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


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:
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

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 


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 and  click Vote4DM above or TWITTER below. 


Our Ask

  • Join  Tweet-ins 8:00 PM-ish eastern on October 22 and 29.
  • Go here
  • 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 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,

October 7, 2014

Glooko Launches ‘MeterSync Blue’


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."

September 19, 2014

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)

September 3, 2014

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

From The Abbott Press Release


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:

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. 


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:

  • 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.


Links included in this post.

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.

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


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 ( 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.

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.

Stanford research develops news way of diagnosing T1D.

From the SF Chronicle:
A Stanford University team has developed a small invention to spot an increasingly large health problem: Type 1 diabetes. 
The palm-size chip can analyze a few blood drops and diagnose the disease in new diabetics, as well as identify people who are at risk of developing the disease, the scientists say. They are filing for a patent, seeking federal regulatory approval and helping to form a startup to commercialize the chip, which they say works more quickly and is cheaper than existing diagnostic tools.

July 7, 2014

Jerry the Smart Bear IndieGoGo

Look everyone needs a smart bear, iBear, scholar bear or in the case of T1 kids a friend they can care for.

Jerry has a crowd source opening today. Jump in. Everyone needs a bear.

This is how I imagine Jerry graduating.

Jump in:

- Posted using BlogPress from my iPhone


June 4, 2014

Medtronic Combines Set and CGM - @DiabetesMine

Good Friend, Mike Hoskins has a write up on Medtronic combination CGM sensor and infusion set that has been introduced in Europe, over at DiabetesMine. Well worth a click, here is a little tease of what he has to say:

Medtronic is leading the charge on new diabetes devices again, with a first-of-its-kind combo device launched in Europe that brings a continuous glucose monitoring (CGM) sensor and insulin infusion set together into a single device with combined insertion capability!
The company announced its launch of the Minimed Duo on Tuesday, after getting CE Mark approval for European sale early this week.
The new Duo uses the Minimed Veo system (which is the 2009-approved European version of thenew Minimed 530G system that was approved in the U.S. last fall) and the accompanying Enlite sensor.
The magic here is that the Duo merges the insertion needs for both insulin infusion and CGM monitoring into just one spot on the body — instead of two different sites on your body as has always been required. Note that this is not the full dream of a single cannula — you’d still have two puncture spots on the skin where the steel catheter and glucose sensor go in — but you’d only have to push one button on a single, combined inserter to place both your insulin pump and CGM automatically, plus the needles retract so you don’t have to see them.

May 22, 2014

Surveillance Success!

Good News!

The Diabetes Technology Society (DTS) this week announced the launch of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This surveillance program will provide independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance against accepted standards, and generate information that can assist patients, healthcare providers, and payers in making the right product selection.
Initially the program is being supported by Abbott but DTS says that other BG Monitor manufacturers are currently looking into coming on board.  They (and I think all of us in the community) would welcome funding from other sources that recognize the importance of and wish to lend their support to surveillance of cleared BG Monitoring systems to obtain information about the performance of these products.
The announcement says there will be patient advocates involved. I asked DTS who that would be and they replied, "Patient advocacy groups will be selected based on recommendations by the Steering Committee and the Board of DTS." I may have thoughts on the matter too. 
Finally I asked, what do we need to do to make surveillance mandatory, because, I assume it will start as voluntary?
DTS's reply was, the program can be made mandatory if a special rule is developed by FDA or if a law is passed by Congress.

So there is still advocacy work to accomplish.  

May 12, 2014

Access is the point of Advocacy

The prompt for today:

Let’s kick off Diabetes Blog Week by talking about the diabetes causes and issues that really get us fired up. Are you passionate about 504 plans and school safety? Do diabetes misconceptions irk you? Do you fight for CGM coverage for Medicare patients, SDP funding, or test strip accuracy? Do you work hard at creating diabetes connections and bringing support? Whether or not you “formally” advocate for any cause, share the issues that are important to you.

All of the above,
and then some.

Diabetes is Big. Policy is Big.

They touch at a lot of different points. Because both are big, often one touch point doesn't know what the other is trying to do.

It would be glorious, for example, if efforts at prevention were connected to the key idea of access via insurance reimbursement for quality education on how to successfully prevent or at least postpone type 2. Great if third party payers looked at education as the investment in saving lives and expenses down the road that it is, sadly it is not always seen that way.

The list of issues in the prompt seem quite different;

  • 504 and schools
  • Misconceptions
  • CGM and CMS
  • Special Diabetes Program
  • Test Strips
  • Connections with peers

I don't see it that way. To me they are all access to issues:

  • Access to safe school environments.
  • Access to accurate public messages about diabetes.
  • Access to treatment and technology to continue to successfully manage diabetes.
  • Access to research to better treat diabetes. 
  • Access to reliable devices.
  • Access to people who can help individuals stay positive and engaged. 

Advocacy is acting to ensure access. What people need access to may, like diabetes, vary. The need to act with and for each other doesn't vary. If we don't act for better diabetes access, who will?

May 6, 2014

MasterLab - July 2, become a better policy advocate.

