#TwoBits from Industry. Glucagon Training App and Bayer Meter Talks to Medtronic Pump.

#TwoBits of news today. I use to call this stuff From the News Wire!

Bayer / Medtronic 

Bayer and Medtronic have a press release out today announcing the Contour Next Link.  Think Bayer USB that connects to a Medtronic meter - except this is charcoal grey not black. It uses new, improved and more accurate strips. I hope to read up on the more accurate part at a later date. I will be back when I do. Mean time read Riva.  

Groovy Photo from: http://diabetesselfcare.blogspot.com/

Review of the meter:  http://diabetesselfcare.blogspot.com/2012/04/medtronic-trial-bayer-contour-next-link.html

From the Press Advisory: 

Medtronic, Inc. (NYSE: MDT) and Bayer HealthCare today announced that Bayer’s CONTOUR^® NEXT LINK, a new blood glucose meter, is now available in the U.S. with Medtronic’s compatible integrated diabetes management systems. 
Bayer’s new meter provides exceptional accuracy utilizing high-performance CONTOUR^® NEXT test strips, helping optimize insulin delivery through wireless communication with the MiniMed^® Paradigm™ REAL-Time Revel™ insulin pump and the MiniMed^® Paradigm™ REAL-Time insulin pump. People with diabetes can have greater confidence that seamless integration with Medtronic’s Bolus Wizard^® makes bolus calculations quick and easy, eliminating inaccuracies due to manual entry errors.

This will be available to new Medtronic pump users starting now. The expectation is that existing customers can get it over the "next few months." I think you should look for the Bat Signal or a message from Medtronic in January. 

OK Bat Signal aside - here is the real text from the release:

Starting today, new Medtronic customers will receive CONTOUR^® NEXT LINK with any new pump order. Existing customers will be contacted by Medtronic and provided with new meters over time, beginning in January of 2013.

More from Medtronic:
http://www.loop-blog.com/blog/Update-on-Linking-Blood-Glucose-Meters-for-Medtronic-Insulin-Pumps

Lilly

Lilly Diabetes today announced the release of a new mobile application designed for caregivers and healthcare providers who support people with type 1 diabetes. The Lilly Glucagon Mobile App is a tool to teach how to use Glucagon for Injection, through simulated practice. 

The app is here:

http://itunes.apple.com/us/app/glucagon/id553314007?mt=8

More information is available from the Lilly press release here: 

https://investor.lilly.com/releaseDetail.cfm?ReleaseID=704061

From the News Wire: iPhone App Connects to Glucose Meters

Telcare’s New iPhone App Connects to Glucose Meters Even Oceans Apart:Telcare, the maker of the Telcare BGM cellular enabled blood glucose meter, has released an iPhone app that can gather data from the meter even if they’re physically apart. 

This not only allows you to watch your own glucose, but a parent of a diabetic child can make sure the kid takes regular readings and almost immediately know what the output is.
More

FTNW: Data Standards

Here are a few quick links that help make the case for data standards, not just for diabetes management but in the larger health context. I particularly like this little comment about standards as "a path out of high-cost, locked proprietary systems in the end-to-end ecosystem."

http://www.cmio.net/index.php?option=com_articles&article=27860&publication=56&view=portals

http://www.technewsdaily.com/biometric-sensor-networks-health-2711/

FTNW: Continua

FTNW for those who don't know but may care, and that is a small small group I am sure, is From The News Wire. My short hand for stuff that may be of interest.


This one is about the Continua Heath Alliance. It is something I keep an eye on as it may be a source of data standardization.

So for my few fellow geeks, here is a link to the latest state of the Alliance bit from Continua.

FTNW: Interoperablity

Ran into this blog post today:

Lack of Interoperability Limits Personal Health Solutions

One of the key recommendations is that the buyers of personal health solutions need to understand and value interoperability, and demand it from vendors.

“The project partners share the belief that if Europe wants to reap the full benefit of personal health systems, health stakeholders must understand the benefits of interoperability, and be empowered to demand those systems from vendors”, says Veli Stroetmann, researcher at Empirica. “Only if there are buyers who demand interoperable systems, vendors will bring them to market.”

 I would to have the option of demanding systems instead of systems being demanded by type 1. Veli, I don't think you get it, that kind of influence exists in discretionary markets, where folks can choose not to use products. Type 1 diabetics don't have the option of not choosing a glucose meter.  

FTNW: Medtronic Research

When Medtronic held their social media summit in April one of the topic of conversation was the wealth of data that the CareLink system creates. An obvious question is how is that data studied and is it open to folks outside the big M.?

Today Medtronic with ADA announced such studies. These are anonymous, hippa compliant uses. You can read more at the ADAlink:
http://www.diabetes.org/for-media/2011/Medtronic-Research-Grant-Release-2011.html

Tolerx Phase 3 Did Not Meet End Points

From The News Wire: Disappointing news for people hoping for a suppression of the autoimmune causes of type 1. I am not a rocket scientist or expert on how any branch pf science progresses so I look forward to reading  what more capable writers have to say. I am sure good friend of the blog Scott Strummello will have enlightening comments when he has had time to get all the facts. In the mean time here is the opening of the recent press statement and a link to the full release. 

Tolerx and GlaxoSmithKline Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint

CAMBRIDGE, Mass. and LONDON, March 11, 2011 /PRNewswire/ -- Tolerx, Inc. and GlaxoSmithKline (GSK) today announced that the Phase 3 DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes.  

