August 28, 2014

Unexpected Ways the DOC Improves Diabetes

I am a fan of community. The diabetes community in particular and the value it bring by connecting peers and empowering self care. Those connections do even more. 



Our friends at Glu just posted an article about an infusion set study. These days in and evidence based health environment studies matter. What's that got to do with community? Well by reaching out to the community Glue filled over 80% of the study, in just two days. Glu helped the community help itself    with faster studies. Heres is what the studies Alysa Sampson Perrin said:
“We were very fortunate to be able to conduct this study using Glu, it allowed for rapid recruitment with over 200 of the 243 total participants enrolling within 2 days of announcing the study."


One month ago advocates let by Anna McCollister-Slipp had a conversation with FDA on Medical Device Data Systems. In that FDA asked for patents views on the risk and benefits of data, specifically real time data from CGM moving to a device data system to other displays. YDMV wrote the it here.  In one month, with enthusiastic support from the CGM in the Cloud Facebook group the community put over 500 comments into FDA's open docket. I think that is a record response from the diabetes community to a FDA request for comments.

Our community is strong, we support each other, we empower research, we work with regulators and we can do more. My friend Michael outlines that vision:


Be a part. Take the MasterLab survey.


August 12, 2014

CGM improves T1D care in PWD over 65 - AACE

AACE just published a paper on CGM use in People over the age of 65. The paper concludes:
Insulin-requiring patients 65 years old and older in our retrospective study from a community endocrine practice achieved a significant and durable improvement in glycemic control when using PCGM. The improvement in glycemic control was comparable to that reported in younger patients. The substantial reduction in severe hypoglycemia may be of particular benefit in older patients. Lack of PCGM coverage by CMS was the most common reason sited to not start or to discontinue PCGM use. 

Significant
Substantial


The goal of every adult with type 1 diabetes, every parent of a child with type 1 diabetes and every person in the care teams of those people with diabetes is a long health life WAY past age 65.

To better understand why this matters, please read Kerri's excellent piece at diaTribe on CGM and Medicare. I trust you will feel moved to sign the JDRF's petition. Like Kerri says, use the #MedicareCoverCGM hashtag to help thread these stories through social media like Facebook and Twitter.

I fear it may be a long term process to help provide good diabetes care to those on Medicare. Long term processes star with a step. There first step is the petition. More steps to come.

Think about your story with CGM. Has it helped you? Here are some tips on how to tell you story as an advocate for CGM coverage:

Tips:
  • Plain language. Avoid jargon and abbreviations, tell you story like you are talking with a sympathetic friend over coffee.
  • Speak from the heart, and to it, your passion should be in the story, up close and personal.
  • Talk about success, make your story be the uplifting example of how things can be better.
  • Be concise. Use details from your success to connect passion and policy.
  • Quality of life over numbers. We want to hear about you and your life. If you use statistics be sure the are accurate and relevant to your personal story.
  • If possible, craft a way for policy makers to be a hero by demonstrating to them how their actions help you stay healthy and successful.
from: http://www.cgmsafely.com/stories/tell-your-story/



#MedicareCoverCGM


Links included in this post.
http://aace.metapress.com/content/t452w5j078414954/fulltext.pdf
http://diatribe.org/issues/67/sum-musings
http://www.thepetitionsite.com/takeaction/776/978/446/
http://www.cgmsafely.com/stories/tell-your-story/

August 11, 2014

Sanofi and MannKind Announce Licensing for Afrezza®

Sanofi and MannKind Announce Global Licensing Agreement for Afrezza® (insulin human) Rapid-Acting Inhaled Insulin
Paris and Valencia, Calif. - August 11, 2014 Sanofi (EURONEXT: SAN and NYSE: SNY) and MannKind Corporation (Nasdaq: MNKD) announced today that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza® (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies plan to launch Afrezza in the United States in the first quarter of 2015. 
Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities. Under a separate supply agreement, MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Connecticut. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary.
More:

FDA Approves T2D Drug Combination of SGLT2 & Metformin

From the Jansen press release:

Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKAMET, a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes. INVOKAMET provides the clinical attributes of INVOKANA® (canagliflozin), the first sodium glucose co–transporter 2 (SGLT2) inhibitor available in the United States, together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes. INVOKAMET is the first fixed–dose combination of an SGLT2 inhibitor with metformin approved in the United States.

