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spike

MM gets FDA approval for CGMS!

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spike

Medtronic Receives FDA Approval for World's First Insulin Pump with Real-Time Continuous Glucose Monitoring

 

MiniMed Paradigm® REAL-Time System Allows Patients to Make Immediate Diabetes Management Decisions; Marks Major Step Toward an Artificial Pancreas

 

 

 

 

MINNEAPOLIS — April 13, 2006 — Medtronic, Inc. (NYSE: MDT) today announced FDA approval of the MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System, a progressive new therapy available for patients who use insulin to treat diabetes. For the first time in the history of diabetes management, an insulin pump integrates with REAL-Time continuous glucose monitoring (CGM). This new technology will help patients take immediate corrective or preventive action to maintain healthy glucose levels and delay or prevent diabetes-related complications, including coma, blindness, kidney failure, amputation, impotence, and heart disease.

 

The MiniMed Paradigm REAL-Time System is made up of two components, a REAL-Time Continuous Glucose Monitoring (CGM) System, and a MiniMed Paradigm insulin pump. The REAL-Time CGM System relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays to 288 readings a day – nearly 100 times more information than three daily fingersticks. REAL-Time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory fingerstick. The REAL-Time CGM System component is indicated for any patient 18 years of age or older, and insulin pump therapy for all patients requiring insulin.

 

“The approval of the MiniMed Paradigm REAL-Time System opens the door to the next generation of diabetes management,” said Robert Guezuraga, president, Medtronic Diabetes. “As this is the first integrated insulin pump and continuous glucose monitoring system ever approved, we feel this new therapy will revolutionize the way patients manage their diabetes and will improve their lives.”

 

Integrating an insulin pump with REAL-Time CGM is a major step toward the development of a “closed-loop” insulin delivery system that may one day mimic some functions of the human pancreas. Medtronic is testing future systems that would employ advanced scientific algorithms to proactively recommend insulin dosages to patients. Through this process, Medtronic anticipates developing an external, closed-loop system designed to simplify and improve patient diabetes management.

 

The MiniMed Paradigm REAL-Time System’s continuous glucose sensor is a tiny electrode that is inserted under the skin using the Sen-Serter®, a small device that patients or their caregivers can use at home to make sensor insertion easier. The sensor measures glucose in the interstitial fluid found between the body’s cells, and is typically discarded and replaced after three days of use. Glucose measurements obtained by the sensor are relayed every five minutes from a transmitter to the insulin pump, which displays the glucose value, three-hour and 24-hour trend graphs, as well as arrows to indicate how quickly glucose is moving up or down. In addition, an alarm alerts patients when glucose levels become too high or too low.

 

The MiniMed Paradigm REAL-Time System includes a “smart” MiniMed Paradigm insulin pump, which has a powerful built-in Bolus Wizard® calculator to manage the complex diabetes math for patients. Smart insulin pumps recommend insulin dosages after considering the amount of insulin still “active” in the body, helping patients avoid dangerous hypoglycemic episodes caused when too much insulin is delivered.

 

Current standards for assessing glucose control include A1C tests and fingerstick measurements, yet both have limitations. An A1C test, which measures glucose control over a three-month period, is important for long-term management, but it is only an average and does not reveal day-to-day glucose fluctuations that can damage the body. In turn, fingerstick measurements only reveal a glucose value at a single moment in time. As a result, patients are unable to detect approximately 60 percent of low glucose (hypoglycemia) events, and have difficulty assessing glucose fluctuations while they sleep. In contrast, REAL-Time CGM allows patients to view glucose trends throughout the day and night, and understand how fast, and in what direction, their glucose levels are heading. By discovering how diet, exercise, medication and lifestyle affect their glucose levels, patients can make more informed self-management decisions and achieve a greater sense of confidence when managing their disease.

 

About Insulin Pump Therapy

An insulin pump is a small pager-size device that delivers insulin around the clock, much like a healthy pancreas. It is the most advanced method for precise and adjustable insulin delivery. Unlike injection therapy, insulin pump users can program their insulin pump to deliver insulin at varying rates to meet their changing insulin needs throughout the day and night. In addition, insulin can be delivered on demand at the touch of a few buttons. Many patients experience improved quality of life with insulin pump therapy, ridding themselves of multiple injections, strict meal schedules and rigid sleep patterns that are associated with injection therapy.

 

Diabetes Statistics

According to the American Diabetes Association, almost 21 million Americans (seven percent of the population) have the disease. Diabetes affects children and adults, costing the United States more than $132 billion in direct and indirect costs.

 

About Medtronic Diabetes

Medtronic Diabetes (http://www.minimed.com) is the world leader in insulin pump therapy and continuous glucose monitoring. The company’s products include external insulin pumps, continuous glucose monitoring systems and related disposable products.

