September 19, 2014

The Bionic P With Katie C

In case you missed it, Katie Couric has a great story on Ed Damiano.

Enjoy!


 

September 16, 2014

OmniPool? TidePod?

Congratulations to both, either and the combination. From the post on Tidepool's site:

Insulet and Tidepool

Raul Oliva, Marketing Director at Insulet

Insulet is pleased to announce we are opening our data protocol to Tidepool to enable OmniPod users to upload their insulin pump and integrated blood glucose meter data to the Tidepool platform and future Tidepool applications. With the announcement from Dexcom regarding their agreement with Tidepool in August, users of both OmniPod insulin pumps and Dexcom continuous glucose monitors will see their data from both devices in one place in future Tidepool applications. (more)

http://tidepool.org/2014/09/16/insulet-and-tidepool/

September 3, 2014

From the News Wire: CE Mark for Abbott's New Glucose Monitoring System

From The Abbott Press Release

ABBOTT RECEIVES CE MARK FOR FREESTYLE® LIBRE, A REVOLUTIONARY GLUCOSE MONITORING SYSTEM FOR PEOPLE WITH DIABETES

ABBOTT PARK, Ill., Sept. 3, 2014 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that it has received CE Mark (Conformite Europeenne) for its FreeStyle® Libre Flash Glucose Monitoring System, a revolutionary new glucose sensing technology for people with diabetes. The system eliminates the need for routine finger pricks1, reading glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days. In addition, no finger prick calibration is needed—a key differentiator from current continuous glucose monitoring systems. The system will be available in seven countries across Europein the coming weeks. 
Abbott′s FreeStyle Libre System consists of a small, round sensor—approximately the size of a two Euro coin—worn on the back of the upper arm, which measures glucose every minute in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad. A reader is scanned over the sensor to get a glucose result painlessly in less than one second. Scanning can take place while the sensor is under clothing2, making testing more discreet and convenient. Each scan displays a real-time glucose result, a historical trend and the direction the glucose is heading. The reader holds up to 90 days of data, providing a historical snapshot of glucose levels over time. The FreeStyle Libre System software enables the data to be presented in a user-friendly, visual chart for both healthcare professionals and patients, driving a more productive discussion around treatment and any necessary modification. 
"The FreeStyle Libre System fulfills a major need for people living with diabetes," said Robert Ford, senior vice president, Diabetes Care, Abbott. "Our customers told us that the pain, inconvenience and indiscretion of finger pricking were the key reasons they weren't managing their diabetes as well as they should. Addressing these concerns has guided the development of FreeStyle Libre – a transformational product designed to not only remove the pain of finger pricking but also seamlessly integrate into their daily lives."  
The FreeStyle Libre System will be available in France, Germany, Italy, Netherlands, Spain, Sweden and United Kingdom in the coming weeks and will be available for purchase online through a website in each market. 
More including footnotes:

http://abbott.mediaroom.com/2014-09-03-Abbott-Receives-CE-Mark-for-FreeStyle-Libre-a-Revolutionary-Glucose-Monitoring-System-for-People-with-Diabetes

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.