right now no one is selling any product which uses the algorithm.  Maybe this CE mark will speed Medtronic's approval in Europe when the time comes?

Artificial Pancreas News From Tandem (makers of t:slim)

I slogged through a Tandem analyst's call in Feburary, which you can read here:
http://seekingalpha.com/article/2946926-tandems-tndm-ceo-kim-blickenstaff-on-q4-2014-results-earnings-call-transcript?part=single

There are only a few paragraphs on AP research, and my rough translation of them is this:

Tandem is currently experimenting internally, and not on people, with both predictive low glucose suspend (step 2 AP) and predictive high glucose dosing (step 3 AP).  In the second half of 2015 they will start the paperwork to run a clinical trial testing predictive low glucose suspend.  Based on discussions with the FDA at that time, they will have  better idea of how many clinical trials will be required for approval (and therefore how long it will take).  Also they will have a better idea about testing both the predictive low suspend and high dosing at the same time, or release one and then the other.

Bihormonal AP Update from CarbDM's Diabetes Summit

I attended CarbDM's "Diabetes Summit" in Silicon Valley last month.  It was wonderful, even though I could not stay to the end.  Listening to the morning speakers was very informative, but in this blog I'm going to limit myself to discussing  Dr. Ed Damiano's talk.

Dr. Damiano is working on a bihormonal (insulin and glucagon) AP, called the "Bionic Pancreas". The key piece of information from his talk was that they will finish the current round of phase-II trials on April 27th (that's the last day of data collection).   Another round of studies is planned for the second half of 2015.  For next year, the plan is to create a device that can be sold and spend the rest of 2016 and 2017 testing it.

Dr Damiano reported on results from several clinical trials (adults and children who use the AP under different circumstances).  For all these studies, the numbers were great (in my opinion).  They averaged in the low 140s or high 130s in different trials.

There were some other interesting tidbits: the daily dose of glucagon used by people on this bihormonal AP was between 1% and 3% of the dose used in a single "rescue" injection, so a relatively small amount.   Also, the amount of insulin used by people on the AP was about the same as people in the control group.  So it's clear that the bihormonal AP is using insulin more efficiently, not just using more insulin.

CarbDM's: http://carbdm.org/
The Diabetes Summit: http://carbdm.org/summit/

International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2015) 

This was a conference held in Feburary in Europe that had dozens of papers, many of which covered artificial pancreas research, continuous glucose monitoring techniques, and related areas.

You can see all of their posters here:
http://dasterminal.com/posters/attd2015/
Abstracts for a huge number of papers are here:
http://online.liebertpub.com/doi/full/10.1089/dia.2015.1525

Joshua Levy 
http://cureresearch4type1diabetes.blogspot.com 
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.