Omnipod DASH Apps are here!
Omnipod DASH Display and VIEW apps are available now for iOS…
The Omnipod VIEW™ app allows users to see the insulin delivery information of friends and loved ones whether they’re in the next room or across the country. Omnipod VIEW™ is an application that allows you to view PDM data and Pod status information from any Podder™ who sends you an invitation. Upon accepting the Podder’s™ invitation, the Viewer can see the Podder’s™ important therapy-related information, such as alerts and alarms, Insulin On Board (IOB), last bolus, last blood glucose reading, current basal program, PDM battery status, and more.
No matter where your Podder™ is, the Omnipod VIEW™ app offers peace of mind by keeping you connected and informed.
“I can’t quite describe how thrilling it is to be able to see my daughter’s Omnipod data on my phone — her IOB, last bolus, basal settings, history, all of it! It’s like having the DASH PDM display right on my phone.”
With the Omnipod VIEW™ app, you can:
• Monitor your Podder’s™ insulin delivery and Omnipod DASH™ System status remotely
• Stay connected on up to 12 Podders™
• Enable notifications to your smartphone about Podder™ status for increased peace of mind
• Use the Omnipod iPhone widget for convenient access to insulin delivery information on the Today View
• Set up the Omnipod VIEW™ app’s iPhone widget next to the Dexcom widget for a quick glance of your Podder’s™ DASH™ PDM and CGM information on a single screen.
Omnipod DISPLAY™ is an application that displays your Omnipod DASH™ System information directly on your iOS smartphone.
Don’t have Omnipod? get a FREE, NO OBLIGATION demo Omnipod sent to your home - try it today!
With the Omnipod DISPLAY™ app, you can:
• Monitor your insulin delivery and Omnipod DASH™ System status conveniently and discreetly from your smartphone.
• Use the Find My PDM feature to quickly locate a misplaced PDM. Note that this feature works within Bluetooth® wireless technology range
• Set up the Omnipod DISPLAY™ app’s iPhone widget next to your Dexcom widget for a quick glance of your DASH™ PDM and CGM information on a single screen.
• Invite up to 12 friends and family members to use the Omnipod VIEW™ application which allows them to view your insulin delivery and Omnipod DASH™ System information on their own smartphones.
Enable Omnipod DASH™ System notifications to your smartphone.
FDA recalls Medtronic 600-series MiniMed insulin pumps
Alert says Medtronic's MiniMed device could malfunction on airplanes
From the Star Tribune: Entire article can be found here
“The problem has long been known. Medtronic first notified patients about the problem in 2017.”
The U.S. Food and Drug Administration is reminding patients who use the popular 600-series MiniMed insulin pumps made by Medtronic that the devices contain an issue that could cause their buttons to get stuck while flying or other situations when air pressure changes quickly.
The FDA on Wednesday issued alerts for more than 189,000 MiniMed insulin pumps worldwide. Such pumps are used by diabetic patients who need a steady infusion of the drug insulin to break down the glucose in their blood, in addition to periodic doses (or "boluses") of insulin related to meals, exercise and other factors.
The alerts issued Wednesday are classified by the FDA as a class 2 recall, which is a medium-severity action used when a problem caused by a medical product would be temporary, or when the probability of serious adverse consequences related to the problem is considered remote.
Medtronic has issued an urgent safety notification to patients, which the FDA calls a "recall." However, FDA and Medtronic are not requesting any devices be returned to the manufacturer. The FDA uses the term "recall" to include situations where no product need be returned.
The recalls apply to MiniMed 670G, 640G, 630G, and 620G models, which have physical keypad buttons that can temporarily become "unresponsive" when atmospheric pressure goes up or down quickly around the pump, typically during takeoff and landing.
Read the entire article here
Podder Talk
Thank you to Omnipod for highlighting the Juicebox Podcast in their Father's Day blog post!