Become a stronger champion for effective diabetes policy.
July 2, 2014 7am – 5pmOrlando World Center Marriott
Speakers include:
  • Patient advocates from other diseases
  • FDA
  • Government  and Regulatory Affairs representatives from device and pharmaceutical companies
  • Other experts.
Understand the role of patients, empower diabetes advocates:
  • Policy, regulatory issues
  • What advocacy looks like now and where we can improve.
  • How can patients be effective in the policy landscape?

Diabetes Hands Foundation offers this MasterLab in collaboration with Children with Diabetes (CWD). Registered participants in CWD’s Friends for Life conference are welcome to join the MasterLab as part of their FFL experience at no additional cost. 
Please email for a promo code 
to use for free registration for the MasterLab.

Then register here.

*Stand alone registration for the MasterLab is $50 per person for those not registered  as Friends for Life participants

May 2, 2014

Yo DOC! How do ya feel about 400?

Comments that is.

We are at 342.

If posts to the FDA docket on personal use glucose meters were held to the 2003 ISO standards for glucose meters, I could claim we have 400 comments and consider that an accurate reflection of 342.   342+20%=410.

That's bogus. Let's get a real 400. Commenting is easy. It takes two minutes.

The docket is open to May 7.
That's one place where a 400 is something to feel good about:


April 29, 2014

Yes, Who is accountable? FDA Notice on Generic Strips

StripSafely asked Who is Accountable for generic test strips.  Apparently it is not a academic question. FDA today release a warning titled, "FDA Safety Communication: Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results"

From that release:
Identify whether you are using GenStrips glucose test strips. The strips may be packaged in green and white packaging with the GenStrip name on top, similar to those shown below.

For People with Diabetes:
  • Discontinue use of GenStrip Blood Glucose Test Strips.
  • Obtain alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
  • Ask your pharmacist or contact your diabetes care provider if you need help determining which test strips to use with your glucose meter.
  • As always, be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). If you experience symptoms of either high or low blood sugar, contact your diabetes care provider for advice on treatment.

4/30 Update: Please see this MarketWatch report on the issue. GenStrip's Acquiring company states they will replace strips.

Help FDA understand how generic strips can be part of their new guidance structure. Comment to the dockets and ask for clear rules to protect PWD. Copy and paste the draft comments from StripSafely below to the FDA docket HERE.


I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypo range) are a big step forward. The new emphasis on test strip lot release criteria will lead to better quality control, and the requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies – and allow users to make informed choices.


Third Party Strips – Who is Accountable?
In the introduction to its proposed guidance on blood glucose meters, FDA speaks of self-monitoring blood glucose test SYSTEMS (SMBGs – caps mine.) This terminology is important because of its clearly implied meaning:  a meter and its strips are a complete system, designed to be used together.
Why is this important?
There are several reasons:
One is liability. When a third-party manufacturer makes test strips for a meter it is unclear who should be responsible for maintaining the system’s integrity and who would be held accountable in the case that something goes wrong:  the meter company, the strip company, caregiver or the patient.
Generic strips are approved for use with meters sold before specific dates. The data a meter is sold is not always clear. Patients need clarity.
FDA draft guidance speaks of third-party strips starting at line 990 of the over the counter draft guidance (1050 of POC) saying. “We strongly recommend that agreements between the third-party strip manufacturer and the meter manufacturer are in place to ensure that the third-party strip manufacturer is made aware of any design changes to the meter. In cases where this is not possible, the third-party strip manufacturers should sufficiently address, in their submission, how they will mitigate the risk of incorrect results due to meter design changes.”
That is not an academic issue. Insulin is a very dangerous drug that puts over 97,000 American in the emergency room each year.  A recommendation is not enough.  The FDA’s final guidance on blood glucose meters and strips should require formal agreements (and plans) between meter manufacturers and third-party strip manufacturers as part of the criteria used for clearance. Until these standards are in place, third-party strips should not be considered part of a system. Without bing part of a system the should not be cleared for sale. Patient lives are at stake.

Additional third party strip considerations

RESPONSIBILITY – I hope FDA clearly defines who is responsible/liable when an adverse event occurs as a result of the use of a third-party strip.
ACCURACY – Third-party strips should be be held to the same standards of accuracy as all blood glucose test strips. Accuracy should advance. Strips that fail to meet new accuracy standards set by this guidance should be rapidly phased out of the market.
POSST MARKET SURVEILLANCE  - There should be a program in place to ensure the quality and accuracy of all meters and strips, including third-party, after the meters and strips have been cleared for sale
RECALL – Recalls of all strips and meters are an important post market protection. Options to recall must stay open and include third-party strips. In the case of a recall communication to users of a SYSTEM are important. Clear guidance should be in place to ensure that the safety of patients using systems that include third-party strips is not compromised.
MDR – The FDA should require all strip and meter manufacturers to establish clear procedures for Medical Device Reporting in the event of adverse events related to these meters or strips. Third-party strips will add complexity to the submission process; before they are allowed to enter the market, third-party strip manufacturers must establish a clear, robust and simple process for tracking and submitting MDR.
DME – The FDA should make clear in its guidance documents that systems of meters and strips (including third-party) that do not meet the FDA’s stated accuracy requirements cannot be considered durable medical equipment (DME) and thus should not be eligible for reimbursement by CMS or other payers.
THERAPY ADJUSTMENTS Therapy Adjustments: the FDA should also make clear that if a meter and strips cannot be used to “make therapy adjustments” — meaning to dose insulin or calibrate a CGM — then they are, by definition, not a blood glucose meter  (or strip) and cannot be considered DME (and thus cannot be reimbursed as such).
LABELING: Who is going to be responsible for keeping an accurate and up-to-date list of which third-party strips work with which meters? Until this issue is clarified, third-party strips should not be cleared for sale.
Until all of these issues are addressed, third-party strips cannot be considered parts of a self-monitoring blood glucose test system, and should not be cleared for sale.

