January 23, 2015

FDA permits marketing of first system of mobile medical apps for continuous glucose monitoring

From FDA:

Summary

The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.

Release

The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.
The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows caregivers to a person with diabetes to monitor that individual’s blood sugar levels remotely through a legally marketed device that is available on mobile devices. Devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. The Dexcom Share system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patient’s CGM data.
“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431385.htm

January 22, 2015

Sexy new AP from Medtronic.

That get you attention? Good.

Medtronic is starting to roll out their next step to AP in Australia, and it's got a new look


What's new other than the good looks? Predictive suspend aka it stops delivery of insulin when thinks you are gonna go low. Very groovy. Medtronic calls this "SmartGuard™." I call it another step along the path to better care. 

When the 530G rolled out with Low Glucose Suspend, there was a lot of chatter about calling it AP. A Rose by another name is still progress in my book, and I am excited to see both a new pump form factor and another step to AP come to market. 

Speaking of Roses: Spare A Rose is coming up soon. We all need to join in and help kids around the world who need a hand. Show some love this Valentines Day. 

www.sparearose.org


Study: T2D Therapy With Weekly DPP-4 Inhibitor Feasible

From the news wire:
An investigational weekly DPP-4 inhibitor proved noninferior to daily alogliptin (Nesina) among Japanese patients in a phase III study, researchers reported.
Weekly trelagliptin reduced HbA1c to similar levels as the daily drug, and the difference was below the noninferiority margin of 0.4%, Nobuya Inagaki, MD, PhD, of Kyoto University, and colleagues reported online in the Lancet Diabetes and Endocrinology.

Source: http://www.medpagetoday.com/Endocrinology/Diabetes/49646

January 21, 2015

ADA's Your Rights Blog


ADA has announced the launch of the blog series:Your Rights, One Voice (Diabetes Discrimination Stories) on the American Diabetes Association Blog: DiabetesStopsHere.orgEach month the blog will feature a different story about diabetes discrimination and how the person affected received help after contacting the American Diabetes Association (through our Legal Advocacy Program). 

The first story is about Collin Wadian of Massillon, Ohio, a high-school student who has type 1 diabetes and Down’s syndrome. Read Collin’s story and learn how Collin’s Mom, Joan, now feels that he has the “best and safest possible care when he attends school.”

Look for the Your Rights, One Voice story each month onDiabetesStopsHere.org!

Diabetes Scholarships - Team Type 1

The Team Type 1 Foundation offers a number of scholarship program for eligible collegiate athletes with type 1 diabetes. This year, the Foundation will be awarding more than 20 scholarships totaling more than $50,000 to student-athletes who qualify.
 
The application process is now underway and the deadline for submission is February 19th. More information and a link to the scholarship form is available online at www.teamtype1.org.
 

January 14, 2015

Little Help? YFMV. How about Tweeting @Ford

My sister Terry could use a little friend-of-the-DOC help. She has has two thing going on: one is chemotherapy and the other is a ballet with with Squirrels. Guess which one is tougher? (Hint: Ford is on team Squirrel)

Terry has a Ford Transit Van with wheel chair ramp for her daughter. Apparently, Atlanta Squirrels like the taste of Ford Transit Van wire harnesses as a pre holiday snack. Terry's van has been at the Ford Dealer for month while Ford, Squirrel ally, struggles (possible an excessively active verb choice) to find a wire harness.

Meanwhile Terry is doing Chemo, calling Ford and writing about squirrels on Facebook. Here is her latest followed (by a little ask for some social media help):