Two Podding parents chat about being bold with insulin, not being a diabetes defense attorney, and creating great content that helps people manage their type 1 diabetes.
Check out Amy’s post and the podcast conversation that we had.
Sanofi Insulin Pricing Program
from press release - 4/10/19
Starting in June, Sanofi will further expand its innovative Insulins Valyou Savings Program so people living with diabetes in the United States can pay $99 to access their Sanofi insulins* with a valid prescription, for up to 10 boxes of pens and/or 10 mL vials per month. The expansion of this program helps to address the challenge too many patients face regarding unpredictable and unaffordable pricing for their insulin.
“People living with diabetes in the United States can pay $99 to access their Sanofi insulins* with a valid prescription, for up to 10 boxes of pens and/or 10 mL vials per month.”
People exposed to high out-of-pocket prices at the pharmacy counter can participate in the Insulins Valyou Savings Program regardless of income level. This includes those who are paying high retail prices for their insulin and those who don't qualify for other patient assistance programs.
Under current government regulations, pharmaceutical companies cannot offer this type of program to patients insured under Medicare, Medicaid, or similar federal or state programs, though Sanofi supports changing rules to expand this access program to all those who might benefit.
For more information or to learn how to access this program, visit www.InsulinsValYOU.com.
Additional patient resources available for accessing Sanofi medicines
Sanofi continues to offer other resources to make insulins more accessible including co-pay cards which may limit out-of-pocket expenses sometimes to $0 for all commercially insured patients regardless of income level. In addition, Sanofi offers assistance programs that provide medications, including insulin, at no charge for qualified low-income, uninsured patients through the patient assistance component of the Sanofi Patient Connection program. Together, these programs demonstrate the company's dedication to finding support to help people living with diabetes gain access to the insulins they need.
Sanofi also encourages anyone who is prescribed a Sanofi medicine who may be having financial challenges or trouble navigating their insurance, to call Sanofi Patient Connection at (888) 847-4877 where eligible patients can be connected to the medicines and resources they need at no cost.
* The Insulins Valyou Savings Program does not include Sanofi's combination insulin product.
The entire press release is available here
Statement from FDA Commissioner on Insulin Pricing
The FDA has issued a statement intended to spur competition and lower prices. I’ve pulled out and included a few passages that are about insulin. You can read the entire statement as written here.
from FDA.gov
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework.
“There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible. Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients.”
We’re going to be monitoring these markets. And we’ll be taking additional actions. We’re actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the U.S., where prices may be cheaper and reference products more accessible.
We’re also releasing today two critical guidance documents that describe how the agency plans to implement Congress’ direction that we transition certain biological products currently approved as drugs under the FD&C Act to be licensed as biologics under the PHSA.
Transitioning these drugs to the PHSA will let them to be treated as biologics under that law. And that means opening them up to competition through the biosimilars pathway. This includes insulin, which has been historically regulated as a drug and not a biologic.
Starting in March 2020, the approved marketing applications for the small subset of “biological products” such as insulin and human growth hormone – which for complex historical reasons were previously generally approved as drugs under section 505 of the FD&C Act – will be deemed to be biologics licenses under section 351 of the PHSA. Sponsors have known about this transition for a decade. They’ve had time to prepare.
“As a result, we’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive. These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.”
Today, we’re laying out our policy on how these products will transition from the drug pathway to the biologics pathway, and in so doing, how we intend to use this new framework to promote competition. The two guidance documents we’re releasing today, one final and one draft, describe how the FDA intends to accomplish the transition of these products under the “Deemed to be a License” provision of the BPCI Act. The final guidance deals with “Interpretation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009,” finalizes the FDA’s draft guidance from 2016.
We’ve shaped these policies to implement the intent of Congress, and to make sure a few things happen. First, that the anti-evergreening provisions under the biosimilars legislation – meant to prevent sponsors from being able to game the exclusivity provisions to forestall biosimilar entry – will apply to these newly deemed products, including insulin.
