Medtronic Receives FDA approval for new integrated system for diabetes management

This just in.

Next Generation Integrated System - MiniMed Paradigm® REAL-Time Revel™ System - Incorporates Predictive Alerts to Help Patients More Tightly Control Diabetes

MINNEAPOLIS - March 17, 2010 - Medtronic, Inc. (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the MiniMed Paradigm® REAL-Time Revel™ System, the next generation of the industry’s only integrated diabetes management system (insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software). The system incorporates new innovative CGM features including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events.

“Medtronic is extending its lead in the path towards the artificial pancreas with this next generation integrated system and our ongoing advancements in algorithm development,” said Katie Szyman, president of the Diabetes business and senior vice president at Medtronic. "We are excited to make these leading innovations available to improve patients’ lives with the industry’s only integrated system in the world today. The MiniMed Paradigm Revel System can help a patient feel more secure by giving early warning of one of their greatest concerns, hypoglycemia, while continuing to simplify the complexity of diabetes management with easy-to-use features."

When using Medtronic’s glucose sensors with Paradigm Revel Insulin Pumps, trend alerts can notify patients of rapid changes in glucose levels so that they can take immediate corrective or preventative action after confirming glucose levels with a fingerstick glucose measurement. Several new CGM features, including predictive and rate of change alerts, provide earlier warnings of potential glycemic excursions to help patients stay in their target range. According to recent internal study, the use of predictive alerts improved hypoglycemic event detection by 36% compared to the standard low glucose alert. All alerts can be customized to suit a patient’s lifestyle, such as creating different settings to accommodate for exercise or to manage nocturnal hypoglycemia.

New features in the insulin pump enable patients to tailor insulin delivery to meet their personal needs. Patients who are sensitive to insulin, such as children with diabetes, now have the opportunity to deliver insulin in smaller increments (0.025 units per hour.) In addition, insulin-using type 2 patients, who are often more insulin resistant, can more tightly control their glucose levels using the new 1:1 carbohydrate ratio. The system also enables patients to set up missed meal bolus reminders.

“Recent clinical evidence clearly supports that insulin pump therapy combined with continuous glucose monitoring improves patients’ A1C while reducing the relative risk of severe hypoglycemia,” said William Tamborlane, M.D., professor of pediatrics and chief of pediatric endocrinology at Yale University School of Medicine. "Advances such as predictive alerts and smaller basal delivery rates can help physicians and patients customize therapy to meet individual needs. This ultimately simplifies some of the complexity of daily diabetes management."

There is a growing body of clinical evidence that continues to prove that the more often patients use Personal CGM, the greater average glucose control (A1C) they can achieve without increasing hypoglycemia, including the JDRF-Funded Studies and REAL TREND Study. Today, insulin pumps are covered by nearly all commercial and government insurance programs in the United States, and nearly 90 percent of type 1 diabetes patients with commercial insurance coverage have access to CGM when medical criteria is met. Personal CGM is approved for use by people ages 7 and older in the United States.

so, it looks like they are integrating some features from the Deltec CoZmo, like the missed meal bolus reminder, one of the things i miss from my old Deltec pump.

Hmmm, might have to look into the new features of this pump since my 712 is out of warranty.

Is this the same unit as the one that has been out in Europe for a while? The one that will shut off insulin delivery if you go too low?

Um, I don’t get it, it’s only marginally different from my CGM+Paradigm 522 - which already has high/low alerts. It doesn’t have rapid change alerts, but since those are almost never real, who cares?
smaller basal delivery rates? The rate is smaller - that’s a square wave, or a longer bolus rate, they’ve been going that way. I do notice my absorption is better for a 30 min square wave than a bolus, but still, this is a marginal change.
This isn’t really anything special, or what am I missing?

A huge marketing push by MM for their utterly useless CGM. Dexcom CGM already has alerts for rapid rise and rapid fall rates. Until MM makes a CGM that’s at least as reliable and as pain-free as the Dexcom 7+, I’ll pass on anything that MM tries to push.

For someone on the Minimed integrated system, these changes are great. I don’t want to have to switch to DexCom to get DexCom’s features. If those features are so great, then clearly Minimed should have them to stay competitive.

