December 1, 2014

Animas® Vibe™ Insulin Pump and CGM FDA Approved

The Vibe has been approved by FDA!


Integrated System Streamlines Diabetes Management for Patients 
CHESTERBROOK, Pennsylvania, Dec. 1, 2014 / PR Newswire / — Animas Corporation today announced FDA approval of the Animas® Vibe™ insulin pump and Continuous Glucose Monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older. As the first and only integrated system featuring Dexcom G4® PLATINUM sensing technology with proven accuracy, Animas® Vibe™ allows patients to view glucose data and administer insulin right from the pump; simplifying and aiding their ability to make more informed decisions to fine tune insulin delivery and manage their diabetes. 
Animas is now accepting orders for Animas® Vibe™ and anticipates shipment to patients to begin in January 2015. For more information, visit www.animas.com

More: http://www.multivu.com/players/English/7312951-animas-corporation-vibe-insulin-pump-continuous-glucose-monitoring-system-fda-approved/ 

November 30, 2014

I am for, "Patient Participation in Medical Product Discussions"

FDA has a very short term docket (30 days closes on Dec 4) about Patient Participation in Medical Product Discussions. Right smack in the middle of Diabetes month Thanksgiving. Not ideal comment time. 
So DOC, we need your help. 

Stephen Shaul started the ball rolling to get some comments in. The goal of comments is to be complimentary of the 2014 actions FDA has taken with the diabetes community and ask to keep that going, and maybe step that up with a PDUFA meeting.
If you can cut paste a comment great, if you can riff on the talking points making you comments similar but unique, even better. Everything you need is here: http://www.stripsafely.com/comment-on-patient-participation-with-fda/
Personally I would like to see most o the comments in the docket be on diabetes issues. Let's dominate the docket. 
Time is short. 
Thanks for stepping up.

November 21, 2014

Peer Support through Activity Apps

Adam has a great post at diaTribe. I know, I know... Saying 'Adam' and 'great post' is redundant. Adam is the very definition of great posts.

It is just this particular one has me thinking about peer to peer support in a different way. We often cite the emotional value of not being alone with diabetes. That is big, huge. No question.

My current place on the diabetes continuum is very much dominated by getting my ass in gear. Here is a happy little workout blues riff on the topic, "Can't Get My Ass In Gear" - Coco Montoya." I love that tune. I don't remember who put me on to it I think it was Rex. I hope so 'cause it is his humor.

So clearly iTunes is a great app but while it may play tunes on the subject it doesn't really get my ass in gear. I need some encouragement for that. That is what Adam talks about.  He writes of health apps:
Friendly encouragement from friends. I’m a huge fan of the social aspects of activity tracking – whereby you can “follow” your friends, give them encouragement, and challenge each other. This might sound like it could be cutthroat or competitive, but I’ve found it to be the exact opposite. Even the language used (e.g., “Cheer” [Fitbit], “Kudos” [Strava]) speaks to the positive atmosphere that these apps seek to foster. According to Fitbit’s McDonough, for each extra friend someone has on the Fitbit system, his or her activity increases by 750 steps per day. Based on my conversations with friends, however, the social features are not for everyone – some don’t want followers! Fortunately, you can toggle these on or off as you desire.
I was spectacularly intimidated when Adam first reached out to "share workouts." Read his bit, he is fit and motivated. I am neither, see the aforementioned "ass in gear" issue. I didn't want to even think about being in the same league as Adam. I am not but that is cool, that ain't the point. The point is supporting each other.

Adam and others are very much part of my peer support system now.

The encouragement factor is real and so very true. A "Kudo" means a lot to me. It means I am not alone in efforts to get my ass in gear. Hey.. wait... see that? It is about not being alone. It is about having someone with you, not as a competitor but as a supporter of progress. Each kudos is a sticker of progress. Each feel good and so does sharing them.

So my thanks to Adam, Jenny, Lane, Mike and Mari for the Kudos on Strava.com.

