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21th Annual Shooting Stars JDRF Walk to Cure Diabetes Sunday, October 23, 2016 in Newport Beach, CA at The Waffle House

For a contribution of $50 (or MORE!), walkers will receive a VERY COOL Shooting Stars Team T-Shirt while supplies last. Contact Joanne if you are interested in attending the event. joanne@TheSavvyDiabetic.com. To donate on-line, please go to: http://tinyurl.com/z5c2x8e.

Savvy Update 5.14.2017: Fiasp

Happy Mothers’ Day to all of you who are moms, aunts, grandmothers, people with moms, pet moms!  Here’s a special Mothers’ Day edition about Fiasp!

Novo Nordisk’s Ultra-Fast Rapid-Acting Insulin Fiasp Approved in Europe and Canada, announced on Nasdaq GlobeNewswire, 10 January 2017.  Why am I just writing about this today?  Well, it’s available in Canada and reasonable prices … and coming to the US hopefully by end of 2017!  And from what I hear, it works very well!  Read the release: Fiasp® (fast-acting insulin aspart) approved in Europe
Here are some highlights by Mike Hoskins from DiabetesMine:

FIASP is not the most creative branding (sounds like a variety of wasps?), but the name certainly fits. Whether it will carry a new brand name here States when launched remains TBD.
Internationally, FIASP is available by vial, Penfill, and FlexTouch insulin pen. In Europe it’s approved for insulin pumps but not in Canada. Here in the U.S., Novo tells us FIASP will only be available in pen form.
While Novo officially still recommends taking FIASP before the meal, overall they’re touting more flexible dosing, mentioning “earlier, greater and faster absorption, thereby providing earlier insulin action.”
It’s twice as fast as regular NovoLog or NovoRapid. Getting into the science, that’s because two “excipients” have been added to FIASP’s formulation — Vitamin B3 (niacinamide) to increase the speed of absorption, and a naturally occurring Amino Acid (L-Arginine) for stability.
Data also show that patients lowered their A1C levels.

Read LOTS more including reviews from patients: The Scoop on Novo’s New Faster-Acting FIASP Insulin

Savvy Updates 3.27.2017: Immune Response, 2 Types of Beta Cells, Wearable CGMs, Health Apps, Twins

children and twins concept – two identical twin girls in red dresses looking somewhere

As always, lots of news in the T1d community.  Here goes!

Preventing the Immune Response to Implanted Diabetes Devices was reported by Jessica Apple on ASweetLife.org last week. 
JDRF announced a report of one of the first studies to deeply examine the fundamentals of how the immune system interacts with implantable biomaterials. The study was conducted by researchers at MIT and Boston Children’s Hospital and was reported in the journal Nature Materials.
According to JDRF’s press release, tens of millions of people in the United States are living with implanted biomedical devices or devices that penetrate the skin. “By understanding how to target and prevent unnecessary immune responses to the materials used in medical devices, we can provide therapies that work more effectively and with fewer negative side effects,” said Aaron Kowalski, Ph.D., JDRF Chief Mission Officer. The new report, “Colony stimulating factor-1 receptor is a central component of the foreign body response to biomaterial implants in rodents and non-human primates,” could influence the future ability to prevent immune rejection of devices that treat type 1 diabetes.
Read more:
Preventing the Immune Response to Implanted Diabetes Devices
New Research Identifies Novel Target for Controlling Immune Response to Implanted Materials
Colony stimulating factor-1 receptor is a central component of the foreign body response to biomaterial implants in rodents and non-human primates
 
There are Two Types of Beta Cells and One Resists Immune System Attacks, according to a new study published in Cell Metabolism, 7 March 2017, which details a subpopulation of insulin-making beta cells that can resist immune system attacks while type 1 diabetes is developing.
In type 1 diabetes, the immune system attacks the insulin producing beta cells, which over time […]