Following preliminary review of the data, no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study. Study investigators and regulatory agencies have been notified of the DEFEND-1 study outcome.

FTNW: IV PREP Recall

http://www.fda.gov/Safety/Recalls/ucm239219.htm

http://www.pharmabiz.com/NewsDetails.aspx?aid=61752&sid=2

I don't see any instructions about what to do other than toss the stuff out. Smith didn't have any alternative other than wait. I was told to contact our supplier for a refund.

Smith & Nephew recalls selected lots of IV PREP Antiseptic Wipes from US markets

St. Petersburg, Florida
Tuesday, March 08, 2011, 14:00 Hrs [IST]

Smith & Nephew's Advanced Wound Management division announced a US voluntary nationwide recall of selected lots of IV PREP Antiseptic Wipes (product number 59421200) manufactured for Smith & Nephew by The Triad Group.

This Smith & Nephew recall follows an earlier nationwide recall initiated by The Triad Group for alcohol prep products, pads, wipes and swabs due to concerns about potential microbial contamination with Bacillus cereus. Use of contaminated alcohol prep pads, wipes and swabs could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.

Smith & Nephew has halted all shipments of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. All customers and patients are advised to discontinue use of IV PREP Antiseptic Wipes immediately, as their use could result in localized or systemic infection. All customers should dispose of or return IV PREP Antiseptic Wipes to Smith & Nephew.

Smith & Nephew is advising all distributors and kit packers who utilize IV PREP Antiseptic Wipes as a part of their kit components to discontinue use of IV PREP Antiseptic Wipes immediately, and issue a sub-recall to their customers.

The specific lot numbers involved in the recall are: 9K141, 9K142, 9K143; 0F131; 0F140; 0G249; 0G255, 0G256; 0G259; 0K139, 0K140, 0K141; 0K193; 0M180; 0M216; 1A212, 1A213. IV PREP Antiseptic Wipes represent a small part of Smith & Nephew's overall advanced wound management business.

As a precautionary measure, and out of concern for patient safety, Smith & Nephew contracted an independent laboratory to test all lots of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. The results showed there is no data to suggest that Smith & Nephew's IV PREP Antiseptic Wipes have been compromised. To date, there have been no reported adverse events related to this voluntary recall.

Smith & Nephew is committed to providing customers with high quality, reliable product and has issued this voluntarily recall as a prudent, cautionary and conservative measure to assure patient safety and product performance. Smith & Nephew is working closely with the US Food and Drug Administration (FDA) on this recall.

For preparation of the skin prior to injection or venipuncture. It is flammable, keep away from fire or flame. Do not use with electrocautery procedures. For external use only. Do not use in or near the eyes. Discontinue use if irritation or redness develop. If condition persists for more than 72 hours, consult a physician.

Smith & Nephew is a global medical technology business with global leadership positions in Orthopaedics; including Reconstruction, Trauma and Clinical Therapies; Endoscopy; including Sports Medicine; and Advanced Wound Management. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies.

FTNW: Needle-free diabetes testing

I have seen various reports on light based glucose testing and one rather extensive bit on why it will be very difficult if even possible. That said it is still in the news and here is the latest from

A new device based on Raman spectroscopy has been developed by scientists at MIT to help patients with diabetes monitor their blood glucose levels without needing to prick their fingers to take a blood sample...

..."The new device based on Raman spectroscopy is currently under development and we hope to have a functional prototype in the next two years," Barman told SpectroscopyNOW. "However, at this time, we have a portable instrument, which is relatively large, the size of a shopping cart, and can only be used for clinical studies. In fact, our feasibility studies which will start this Fall will be making use of this portable instrument that can be wheeled into a clinic but cannot be used for personal use."

"We will be starting [clinical] studies in September 2010," Barman told us. "We expect the initial series of studies to complete by the middle of next year. In the first trials, we will be testing our instrumentation and methodologies on healthy human volunteers. In the next set of investigations, we will be incorporating our primary target population of Type I and II diabetics. For our purposes, there is no difference between any diabetic patient (Type I, II or gestational) - however, if successfully implemented our technology would be most beneficial to Type I patients who need to perform 6-12 measurements per day."

More at http://www.blogger.com/post-create.g?blogID=9076190155284676524

FTNW: Diamyd Agreement Approval

Diamyd Agreement Receives Antitrust Clearance

Diamyd Medical AB has received antitrust clearance that closes the transaction announced on June 22, 2010 with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company. 

The US Federal Trade Commission's clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act is regarding the agreement between Diamyd and OMJPI for development and world-wide commercialization of the GAD65 antigen-based therapy (Diamyd®) for the treatment and prevention of type 1 diabetes and associated conditions.  

http://www.diamyd.com/docs/pressClip.aspx?section=investor&ClipID=503738

FTNW: To Strip or Not to Strip

That is the Question for non insulin using type 2s in Ontario.

From the News Wire: A recent study published in the Canadian Medical Association Journal challenges the need for self testing of non insulin using type 2s. The idea is that multiple daily test of BG of seniors with type 2, who are not on insulin, doesn’t produce actionable information as there is little rish of hypos. Testing may just create stress. The cost of strips is substantial and the report suggest the resources would be better spent on other T2 care alternatives.

None of this applies to T1 or insulin using T2s who risk hypos from injected insulin.

YDMV who would have thought it?

http://www.google.com/hostednews/canadianpress/article/ALeqM5gKgjmhG7ZVn8J-fUL5FhXrpI2NAw