Need help getting your ass in gear? Maybe a few kudos will help. A little Coco Montoya help too. Join me on Strava.






Do the #BigBlueTest all year, your #WalkWithD and be a walk, ride, run, jog, swim, lift, what ever. Find and support and be supported by peers.


October 23, 2014

Please Register for #DOCasksFDA. NOW!






FDA and diaTribe invite you, her, him and all the rest of the DOC to join an unprecedented patient dialogue on November 3 from 1-4pm EST - you can register for the online webcast at:  


Even if you are only available for part of the conversation, I strongly encourage you to sign up and join the virtual discussion based on our recent collective feedback.

As a community, it is essential that we show the FDA how committed we are to more open communication. Please register and join as a signal to the Agency that you are interested in dialogue, have valuable input to share, and want to advocate for better treatment options for diabetes.

Thanks so much to everyone at FDA and diaTribe for making this possible!

October 20, 2014

Big Blue Test



Today, when I ride my bike, I'll do the Big Blue Test. What activity will you do when you do the Big Blue Test

Here is what I'll do:

1. Test My Blood Glucose.  (If you do not have diabetes, you can skip the testing steps.)
2. Get Active. I will ride my bike!
3. I'll Test Again.  After riding. In the past, on average, Big Blue Testers have seen their blood glucose level drop 20% after 14-20 minutes of exercise.
4. I'll Share My Results.  Answer the questions in the right column of this page. And don’t forget to talk about your experience on social media.

Download the App

    Big Blue Test diabetes exercise app available in itunesBig Blue Test App available in Google Play 
    Animated_Excited

#Vote4DM


StripSafely is at it again! #Vote4DM is a targeted awareness campaign that lets you tell Congress you know that there are three bills related to diabetes on the Hill and they need act on them. Go to StripSafley.com and  click Vote4DM above or TWITTER below. 

Easy.

Our Ask


  • Join  Tweet-ins 8:00 PM-ish eastern on October 22 and 29.
  • Go here http://www.stripsafely.com/the-twitter-page/
  • Find your elected officials.
  • Click the 3 links. Coordinate, Educate and CGM for your Senators and Representative. (Bonus points for Tweeting Congressional leadership too.)

We figured out who is in the diabetes caucus, who has already cosponsored what, and the bill numbers and adjust the Tweets to fit.

All you do is Point and Click, what could be easier?

The Point

"It is impossible to move someone to action without first getting his or her attention," Back to Basics. So lets use simple tools to get attention, when Congress is listening, aka a few days before the election. Will it change a lot of their minds? No.

This it help a process of getting attention, start the wheel squeaking and our community asking. 

DEXCOM Share Approved

From the News Wire:

FDA Approves Dexcom SHARE™, the First Remote Mobile Communications Device Used for Continuous Glucose Monitoring (CGM)
Now critical glucose data from the Dexcom G4® PLATINUM Continuous Glucose Monitoring System can be remotely monitored using a mobile device 
SAN DIEGO--(BUSINESS WIRE)-- Dexcom, Inc. (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its CGM remote mobile communications device: Dexcom SHARE. Dexcom SHARE, an accessory to the Dexcom G4® PLATINUM Continuous Glucose Monitoring System, uses a secure wireless connection to transmit the glucose levels of a person with diabetes to the smartphones of up to five designated recipients, or “followers.” These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere via their Apple® iPhone® or iPod® touch. With Dexcom SHARE, parents and personal caregivers can monitor a child’s or loved one’s glucose data from a remote location, giving them peace of mind and reassurance when they are apart.  
“Dexcom SHARE represents a significant advance in diabetes care by allowing people with diabetes to share important glucose information with their loved ones from afar,” said Terrance H. Gregg, Chief Executive Office of Dexcom. “With Dexcom SHARE, users, parents and personal caregivers now have a new tool to dramatically improve how they communicate about their diabetes.”

Disclosure: I have Dexcom Share but that has little to do with pleasure at seeing this. 

October 15, 2014

Hey Adam needs a hand, Little help?