Squirrels vs. Vehicles Report
Squirrels have new ally to keep our Ford Transit Connect ramp van off the road. Believe it or not it is the Ford Motor Company. They can't or won't or at least haven't shipped the wiring harness that the dealership needs to fix our vehicle from Turkey (country of origin). 
You may be able to guess whether the customer contact center notified me in a timely manner about whether the part had shipped? You guessed right if you answered that they let a whole week go by before letting me know who was "expediting the case" and that when she called she reported not knowing whether it had shipped or from where it had shipped. But she knew it hadn't arrived. I called her back today to find out what she had learned. After a delay to let her slow system load the Info for she had typed into it earlier in the day, She was trying to determine whether it could be shipped direct to the dealer or if it would have to go through a parts supplier. Where is the manufacturer I asked? She did admit that the part came from Turkey. The van came from Turkey so that was not a surprise but I did express hope (probably not founded in reality) that the part would be shipped individually by air not plopped in to a cargo container bound for Baltimore (no offense Baltimore, but that is the harbor the vans come to and I don't want to wait that long.). When will it ship? Maybe mid-January. When I pointed out that it was already mid-January, she pulled out the old hem and haw. I asked her to call me every day. She said she may not have anything to update every day. I said to call anyway. I asked for the number of her direct supervisor and the number of the Ford exec her department reports to. She would not give me either. But she could ask her supervisor to call me. I said I would get numbers and make contact myself.
For those of you following this saga, recall that today is Wednesday, my cancer Chemo day and I have steroids in me at max level. So instead of feeling sick and unable to lift my head as I had been feeling for the last 6 days, I am in battle mode. 
I needed a contact in Europe. Hqtrs in Germany. Hmm - time zone and language issues. Plant in Turkey - ever worse time zone and language issues. But yea for searching the Internet. I found the Vp of Ford Communication and Public Affairs. he used to work for a newspaper in Detroit. Probably speaks English or at least reads it. He has a Twitter account. So All I had to do was get my own Twitter account and "follow" him, then sent him a call for help mentioning squirrels and part shipping problems, etc in the super short structure of a tweet. Seeing I was allowed to attach a photo, I also sent along a picture of Anne. The only trouble with the photo is that there is a gorilla in the background, not a squirrel. He can use his imagination to convert it to a squirrel. Maybe I should have photo shopped a squirrel in there, but not that advanced.
Skilled relatives and friends with Twitter accounts, would you like to jump into the fray? He is Mark Truby @mtruby. I think I got that right. I will send him some more calls for help. I also called Autumn from the Ford Customer Relationship call center and left a message (because of course she knows it was me and didn't answer) to tell her I was tweeting him.


So YDMV Friends how about sending a Tweet to Mark @mtruby and Ford @Ford. I mean they have all those Squirrels on there side, Terry could use some Tweets on her's. @FordService, @sherylconnelly Futurist for Ford, @jc_enoch N. America Ford Truck PR.

UPDATE: Jan 15. Yay! Ford reached out. Here is hoping they can switch from Team Squirrel. I'll let you know.

January 13, 2015

A Lovely Rant by Ira Hirsh

I started using the acronym YDMV years ago on web boards as a way of responding to individuals who aggressively pushed a single 'RIGHT WAY' of managing diabetes. Some time its was the right pump or meter. Occasionally it was shots vs pumps vs pens. Sometimes it was even this is THE I:C ratio you should use because it work for us perfectly.

I would typically agree making a general point about our family's approach to attention to care without mentioning "RIGHT WAY" and add Your Diabetes May Vary. That way when they disagreed with my way it was covered by the YDMV statement and gave others the same out if they didn't agree with the "Right Way."

I also thought it would be fun if it became a commonly used term on the boards. It did.

Part of the new care shake up in the US is grading doctors based on metrics. (For the record I HATE the word metrics. It is a buzz word typically used by people who substitute a number for thoughtful consideration.) Measures would be great if the metrics aligned with the current ADA treatment recommendation about individualization of targets based on the patient's specific situation. (1) It would be fantastic if there was a measure that identified that caregivers spend the time necessary to find the individual targets and customize goals for each patient.

That ain't how it works. (see I feelings for the word metrics above.)

The new system holds Docs to static levels of HbA1c, LDL-cholesterol, and blood pressure. So if you are the doc and you have a patient who is way out of range and you help decrease variability, lower A1C make progress on LDL and blood pressure it doesn't count. Progress is not the end static measure are. In this model success is a number not behaviors.

Hey Who ever makes this stuff up. YDMV.

All diabetes is a progressive. Succes is adapting and changing to make living with diabetes about life not about numbers.


Dr Ira Hirsch as a lovely rant about this. Have a read.

(1) American Diabetes Association: Glycemic targets. Diabetes Care 2015;38(Suppl 1):S33–S40.

January 8, 2015

Paper on SGLT2 in T1D

Looking at T2 meds for possible improvements in T1 managment seem like a goo idea to me. (So does using T1 devices in T2) Here is a paper on SGLT2. It is a meta analysis (aka looking at and sumarizing existing research).

Link offered here for what is worth:

http://informahealthcare.com/doi/abs/10.1517/13543784.2014.909407

January 5, 2015

Linda Siminerio to chair National Diabetes Education Program

Linda Siminerio, R.N., Ph.D., has been named the new chair of the National Diabetes Education Program (NDEP), a joint program of the National Institutes of Health and the Centers for Disease Control and Prevention. Siminerio is executive director of the Diabetes Institute at the University of Pittsburgh.

http://www.nih.gov/news/health/jan2015/niddk-05.htm

December 1, 2014

Animas® Vibe™ Insulin Pump and CGM FDA Approved

The Vibe has been approved by FDA!


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

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