Having .025 units for basal and bolus is ideal for children who take such little insulin, and so far has been a competitive advantage for Animas, hence Minimed’s integration of that feature. Also, I find my trends to be valuable, but I don’t usually know about it until I’ve hit my threshold. However, since my BG is usually different (read: higher) than what the pump says I am, I’m usually getting that alarm a little late. If I knew I was trending upward before I hit my threshold, I would know to test and correct earlier. I would also be able to keep my eye on it more closely, IMO. I have been asking for predicative alarms for awhile, and I’m so glad they have them now. It’s something DexCom has and Minimed should have them too!

Absolutely! I was speaking only for myself and others here on the forums who have had a terrible experience with the MM CGMS.

i talked to a sales rep at minimed earlier. the only difference between the Revel system and the Vio (i think that’s what it’s called, it’s the current european model) is that the low glucose shutoff feature will not be present on the Revel pump when it starts shipping in 2 weeks

yeah, i was considering a switch to the dexcom for these features, but now i guess i’ll stick with the minimed

I have not had the greatest luck with the Minimed sensor either. I think some of these features will help with my troublespots with the system and I’m looking forward to seeing how it all works. Amy’s blog also said that the controlling algorithm is stronger for added protection at catching hypos, which is also something I had probs with (I was always low before the CGM caught my lows). We shall see how it turns out.

I have found that with the MM system, you have to calibrate when the isig ratio ( bg divided by isig) is close to 8. If it is a double digit number and you calibrate anyway, then the following numbers are worthless. And I almost never see the arrows for rising blood sugars, wHich is why I got the CGMS: to catch the high before it gets there. I can feel my lows, no hypounawareness here…My problem is that the sensors, when properly calibrated, will catch a low that I I new was coming anyway; They almost never “catch” a high by alarming… I have never seen the double arrows go up, and only three or four times have seen a single arrow go up or down. Maybe it is because I rise and fall slowly, which I guess is a good thing…It does help if I look at it as a trend revealer…so If I see it creeping up,( or down) I know to check and correct as needed…The brand -new printed guide to the MM system says to not really rely on the individual numbers, but count on the “trends” so that’s what I do. It has helped me to bolus more accurately for certain types of meals, such as high fat combined with carb.

God Bless,

Rewrite of the software has been a long time in coming to the paradigm system. The low and high and the rapid warnings are a BIG deal if you want to get the most out of the CGM.

I’m ready to upgrade after reading the new features because the changes fix several of the weaknesses I see in the current software on my 522.

I would also like to speak for myself… as someone who has used MM. Medtronic, for being the “leader” in diabetes management (and having the most money, by far, in the industry) sure is slow to make changes and take any steps forward. (and I do NOT count this as a large step forward). Thanks Manny for keeping us updated, regardless of how we all respond to it.

I must admit …I almost think , I have read this story before …no changes as far as I understand …OR are we ahead in Canada ?? Maybe I need to " see " , rather than " read " …I’'ll forward the link to MM Canada and ask for their explanation .

Speaking for yourself is fine. I have to admit that it is a funky system if you do not learn how to calibrate it. I’ve had the opportunity to used several CGMs at the same time side by side, new and old, from MM and Abbott. The big difference between the systems is the software so better software may be really BIG deal.

I have not had a chance to use the DexCom to date.

It was just released today, have you seen it?

wHich is why I got the CGMS: to catch the high before it gets there. I can feel my lows, no hypounawareness here…

Me too! I wanted to catch my highs before I was high, but all the CGM does is tell me when I’m already there. I obviously catch them pretty early, but I would rather not ever go high than to be alerted I’m high before I drink a gallon of water. I mean, who wants to constantly be watching the sensor like a hawk? I don’t. I’m curious to see if this will help.

For me the MM CGMS is changing the way I manage my condition and my life. It has been the most profound bit of technology I have used in 20 years and I develop and use technology for a living.

I am sorry you have not been successful with the MM CGMS but to say it is useless is, IMO, silly.

Try the Dex…I keep my abdomen for the pump exclusively but I use my thighs for the CGM. And the Dex is so thin and painless that you can’t even tell where you inserted it a day after you remove the CGM - no bullet holes. Seriously, at least give it a trial and see for yourself how useful a CGM really can be for controlling diabetes. Don’t give up on CGM based on it not being integrated into your pump.