Savvy Updates 3.12.17: Alexa, Live Stem Cell Imaging, New Cause of T1

Wow, some really neat stuff in the news!
Merck aims to put Amazon’s Alexa to work on voice-enabled diabetes tools, according to a post on FiercePharma.com by Beth Snyder Bulik, 8 March 2017 … thanks to Mike Hoskins for the heads up.
Using Amazon Lex, the brains behind the Amazon Echo device and its well-known voice-enabled assistant Alexa, Merck & Co, in a new partnership with Amazon Web Services, plans to initially work on diabetes. Its first initiative will be a call to entrepreneurs, techies and industry types for an innovation challenge expected to begin within the next month.
The yet-to-be-named challenge will be run by strategy and innovation consultancy Luminary Labs. While specifics haven’t been released, the call to action will “be open to solutions broadly enough that innovators of all stripes can come up with really novel ideas but being narrow enough to provide guidance and carefully evaluate submissions,” said Sara Holoubek, founder and CEO of Luminary Labs.
Read more: Merck aims to put Amazon’s Alexa to work on voice-enabled diabetes tools
 

Live stem cell imaging technique opens new windows into pancreatic regeneration, as posted on www.diabetes.co.uk, by Camille Bienvenu, 3 March 2017. 
Richard Tan, a PhD student from the Heart Research Institute, in Sydney, Australia, has developed so called “bioluminescent” (that emit a light signal in order to track their fate in real time once injected into the body) stem cells as a non-invasive way to give scientists immediate feedback on whether organ tissue regeneration is actually working.
In type 1 diabetes, stem cell-based therapies hold promise to regenerate cells of the pancreas. The goal is to have the stem cells transform into insulin-producing cells.
Read more: Live stem cell imaging technique opens new windows into pancreatic regeneration
Stem cells are […]

SAVVY UPDATES 1/9/2017: Lots of Tech News

Happy New Year and Welcome to 2017!  This promises to be an exciting diabetes year and we’re starting off with lots of updates!

 

 

The Biliary Tree of Life, as described by the researchers at the Diabetes Research Institute (DRI), is a network of stem cells in the biliary tree, liver and pancreas, being proposed as a framework for understanding liver and pancreas regeneration after extensive or chronic injuries.  These Stem cells will also be considered for the study and treatment of diseases that affect these organs, such as Type 1 diabetes.  Indeed, animal trial results suggest that cells outside of the pancreas can produce insulin.

Read more: The Biliary Tree of Life

 

 

Higher Insulin Doses May Require More Aggressive CV Attention, according to the findings from the Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada and the Newfoundland and Labrador Research and Development Corporation, 3 January 2017 and reported in The Lancet, January 2017. These studies conclude that higher insulin doses are associated with increased mortality.

Read more: Insulin dose and Mortality

 

 

 

 

Twenty-two New Patents Added to ViaCyte’s Intellectual Property Portfolio, reported by ViaCyte, Inc., 4 January 2017.  In early 2016 the Company announced the consolidation of the assets of the Janssen BetaLogics group into ViaCyte.  Five of the new patents originated in the BetaLogics group, while the other seventeen are from ViaCyte research and development activity.  Collectively, these composition, method, and design patents cover the full spectrum of ViaCyte’s activities, strengthen the already robust combined intellectual property position, and further ensure the success of the Company in its efforts to develop a functional cure for insulin-requiring diabetes.

Read more: Twenty-two New Patents Are Added To ViaCyte’s Intellectual Property Portfolio

 

 

K’Track Devices Monitor Glucose and Lactic Acid using […]

T1D Exchange and their First Annual Diabetes Innovation Challenge

This is exciting!

 

 

 

 

 

T1D Exchange and M2D2, a joint venture of the University of Massachusetts Lowell and Worcester campuses that incubates medical device start-ups,  have announced the first annual Diabetes Innovation Challenge (2016).

 

The Diabetes Innovation Challenge will provide up to two awards of up to $150,000 in cash or in-kind services provided by T1D Exchange, M2D2, and Challenge sponsors, including the American Diabetes Association and JDRF.

For this year’s innovation Challenge, nearly 60 innovators submitted their applications for consideration. T1D Exchange has narrowed the list down to 26 semi-finalists.

Now, semi-finalists will pitch their innovations in one of two competitions in front of a panel of esteemed judges (think Shark Tank) with the hopes of advancing to our finals event.

Who We Selected

Semi-finalists were chosen based on a few criteria, including what stage of development their innovation was (either early stage or translational) and whether their solution fit into one of our four innovation categories (a device, diagnostic, therapeutic or technology).