April 23, 2014

Dear Newbies

Welcome to the type 1 parents club. (Including but not exclusively, Usher and family) I am so sorry you have joined but glad at least you are here. The locals call here, the DOC  (we pronounce each letter for Diabetes Online Community.)

I kinda know how you may feel. I have been through it. Twice, yes two kids with type 1.  But you Diabetes May vary and you anxiety at diagnosis is your own.

If diabetes has taught me anything it is to try to have empathy for others, other parents of kids with diabetes, other people with type 1, type 2, what we call type 3 (other parents and caregivers.) In time, I hope you get to the place where you can see empathy as a blessing.

You ain't there now. You ain't meant to be. Don't sweat it. There are a bunch of stages of loss, you are gonna deal with them. That is 100% normal.

Type 1 diabetes is a family thing. No parent likes putting insulin into a child, the child typically isn't a huge fan of it either. All try to be brave. Siblings face as much stress as anyone, through less parental attention and care and loving fear for their brother or sister. As you work diligently to learn to care for you child with diabetes, work as just as hard to show the non D-kids how much you care for them and the love all they bring to the family. Life has many demands, diabetes will add to them, for now bring all you can to your family - you will find a new normal.

Learn about Children With Diabetes Friends for Life.

There at Friends For Life, families share the magic of "getting it." Everyone "get its." No matter how much or how little anyone knows there are new things to learn and new friends to walk with you.

Your family needs people walking with them. Diabetes is hard. It is relentless. It is best managed with a little help from your friends. Nothing against your existing friends, they are wonderful people I am sure, few will appreciate that behind what you project as normal is the ever present reality of diabetes care. A few may prove they weren't true friends, such is life.

The diabetes community will embrace you, peer support makes diabetes care much less stressful. Join the forums at CDW, join #DSMA chat on Wednesday nights 9:00 easter on twitter. Let other walk with you. You can do this.

Over the years YDMV has created a collection of Newbie posts, most are silly. There are here if you need them. There are also a few focused on that "why me" stage, those are here.  What really matters is we, a community who gets it, are here and here and here and here.... well way to many places to list, but all are here for every newbie, parent, adult, child, teen, caregiver and friend living with diabetes.

Welcome to the club. Sorry you are here. 

April 22, 2014

I can’t get no....

Family history can be cool.

The baby here is my dad. The Navy officer my granddad Vernon,  Fred C. Dunlap my great grandfather is on the left. The awesome 'stache in the middle is George W. Dunlap my Great Great Grandfather. He was on the receiving end of Pickett's Charge. For his sake, and all the rest of us that have come after, that small stone wall at the "high water point" is looking real good.

Some place in that picture, is a history of type 2 diabetes. It may suggest full on T2D, for me, is just a matter of time. I am what some folks call “Pre” type 2.  Nothing against the family history, I want to stay on the “Pre” side of the T2D time line.

I could use a stone wall of my own.

I have made changes in how I eat and some of what I do. I can still do better. My fasting numbers have been creeping up, so my Doc. and I chatted.

I want to know more about continuing to “pre”venting what seems like just a matter of time. I have concerns about medication, one I take may elevate blood sugar. I worry that metformin, as an glucose management medication entry point, may be an issue with my less than stone wall stomach. (If I look at meds the wrong way, I get queazy. One reason why I don’t like to take meds at all.)

At first a dynamic that was proactive about glucose management rather than reactive had Doc a little off his game but he bounced back quickly. I wanted to start with education. He was game but...

I needed to see what my insurance covers.

Joy! What is more fun than calling the insurance company?
(Sarcastic comments welcome, _____ is more fun than calling the insurance company.)

Here's the thing. I have had some success with A1C. Like I said some call it “Pre.” I am more aligned with Riva on "Pre" not being a real thing. Still, I am less than some thresholds of full on T2D. Like my insurance company's. They say by their measure it ain’t high enough. I can’t get no education.

Ever notice how many tunes have Doctor in the lyrics? All those songs about doctors and this is what rings in my head.

I can't get no, oh no no no
Hey hey hey, that's what I say
I can't get no, I can't get no
I can't get no education
No education, no education, no education