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.

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.

For details please see: http://diabetestechnology.org/surveillance.html

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.  

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.

Yes.
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?

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?

More Information on MasterLab

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 Mike@diabeteshf.org 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

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:

Please:

Comment on the Guidance

Add a Second Comment on Generic Strips

Watch the #DOCasksFDA Chat.

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:

Recommendations:
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.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm395180.htm

4/30 Update: Please see this MarketWatch report on the issue. GenStrip's Acquiring company states they will replace strips.  http://www.marketwatch.com/story/decision-diagnostics-responds-to-shasta-technologies-fda-safety-warning-letter-2014-04-30

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.

Progress

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.

Suggestions:

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.

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. 

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

Yay Team!

At the risk of sounding like one of the Borg collective from Star Trek Star Trek: The Next Generation, I was 6 of 17. One of a diverse group of people who spoke at the Afrezza ADCOM meeting.

It was an interesting day. It overstate things, possibly wildly, but I’ll describe the day as MannKind spoke about the wonders of their insulin and FDA showered upon it a lack of love. Pubic speakers talked of a need for options. The panel considered risk, patient needs and in what the called a difficult choice voted almost unanimously for the drug. 

I don’t know what FDA will do, approve it or not. They have to July 15.  

I do know that those who spoke with me were a fascinating group that spanned the cross section of the diabetes community.  There were a number of physicians who treat PWDs, CDEs who teach PWDs, ADA and JDRF that represent PWDs, and a mix of type 1, type 2 and type 3 (caregivers) people who live with diabetes.

I have not seen as wide a mix at any previous FDA meeting. Nor I had not seen anything like Manny Hernandez’s video presentation, bringing views into the room from a champion who could not be there physically. He spoke of reactions to the drug at tuDiabetes and estudiabetes. He spoke in Spanish, with subtitles when representing Spanish speaking American. That was an appropriate first in my experience. 

Through the diversity of speaker, the message could not have been clearer if we had sat down and scripted it out. In fact one public speaker commented about that, noting that we had not. 

There is not one best way to manage diabetes. People with diabetes need more options to consider with their health care professionals. 

Doctors and patients should consider care plans that reflect individual lifestyles, fears and aspirations. There is an emotional component to care, some folks are afraid or needles. Some shy away from the stigma of injecting in a restaurant, plane or other public place. Some fear hypoglycemia. Others reached unprecedented control with an ultra fast acting insulin.  

Following the public comments, it seemed that in addition to the critical safety issues, the panel also considered the psycho - social aspect of diabetes self care.  All too often, it seems to me, these are overlooked with words like adherence and compliant.

I hope the panel would have had those discussions without the hour of public comments. In the hand full of these meeting I have attend, that as not been the case, certainly to the extent we saw on April 1. 

I hope this was not some twist of April Fool’s Day fate. I hope that the broad community of physicians, CDEs, Big Advocacy and individual PWDs will continue speak in one voice because more options means better care. 

No doubt, the idea of options will need to be better appreciated by third party payers. We can help. Advocacy, just like good diabetes care, work best with a team, doctors, educators and advocates all working with and for patients. 

Forget the Taxes, FFL Scholarships Application are Due 4/15

OK don't mess with the IRS. I was only kidding. No need to send the black helicopters. 

Monday on DSMA Live 'Rents Lorraine and I chatted with Jeff Hitchcock about all kinds of stuff including Friends for Life (FFL). Go have a listen. At the end we talked about FFL scholarships for families, young adults and adults. The deadline to apply to the Diabetes Scholars Foundation for scholarships to FFL in Orlando is postmarked by APRIL 15th. 

Scholarships cover room and registration (not transportation) for families, young adults (18-24) and adults. Young adults are paired with another young adult in the hotel rooms for support and nighttime safety. 

When it come to FFF, Here is what is important.

Please also make plans to support the

Diabetes Scholars Foundation

Saturday July 5, 2014 as they 

Party Polynesian Style at FFL.