FDA Approves Medtronic Low Glucose Suspend
"MINNEAPOLIS – September 27, 2013 –Medtronic, Inc. (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) approval of the MiniMed® 530G with Enlite®, a breakthrough, first-generation artificial pancreas system with Threshold Suspend..."
Read the rest of this exciting press release at the link.
What is StripSafely?
StripSafely is the initiative to bring awareness to the issue of test strip accuracy. I'm hoping to help bring attention to the StripSafely efforts by helping to make you an advocate for the cause. You are not being asked to make a donation.
If you could just take a moment to read more about the efforts and then follow StripSafely on FaceBook, Twitter and on their website, you'll be supporting people who I completely trust to help the diabetes community have a voice in the fight to change the current levels of accuracy acceptability. I am not affiliated with StripSafely.
Issue - From the StripSafely website:
At a recent public meeting the FDA acknowledged1 that there are some 510(k) cleared blood glucose (BG) meters and strips that do not meet the accuracy standards for which they were approved. There is currently no clear course of action to insure people with diabetes are using blood glucose strips that meet regulatory requirements.
The rest of this statement can be found at this link.
Who, What, How?
StripSafely is an ad hoc Diabetes Online Community (DOC) collaboration to help the general public understand that there are inaccurate blood glucose test strips. We hope to get folks involved to do something about that. By something, we mean write the FDA, elected officials, and the news media.
The StripSafely campaign was created by Bennet Dunlap who is the site admin. Scott Johnson, Christel Marchand Aprigliano, Kerri Sparling, Cherise Shockley and Kelly Close joined early on and contributed their skills. The campaign is not affiliated with strip manufacturers, the FDA, or any other remotely organized group.
The real work of this project is being done by community members who write letters and blog posts as part of this campaign. See the social media section for these efforts. We would love to feature your letters and blog posts. That’s why there is a form on every page’s sidebars to help you share what you have written.
Thank you for taking the time to find out about StripSafely!
Hey FDA, what about diabetes!?
From diaTribe:"The Food and Drug Administration has begun to hold a series of patient meetings to gain a better understanding of specific diseases. Over the next five years, the agency plans to conduct at least 20 such meetings on conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.But not diabetes. That is unacceptable.Four “slots” remain open (view the current list), and we want the FDA to add diabetes to its meeting docket for 2013.According to the American Diabetes Association, nearly 26 million Americans have either type 1 or type 2 diabetes, and an additional 79 million have prediabetes. Those numbers are also increasing each year – the CDC estimates that if current trends continue, one in three US adults will have diabetes by 2050.No one disputes that diabetes is one of America’s – and the world’s – most serious health epidemics. In 2012, more than one in five total US healthcare dollars was spent on diabetes, totaling $245 billion, and the government covered 62% of those costs, meaning everyone is paying for this epidemic. Despite growing needs, research dollars have also leveled off.New therapies need to be investigated, tested, and brought to market, and as part of that process, the FDA must understand the daily challenges that patients face.We need to tell our story to the FDA: about the need for accurate strips, more physiologic insulin, a broader range of drugs, and the Artificial Pancreas.Our voices need to be heard.
Thank you very much."
Join The Strip Safely Tweet-In, August 21st at 8pm EST
Strip Safely is headed by my friend and DOC legend, Bennet Dunlap. In my opinion, when Bennet says something is important for me to pay attention to... it's important. I hope you can send some tweets tonight! - Best, Scott
Taken from www.stripsafely.com
On Wednesday, August 21st beginning at 8pm Eastern, we are staging a StripSafely Tweet-In, asking Congress to send aides to the upcoming Diabetes Technology Meeting on September 9th.
Please join us and add your voice.
We’ve made it easy. Simply go to the Let’s Tweet page of Stripsafely.com, find your state and click the link listed next to your senators and congressmen. We’ve already created the message – you just need to tweet it out. (Don’t forget the leadership at the top of the page – we can all tweet to them!)
Then, please, get creative and send additional positive messages to help the diabetes community build friends in Congress. Include the hash tag #StripSafely. Feel free to use this link to our letter in your tweets.
Diabetes isn’t partisan about whose life it impacts. We shouldn’t be partisan in seeking support for our health.
Insulet Reports 1Q 2013 Results: New Pod Statement
"We are pleased with the initial launch of the new, smaller and lighter OmniPod in the U.S.," said Duane DeSisto, President and Chief Executive Officer of Insulet. "Our customers and healthcare professionals have been sharing their positive feedback about the reduced size, ease of use and change to the insulin on board calculation. Demand for the new OmniPod has been tremendous with referrals and initial shipments up by more than 40% over the last two months as compared to the prior year. In the coming weeks, we expect to begin converting the existing customer base to the new OmniPod and continue to expect the transition to be completed by the end of the third quarter."
The rest of the report is here.
The following is from the May 6, 2013 Insulet Earnings Call. The quote was brought to my attention by the TuDiabetes User, Erik. I then listened to the call to verify the quote as accurate. It can be found 05:47 into the call.
"With this significant uptick in demand, we did make the decision to delay the transition of existing customers for approximately 90 days in order to build additional OmniPod supply. While the manufacturing process continues to improve, we had an unexpected component issue that resulted in lower than planned production in the latter part of Q1. While this component issue was quickly identified, and remedied in conjunction with both Flextronics and the supplier, we determined it most prudent to build inventory and insure that both manufacturing lines were operating efficiently before we commence the transition of over 45 thousand customers to the new OmniPod. At this point, we expect that conversion will start in the next few weeks, and remain confident that nearly all customer will be transitioned by the end of the third quarter."