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 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

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.  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.


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.