Here’s a quick look at just a few semi-finalists:

from Enable Biosciences, an ultrasensitive auto-antibody test to detect diabetes sooner than what’s possible today

from CamMed, a thin, flexible patch pump for one or multiple injectable medications

from Dibatech, a portable and re-chargeable device that can keep insulin stable at unfavorable temperatures in areas with erratic power supply (focused on third-world countries)

from Sproutel, a smart teddy bear teaching tool that helps young helps children gain hands-on skills in diabetes management (through play)

from Clinitech, an electronic band-aid for noninvasive glucose monitoring

What’s next?

T1D Exchange will host two semi-finals events in late September and early October. From there, finalists will be selected who will present their solutions in late October to another panel of esteemed judges. While award winners will receive […]

ADA 2016 Scientific Sessions ~ Artificial Pancreas, Finding a Cure, Better Cannulas

From the American Diabetes Association 2016 Scientific Sessions, held in New Orleans, June 2016.

Artificial Pancreas: Several new products in development show tremendous improvements in glycemic control and reductions in hypoglycemia … and they are not far off now.

Medtronic’s insulin-only hybrid closed-loop 670G system is the  furthest along … premarket approval submission to the FDA is expected this summer.

Close behind is the “bionic pancreas”, developed by Dr. Ed Damiano from Boston University.  A fully integrated dual-chamber device, called the iLet will come out by Beta Bionics, a public benefit corporation, working with Denmark-based Zealand Pharma.  One chamber will hold insulin, and the other chamber, with a separate infusion set, will hold a new stable glucagon analog.  The iLet single change device will reach the market first, due to the torturous regulatory path.

I had the opportunity to hear Dr. Damiano speak this month, to see the data charts of the amazing effectiveness of the dual chamber system … and to actually see the iLet prototype.  I wish I had this device NOW! (More on this in an upcoming post.)

Read more:        Coming Soon: ‘Artificial Pancreas’ Options for Diabetes
Artificial Pancreas is Coming, Other Highlights from ADA 2016
 

A Cure for Type1: A press conference called Beta-Cell Replacement pointed to 2 possible cures, still a ways off.

Dr. David Cooper at the University of Pittsburgh is working to genetically engineer pigs to produce beta cells that wouldn’t trigger their recipients’ immune systems (instead of forcing recipients to take large doses of immunosuppressant drugs).  That’s right, fix the pig, not the human!

Dr. Chad Cowan from the Harvard Stem Cell Institute, a co-founder of CRISPR Therapeutics, is trying to create genetically modified human stem cells that would be invisible to the immune […]

From diaTribe.org: Automated Insulin Delivery System UPDATES

from diaTribe.org by Adam Brown, Ava Runge and Nicole Kofman, 4/8/2016

This is a great snapshot of all the organizations working on automated insulin delivery products, including their plans for pivotal studies and plans for an FDA submission.  Assumption: a 12 month FDA process. The companies listed (based on shortest to longest time to a pivotal study, always subject to change) are:

Medtronic
Tandem
International Diabetes Closed Loop (IDCL) Consortium (TypeZero, UVA and 9 others)
Beta Bionics
Bigfoot Biomedical
Animas
Insulet
Cellnovo
Roche
Cambridge

See the full chart: Automated Insulin Delivery System Updates

The Savvy Diabetic: Artificial Pancreas Update

Updates from www.DiaTribe.org

Lots of news and updates are flooding the blogs regarding the artificial pancreas.  It is exciting (albeit not a cure).

At a recent Carb DM Bay Area Diabetes Summit, three experts on automated insulin delivery (aka, “artificial pancreas,” “AP,” or “closed loop” systems) discussed the current state of the field, what patients can expect with “first-generation” systems, working with the FDA, and future innovation. The power-packed panel included leading closed-loop researcher Dr. Bruce Buckingham (Stanford), Medtronic Diabetes’ Chief Medical Officer Dr. Fran Kaufman, Bigfoot Biomedical’s Director of Clinical Innovation Jen Block, and moderator Howard Look (Tidepool). According to DiaTribe, here are the key points (read in detail: http://tinyurl.com/hcw7vec):