August 5, 2014

DOC @ AADE

On Friday, Aug. 8 from 9:45AM-11:15AM (EST), I will be joining Kerri Sparling, Jill Weissberg-Benchell and Jen Block to present The DOC Rx: The Role of Social Media in Managing Type 1 & 2 Diabetes at AADE’s annual meeting.

Our presentation’s intent is to validate the role of peer support in diabetes management. Jill and Jen will explore thoughts gained from reviewing Kerri’s and my lives with diabetes, as well as out interactions with the DOC. Jeff Hitchcock is moderating.

I am thrilled to be part of a panel with these super smart folks.


- Posted using BlogPress from my iPhone

August 1, 2014

FDA Approves another (SGLT2)

FDA approves Jardiance to treat type 2 diabetes: Jardiance

The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. Type 2 diabetes affects approximately 26 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage. For more information, please visit: Jardiance.

July 28, 2014

Let’s Put on a Show! (aka FDA has open dockets)

FDA has a docket open seeking public comment on Medical Device Data Systems (MDDS.)

What is that you ask? Good question.

A MDDS is a systems that, in the FDA words, facilitates, “the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.” In other words provide second screens for information. FDA is proposing lessening the regulatory process for MDDS as they introduce little additional risk. I agree.

For people with diabetes this may mean seeing our information on additional screen such as our phones. Go FDA!

The guidance speaks directly to mobile.

It is unclear how CGM data is viewed for this data. FDA specifically draws a line at active patient monitoring in the guidance. They don’t exactly say what that is. In my view is that is meant to be in clinic critical care monitoring, not patient self monitoring such as CGM.

I hope to help FDA make that distinction by sharing my views. I would love some company helping FDA see how PWD feel about information.

So far there are two (2) comments on the FDA docket. That seems hardly enough.




One of the keys to successful advocacy is getting attention. I have talked a lot about how much I love the paper Back to Basic as a model for diabetes advocacy. Now the book is a block buster summer movie. (OK part of the paper is in this Youtube video from MasterLab.)




In my view one way the diabetes community can get attention is to speak up in droves when FDA is listening. MDDS isn’t the sexiest subject in the world, neither are food labels (http://diabetesadvocates.org/tell-fda-your-thoughts-on-the-proposed-nutrition-fact-label-by-aug-1/) but if we don’t show up when the policy makers are listening how can we claim we need to be heard?


Please comment on food labels. The docket is open to August 1.

Comment on MDDS, it is open August 25.

Let’s get policy makers attention. Let’s put a show making of comments into the dockets.

July 15, 2014

Novartis Joins With Google on BG Contact Lense

From the NY Times:

Novartis Joins With Google to Develop Contact Lens to Monitor Blood Sugar 
LONDON — Google announced on Tuesday a partnership with the European drug maker Novartis to develop a smart contact lens with the potential to monitor the wearer’s blood sugar levels.

http://www.nytimes.com/2014/07/16/business/international/novartis-joins-with-google-to-develop-contact-lens-to-monitor-blood-sugar.html?_r=0

KISS Advocacy - ThePrefect D

I love the piece, the KISS of Diabetes Advocacy by Christel over at the Perfect D.

Her's is spectacular show of how advocacy can be simple and how it can be effective. The more of us who jump in the simpler it can be, In a counting game winners tally up the score. That is what diabetes needs to help avoid the untended consequences of poor public policy.

What sets this piece apart is she makes her case in an upbeat, face painted Rock 'N Roll way.

Advocacy can be fun, as a choice of attitude and Christel's is on the money.

Here's the link, surf on over and have a look.

http://theperfectd.com/2014/07/14/the-kiss-of-diabetes-advocacy/