This is from my good friend and inspiration to bicycle, Adam Brown at diaTribe. Help him out OK? Just to be clear, diaTribe is asking to help better focus on what matters to PWD when we do the next round of #DOCasksFDA, not FDA asking. Go us!
Hello DOC friends! 

On November 3, the FDA will host an unprecedented discussion between the diabetes community and senior agency leadership (both drugs and devices). The event will be live webcast from 1 - 4 pm. We want this to be nothing short of a home run. The event will include a panel of patients (T1 and T2), as well as representatives from ADA, JDRF, and diaTribe. As a community, our job is to present the numerous challenges we as patients face each day, and we need as many opinions as possible to be a part of this discussion! With FDA, ADA, JDRF, and dQ&A input, we have created a survey posted at www.diaTribe.org/surveyWe are asking the entire diabetes community (T1 and T2!) to please fill out this short survey and share thoughts on what's important when it comes to living with diabetes. This feedback will go DIRECTLY to FDA and help influence the conversation on November 3

FDA is currently working on the registration to sign up for this webcast event; as we understand it, this should be posted within the week. We will be in touch with that information and a finalized agenda as soon as we have it. For now, it is mission critical to have a massive response to the survey. We need to show the FDA that patients care about these issues, that patients have valuable input to share, and that the treatment options we have are still not good enough.

Thank you on behalf of our entire team for your help in spreading the word on the survey and about the event. We’re truly excited about the potential to open the lines of communication with the FDA, which for too long has been a black box. We need more patient input into the drug and device approval process, and we see November 3 as a very key avenue to making that happen. Let’s show the FDA how committed our community is.

very best wishes,
Adam



October 7, 2014

Glooko Launches ‘MeterSync Blue’

From: http://www.prweb.com/releases/2014/10/prweb12217624.htm

Glooko Launches ‘MeterSync Blue’ to Bluetooth-Enable Tens of Millions of Blood Glucose Meters Worldwide
With the addition of 'MeterSync Blue,' Glooko's diabetes management platform enables remote patient monitoring by syncing blood glucose readings from more than 30 meters to supported Apple and Android devices. 
Glooko Inc., announced today the launch of Glooko MeterSync Blue, strengthening its position as the industry leader in delivering a mobile, software as a service (SaaS) diabetes remote monitoring and population management platform. Now patients can utilize Bluetooth to connect any of more than 30 popular blood glucose meters to the Glooko platform on Android or Apple devices, as an easier alternative to a physical connection with the current Glooko MeterSync cable.
With the addition of the Glooko MeterSync Blue – featuring Bluetooth Smart™ and Glooko’s FDA-cleared technology - the company’s diabetes management platform provides health systems and payer groups the ability to more cost-effectively enroll diabetes patients into remote monitoring programs without the need for patients to switch to costly, wireless-enabled, blood glucose meters developed specifically for telemedicine. Instead, health systems and payer groups can leverage the tens of millions of meters already deployed to patients worldwide.

October 6, 2014

Pediatric Vibe Approve in the Great White Northland

From the press release: 

Animas® Vibe® Insulin Pump and Continuous Glucose Monitoring System Now Approved for Children with Type 1 Diabetes in Canada

BURNABY, British ColumbiaOct. 6, 2014 /CNW/ -- Animas Canada, a division of LifeScan Canada Ltd., today announced the launch of the Animas® Vibe® insulin pump and Dexcom G4® PLATINUM continuous glucose monitoring (CGM) system, for the pediatric market1 in Canada.
"Earlier this year, we introduced Animas® Vibe® to adult Canadians living with diabetes, so we are pleased to expand this offering to the pediatric population," said Paul Flynn, North American Sales Director, Animas Corporation. "Now children and their parents can manage their diabetes with a system that combines a world class insulin pump with state-of-the-art CGM technology."
More: http://www.newswire.ca/en/story/1423474/animas-vibe-insulin-pump-and-continuous-glucose-monitoring-system-now-approved-for-children-with-type-1-diabetes-in-canada