 

About Medtronic

Medtronic, Inc. (http://www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology, alleviating pain, restoring health and extending life for millions of people around the world.

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JediSkipdogg

Here is some more info on it...

 

http://www.minimed.com/products/insulinpumps/realtime/index.html

 

And currently it's only recommended for those 18 and up. Also, the cost is well, HIGH.

 

It says insurance companies will approve the pump half of the unit. ANd that is available now. However, the CGMS half is still not available and will not be shipping till summer 2006.

 

For new customers who purchased a MiniMed Paradigm® 515, 715, 522, or 722 insulin pump between April 10, 2006 and June 19, 2006 they will be eligible for the step-up program. If you fall outside of that area, it appears you have to buy an entirely new pump.

 

The key part is, for 10 sensors plus the transmitter unit, it will cost $999. That's a little pricey in my blood to be paying out of pocket.

 

Here is the link for the "step it up" program. http://www.minimed.com/stepitup/

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JediSkipdogg

Here is some more info on the starter kit.

 

For a single price of $999, you will receive:

~A transmitter

~A 10-pack of glucose sensors

~A new MiniMed Paradigm 522 or 722 insulin pump, in exchange for your MiniMed Paradigm 515 or 715 insulin pump (if purchased between 04/10/06 and 06/19/06). Orders must be placed by August 31, 2006, for this item to be included.

 

Also, the step it up is a CASH ONLY ITEM and must be paid IN FULL at the time of ordering. They say currently no insurance will cover the item. You also need a prescription for the item and can't order until they have the prescription on file.

 

 

After June 19, 2006, the Pathway program will be eligible for the new pump. However it says a "new" pathway program. Not sure what they mean by that.

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spike
Here is some more info on it...

 

http://www.minimed.com/products/insulinpumps/realtime/index.html

 

And currently it's only recommended for those 18 and up. Also, the cost is well, HIGH.

 

It says insurance companies will approve the pump half of the unit. ANd that is available now. However, the CGMS half is still not available and will not be shipping till summer 2006.

 

For new customers who purchased a MiniMed Paradigm® 515, 715, 522, or 722 insulin pump between April 10, 2006 and June 19, 2006 they will be eligible for the step-up program. If you fall outside of that area, it appears you have to buy an entirely new pump.

 

The key part is, for 10 sensors plus the transmitter unit, it will cost $999. That's a little pricey in my blood to be paying out of pocket.

 

Here is the link for the "step it up" program. http://www.minimed.com/stepitup/

 

There's so much to wear, I wonder where a small child could accomodate so much hardware?

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JediSkipdogg

Well, I doubt many insurance companies will approve it (when they finally do) for children since Minimed makes this statement: "The REAL-Time glucose monitoring component is indicated for adults, age 18 and over, with type 1 and type 2 diabetes."

 

I am amazed though that they didn't spend more time making a smaller sensor. Both the Dexcom and the Navigator have sensors build into the infusion set and not much larger than a current infusion set.

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spike
Well, I doubt many insurance companies will approve it (when they finally do) for children since Minimed makes this statement: "The REAL-Time glucose monitoring component is indicated for adults, age 18 and over, with type 1 and type 2 diabetes."

 

I am amazed though that they didn't spend more time making a smaller sensor. Both the Dexcom and the Navigator have sensors build into the infusion set and not much larger than a current infusion set.

 

 

Did you mis-speak when you said "infusion" set? :) The Navigator is ONLY a CGMS. No insulin pump. Same for the Dexcom, right?

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JediSkipdogg
Did you mis-speak when you said "infusion" set? :) The Navigator is ONLY a CGMS. No insulin pump. Same for the Dexcom, right?

 

Isn't it still considered an infusion device since it's implanted under the skin?

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spike
Isn't it still considered an infusion device since it's implanted under the skin?

 

It is a "sensor". "Infusion" refers to fluid entering the body.

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Shotokan

For new customers who purchased a MiniMed Paradigm® 515, 715, 522, or 722 insulin pump between April 10, 2006 and June 19, 2006 they will be eligible for the step-up program. If you fall outside of that area, it appears you have to buy an entirely new pump.

 

That stinks for MM 515 and 715 users who bought their pumps before April 10. It seems to me that MM more or less promised their Paradigm users a low-cost upgrade to new versions.

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JediSkipdogg
That stinks for MM 515 and 715 users who bought their pumps before April 10. It seems to me that MM more or less promised their Paradigm users a low-cost upgrade to new versions.

 

I agree on that since they've been "selling" it to some customers for the last few months. And the other part is if you are eligible for it (meaning you own a 515/715 bought in those dates), you have to upgrade it before August 31 to get the 522/722 included in the $999 starter kit.