Medtronic has completed a pivotal trial for their hybrid closed loop system, and hopes to sell it at a relatively comparable price to the cost of a separate CGM and pump system.  According to Dr. Kaufman, the biggest concern is who’s going to pay for it and what’s the cost going to be. Medtronic’s investment is huge (tens of millions of dollars on trials plus the FDA submission report which will be tens of thousands of pages long!).  Launch hope: April 2017

Dr. Buckingham said the FDA has “accelerated tremendously” on automated insulin delivery, which he attributed to the power of the patient advocacy community. One area of FDA uncertainty, however, is the approval process for next-generation improvements: what can companies update on their own without a long FDA process, and what will require more in depth review?

Glucagon:

There are a couple companies out there working on stable glucagon.
One of them is Xeris, which puts in something called DMSO to make it last for more than a year. However, it will freeze in the fridge.
There’s also a Danish […]

Savvy Updates 4/2/2016: Insulin Variability Overnight, Designing for Diabetes, and More …

  What Improves My Healthcare Experience
by Kerri Sparling, 26 January, 2016
Kerri Morrone Sparling has had T1 almost 30 years.  She writes a blog website called Six Until Me, which she started because “I was tired of Googling “diabetes” and coming up with little more than a list of complications and frightening stories.” Back then, Kerri was one of four or five diabetes bloggers … and she writes beautifully and speaks with great passion and a fabulous sense of humor.
This blog is excellent and very worth sharing.  In her closing paragraph, she says, “Life with chronic illness has taught me that the medical system is gross and broken.” Amen, Kerri.  I’m sure we could all contribute our experiences to her thoughts.
Read More from Kerri: What Improves My Healthcare Experience?
 

A New Era in Diabetes Design

Last November, I had the opportunity to attend the DiabetesMine Innovation Summit at Stanford University, with leaders in the diabetes world (product executives, FDA and government directors, user interface researchers and more).  To say the least, it was exciting and so very interesting.
I met Sara Krugman (a T1 since age 5) who is currently lead designer at Tidepool as well as the new iLet/Bionic Pancreas … and Katie McCurdy, lead designer at Open mHealth, user experience strategy consultant at UVM Medical Center and a Stanford Medicine X e-patient scholar.  These are 2 gangbuster amazing women!
They spoke of “good design” which understands and respects the context of its end users … and I felt instantly optimistic that perhaps finally product developers might listen to users and actually learn what is really important to us, as end users.
Thank you DiabetesMine … this is great reading.  A New Era in Diabetes Design
 

Overnight Insulin Requirements […]

The Savvy Diabetic Research Update: 9 March 2016

Senseonics’ Eversense: 90-day Implanted CGM Enters US Pivotal Trial
www.DiaTribe.org, 2/26/2016

This pivotal trial will evaluate the accuracy and safety of the Senseonics’ implantable, 90-day Eversense CGM system. Eversense CGM measurements will be compared to a laboratory reference device at several in-clinic visits over the 90-day wear period.

Current CGM offerings (Medtronic and Dexcom) in the US involve a sensor inserted through the skin and a transmitter that is attached externally to the body; these sensors last only seven days before they need to be replaced (though some people wear them slightly longer). Eversense uses a longer-term, 90-day implanted sensor, which is placed in the upper arm in a simple 5-10 minute in-office procedure. Since the sensor doesn’t contain a battery, a transmitter device is worn externally over the sensor to power the sensor and send the data to a smartphone. Both the smartphone and transmitter will alert the user of a high or low. Even if the phone is out of range, the transmitter will provide on-body vibe alert to indicate a high or low. Senseonics has completed a pivotal trial in Europe, where Eversense is still awaiting approval. If this new US trial finds the Eversense system is safe and effective, it opens the door for a US FDA submission.

For more information about the trial, please contact Emily Gades at 925-930-7267 or egades@diabloclinical.com, or from ClinicalTrials.gov, go to http://tinyurl.com/zlnrqxq

 
CU scientists identify factor that may trigger type 1 diabetes
Aurora, Colorado, 11 February 2016
A team of researchers, led by investigators at the University of Colorado School of Medicine, have identified a new class of antigens that may be a contributing factor to type 1 diabetes, according to an article published in the 12 February 2016 issue of […]