Animas Vibe, First CGM-enabled, waterproof insulin pump system now approved in Europe

Just got this press release. It's a BIG deal! Hope everyone around the world will soon be able to benefit from this kind of advance.

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WEST CHESTER, Pa., June 2, 2011 – Animas Corporation announced today the receipt of CE Mark approval for Animas® Vibe™, the first and only continuous glucose monitoring (CGM)-enabled insulin pump system with Dexcom G4™ CGM technology. Animas® Vibe™ brings together the unique features of an Animas® insulin pump and the convenience of Dexcom CGM, which is the only sensor approved for up to seven days of wear.

As a CGM-enabled system, the Animas® Vibe™ insulin pump functions as a receiver for the Dexcom G4™ Sensor. The system delivers real-time glucose information, alerts for high and low readings, and glucose trend information, enabling patients to make more informed decisions to help control their disease*. Unlike currently available CGM-enabled pump systems, Animas® Vibe™ displays glucose trends in colour and is waterproof.**

“The CE Mark approval for Animas® Vibe™ is a significant milestone for our R&D program and for people living with diabetes who are seeking better ways to manage their disease,” said Henry Anhalt, D.O., Chief Medical Officer, Animas Corporation. “Avoiding extreme highs and lows in glucose levels is crucial to controlling diabetes and reducing the risk of long-term diabetes complications. Animas® Vibe™ brings together leading pump and CGM technology to provide more freedom and flexibility to people living with diabetes.”

Clinical studies have shown that adults ages 25 and older with type 1 diabetes who use CGM therapy to help manage their disease often experience significant improvements in glucose control.1 Furthermore, patients who use insulin pump therapy in combination with CGM obtain lower HbA1c levels relative to baseline and relative to patients who use multiple daily injections and self-monitoring of blood glucose.2

CGM-enabled systems, like Animas® Vibe™, provide patients with a more complete glucose picture (compared to fingersticks alone) – including customizable high and low alerts and rate-of-change alarms and trends. These features allow patients to make more informed decisions to help control their disease.*

“Diabetes is a demanding disease. Companies like Dexcom and Animas work tirelessly to provide people living with diabetes relief in the day-to-day, hour-by-hour management that is required with this chronic condition,” said Dr. Anhalt. “By combining high-performance pumping with state-of-the-art CGM technology, we’re able to bring people with diabetes tools to better manage their disease.”

Animas® Vibe™ marks the first integrated product offering from Animas Corporation, makers of high-performance insulin pump technology and Dexcom, Inc., the leader in continuous glucose sensing technologies. Now approved in Europe, the product will initially be available to people living with diabetes in the United Kingdom, Germany, France, Italy and Sweden.

Animas® Vibe™ offers:
  • The latest technology available from Dexcom – Dexcom G4™, a tiny, round and flexible sensor with the smallest introducer needle as compared to Abbott Freestyle Navigator® and Medtronic Sof-Sensor®
  • Advanced high-contrast colour pump screen technology, that displays glucose trends with coloured arrows and lines showing where and how fast glucose levels are shifting
  • Dexcom sensor technology approved for up to seven days of wear, delivering more days of CGM data than those approved for a shorter duration
  • Waterproof durability up to 12 feet (3.6 metres) for 24 hours for the insulin pump, with a Dexcom G4™ Transmitter that is waterproof at 8 feet (2.4 metres) for 24 hours
  • Customizable alarms to indicate high and low glucose levels including a hypo-safety alarm fixed at 55 mg/dL (3.1mmol/L)
  • Low basal increment (0.025 U/hr) across all available ranges (0.025 U/hr to 25.00 U/hr) for precise dosing
  • Compatibility with Diasend® communications software, enabling patients to store, review and print both CGM and insulin pump data

About Animas Corporation
As part of the Johnson & Johnson Family of Companies, Animas is dedicated to creating a world without limits for people with diabetes through a wide range of products, including Animas® Vibe™, the OneTouch® Ping® Glucose Management System, and the Animas® 2020 insulin pump. Animas, from the Latin word meaning “true inner self or soul,” has been committed since 1996 to meeting individual patient needs through the development of life-performance technology and customer service 24 hours a day, 7 days a week, 365 days a year. To learn more about Animas, visit http://www.animascorp.co.uk/

Tags: Europe, animas, announcement, approval, vibe

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I have the same wishes for a remote. I, too, find it difficult to read. Sometimes I can't tell a 6 from an 8. I do use it though, it's already in my hand when I do a fingerstick. Not sure if I'll like the extra step of having to enter a BG.

Not much hope as long as they stick with RF though ;\
I chatted with a Dexcom product development guy at the San Diego Tour de Cure. While he wouldn't be specific, he said the G4 was a huge step above current version. Just tantalizing enough to make me salivate.


So I wonder, is Animas going to offer upgrade program for Vibe in Europe (I guess in the US there was a possibility upgrade 2020 to Ping for 200$).
Here is a web post in regards to your request

"If you commence pump therapy on an AnimasR 2020 between now and the launch
of our next
product (expected in the first half of 2011), the ezAccess Programme allows
you to upgrade to
the latest technology free of charge.
Receive the AnimasR 2020 insulin pump now and you will receive a free*
upgrade
to Animas' latest pump when it becomes available.
For further details contact your Animas Territory Manager or contact us at
0800 055 6606 (UK) 1800 812 715 (Ireland)

* Free of charge upgrade is for insulin pump only. The ezAccess Programme is
only available for patients whose Animas pump's warranty period commenced
after 1st March 2011. The warranty period of your current insulin pump will
apply to the upgraded pump you receive through the ezAccess Programme.
Pricing, terms and conditions for the AnimasR ezAccess Upgrade Programme are
subject to change, at any time, without notice. Your AnimasR 2020 insulin
pump must be returned to Animas Uk/Ireland upon upgrade to the new pump.
Programme is only available for UK/Ireland customers. Offer expires when the
new pump is made available within the UK/Ireland. The ezAccess upgrade
programme is not available to patients under the age of 18, as our next
product will not have an indication for patients under the age of 18 at time
of launch. Offer must be
redeemed by 31st December 2011."

http://www.insulin-pumpers.org/mail/archive/mail-ip-united-kingdom/...
Hi! Thanks for the info! This sentence "The ezAccess upgrade
programme is not available to patients under the age of 18, as our next
product will not have an indication for patients under the age of 18 at time
of launch." nails it for us...
I only just got My Ping, but I would change to this new one in a heartbeat! Please let it come to Canada soon!
I wear the Animas 2020 (love it) and I am new to the Dexcom7 (only on my second sensor, it is simply amazing). I'll be happy when we get the Vibe in the U.S. so I have the two combined, but am not holding my breath. This approval in Europe is truly good news.
So first; This is an exciting product, truly like the fact that cgm is integrated to the system.

But there is this thing that I was wondering; Animas 2020 came in 2007. Vibe in 2011. Is Dexcom CGM integration the only major feature that was developed in 4 years? Is this because of the legislation/FDA complexity?
I'm kind of confused about the set up of this one. Is the CGM part of the insulin-delivering infusion set or is this going to be an extra bit to pop on, that can be monitored by the pump itself? Anyone know?
It'll be similar to the current Dexcom sensor - pop in the sensor, click in the transmitter. Rather than having a separate receiver for the Dexcom info, it will show on the pump. So... one fewer 'thing' to haul around.

I would love to upgrade to this, Govt of Canada dept are slowwwwwww to approve, we need a system like Europe for these types of advances......

Siting here waiting

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