 

I highly doubt insurance companies will start covering it by then, so you have to fork the $999 out of your own pocket. Whereas those that wait, may have a chance of getting it all paid for including the pump upgrade.

 

Plus nobody really knows what the "new" Paridigm Pathway program will be. It may be a better deal and insurance may pay for it.

 

Again, to me, it seems like the device is premature for costs and it's too late for those it promised too.

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jeggeman31

I don't know that I would want to wear all that. heck I get tired of the pump from time to time, hate to think about having to put something else on.

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Tony
That stinks for MM 515 and 715 users who bought their pumps before April 10. It seems to me that MM more or less promised their Paradigm users a low-cost upgrade to new versions.

 

I just spoke with a MM rep. and she said for the people who has purchased the paradigm pump before Apirl 10. Will need to upgrade through the pathway program.

 

For the people that will be upgrading through the pathway program can do so on line June 19.(I think she said)

 

The step it up program is for the people who purchased Paradigm 515 or 715 insulin pump between April 10 and June 19, 2006 and their kit will be shipped on June 19. The step it up program is just a preorder for the new pumpers.

 

As for the $999. for the kit you are also getting a newer pump, which through the pathway program has cost $300 in the past to upgrade to a newer pump. If you want to look at it that way, the transmitter is $350 and the 10-pack of sensors are $350. The sensors are $35 each. No matter how you break it down it is still alot of money for real time readings.

 

Also I think the transmitter needs to be replaced once a year.

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spike
I just spoke with a MM rep. and she said for the people who has purchased the paradigm pump before Apirl 10. Will need to upgrade through the pathway program.

 

For the people that will be upgrading through the pathway program can do so on line June 19.(I think she said)

 

The step it up program is for the people who purchased Paradigm 515 or 715 insulin pump between April 10 and June 19, 2006 and their kit will be shipped on June 19. The step it up program is just a preorder for the new pumpers.

 

As for the $999. for the kit you are also getting a newer pump, which through the pathway program has cost $300 in the past to upgrade to a newer pump. If you want to look at it that way, the transmitter is $350 and the 10-pack of sensors are $350. The sensors are $35 each. No matter how you break it down it is still alot of money for real time readings.

 

Also I think the transmitter needs to be replaced once a year.

 

That's essentially the info I got this AM from MM. that leaves me out in the cold, as my 515 went out of warranty last month. thank, MM!

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Tony
That's essentially the info I got this AM from MM. that leaves me out in the cold, as my 515 went out of warranty last month. thank, MM!
Why can't you upgrade through the pathway program?

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JediSkipdogg
Why can't you upgrade through the pathway program?

 

You still have to have warranty with the Pathway program. The warranty lasts from when your first pump in the program warranty starts. So if you upgraded to a new pump with the Pathway when your 508 is on it's last day or warranty, your warranty on the new pump will expire the day you order it.

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Tony

That is kind of what I thought. After having the same pump for 4 years wouldn't you want to upgrade anyway?

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JediSkipdogg
That is kind of what I thought. After having the same pump for 4 years wouldn't you want to upgrade anyway?

 

The thing I never really understood is the purpose of the Pathway program. It would be like Ford saying you can buy a car from them tomorrow, and the warranty will start tomorrow. Then for 10% of a new car price, you can upgrade your car anytime, but stay on the original factory warranty of the one you buy tomorrow.

 

I think some like the Pathway because it allows them to try new pumps. But to me I'll just wait 3-4 years and get a new one through my insurance company and only have to pay the deductible and at least be guaranteed a full warranty all the time. Since out of warranty pump replacements (if you don't have a backup) are VERY expensive. I think the next day air shipping alone both ways can get you near $100 since you MUST insure the item for $5000.

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Shotokan

Apparently not, Cyborg:

 

REAL-Time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory fingerstick.

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JediSkipdogg
Is the MM CGMS FDA approved to replace fingersticks?

 

Apparently not, Cyborg:

 

REAL-Time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory fingerstick.

 

And that is the catch right there of why insurance companies most likely won't approve of it for some time. Why would they want to dish out more money each year when they still have to dish out hundreds on BG testing supplies.

 

The problem is though, that line is what granted it FDA approval, by requiring confirmation fingersticks. The interesting part will be how many do you think will truely do that? At first alot may, but I can guarantee you teens will use 365*2 chemstrips in a year and that's it. Adults may start off better, but they will slowly rely more and more on the machine for accurate numbers (assuming they build trust in it.)

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Cyborg
The interesting part will be how many do you think will truely do that?

 

Well, I'm connected to a CGMS right now and I don't trust it yet...

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