Close Concerns Weblog

JDRF Continuous monitoring trial receives big win - reported in Europe and published in the prestigious New England Journal of Medicine

We were thrilled to see the highly-respected New England Journal of Medicine (NEJM) report on the JDRF continuous glucose monitoring trial results, almost as if the EASD (the major European meeting that took place in Rome all last week) had planned and sanctioned its release! The study was said by many experts to be extremely well designed and executed with results revealing much needed information about glucose sensor optimization. We see it as a positive for patients, doctors, educators, manufacturers of CGM, and payors - despite it being early in the life of the technology, there are some long-term very bright lights here. In the presentation, researchers went into the data in even more detail than the NEJM offered, and voiced some of their opinions and speculations regarding its consequences. The main news was that the A1c drop was statistically significant for adults, whereas children and teens didn’t see a significant A1c benefit – this from our view had to be tied to usage on the device, where adults used the CGM significantly more than kids and teens. Here’s our take:

What is this trial we keep hearing about? It’s a landmark study that for the first time demonstrates that CGM use can clearly lower A1C by a significant month in a six-month time frame. Health insurers and national health services, take note! The investigators anticipated results well and designed accordingly so that each age group was powered a priori for a 0.5% A1c drop. They also understood that CGM success has a significant behavioral component and gave a lot of attention and support to patients. Patients were either sorted into a SMBG group or real-time CGM usage; patients received education in glucose control and users of CGM had additional training on the devices. They could choose from any device (Abbott’s Freestyle Navigator, DexCom, or MiniMed Real-Time CGM) and were free to switch devices throughout the trial. Patients had several follow up clinic visits periodically in addition to phone support follow-ups.

What were the results? There was a significant improvement in what they call both primary and secondary outcomes with CGM use. After the 26 week study, there was a -0.5% decrease in the adult CGM group from baseline of 8.0% and a tiny 0.03% increase in the control group, combining in a highly significant between-group difference of 0.53%. Significant differences were seen for outcomes as well, with 35% of adults in the CGM group reaching a target of 7.0% compared to about 10% in the control group, 25% in CGM versus 5% in the control achieving a relative drop of ≥10%, and 47% versus 10% seeing an absolute drop of ≥0.5%. Results show that 83% of adults in the trial used CGM > 6 days/wk over the entire six months.  We think what led to these results is that adults figured out how to use CGM to get less hyperglycemia and less hypoglycemia.

Side note: Patients were mostly recruited from some of the top diabetes practices in the USA. Dr. Aaron Kowalski of the JDRF said that although the patients were representative of these practices, they were not “otherwise special” and other doctors concur that patients in the trial weren’t ‘special’ since they all had A1c >7%. We believe excellent support given during the trial made a difference on the results – patients received six in person check-ins and scheduled telephone calls between visits. We do think it’s critical that funding increase for doctors and nurses so they can spend time with patients helping them learn this valuable technology.

Additionally, it was good to see that hypoglycemia did not increase in the CGM group – in fact, it decreased in adults while at the same time A1c also decreased. While the hypoglycemia reduction wasn’t “significant,” the trend toward less hypoglycemia was – this is certainly exciting as we at Close Concerns who had diabetes can attest – we love anything that will help us have less hypoglycemia and have certainly used CGM toward that end. Doctors who presented results at EASD said that hypoglycemia is the biggest barrier standing in the way of better A1cs – this has been said for years and finally there is something that can address these barriers.

Other “secondary” (in science lingo) outcomesincluded the percentage of patients achieving an A1c target of 7%, and those achieving a ≥10% relative or ≥0.5% absolute A1c drop, as well as CGM profiles obtained in both groups at three and six months, data about hypoglycemic events, and questionnaires about patients’ quality of life and the costs/benefits of CGM use. We’ll be finding out much more about secondary outcomes as the data is analyzed – and this trial is actually a one-year trial, so there will be key “one-year” results to see.

What are the next steps? There is still much more extensive work to come, including an analysis of hypoglycemia in 120 patients with A1c <7% (already in the target zone), what they call psychosocial factors (think little family-diabetes conflict, ability to access medical care, etc.) and healthcare economics, and the outcome of the follow-on six-month crossover study, when all the patients  use CGM. After the first six months, patients in the CGM group will continue CGM therapy for another six months, and patients in the self-monitoring blood glucose (SMBG) group will be offered CGM therapy for the same period with a less intensive management schedule. This additional period was designed to allow researchers to examine how long CGM works (this is what they call “durability”) and how long positive effects seen with CGM last and to examine whether CGM use is beneficial even without intensive clinical follow-up.

What’s the future of CGM? The bottom line seems to be that some patients do respond to CGM better than others, and that patient motivation, support and improvements in the devices can make a big difference. It turns out that teens and children in the study used the devices much less than adults did – kids only used the devices 51% of the time and young adults 30%).  We aren’t surprised not to see substantial A1c changes if people didn’t use the devices (!) and it just raises the question that now the technology is here, how can it be made easier to use.  

The results seem to point out that there are ‘requirements’ for success of CGM therapy. Most doctors and interpreters of the trial recommend for patients to learn to react to trends (rather than static, exact numbers). Also, patients must be able to call upon their health care team, and members of these teams should start changing their preconceived notions about diabetes and invest the time necessary for optimal use of CGMs. Although both younger groups saw less of an effect than the adult group, there are several predictors of CGM success, mostly surrounding time using the device and psychosocial barriers, that should be addressed (psychosocial barriers to diabetes care should be addressed anyway!). We’re very positive about the future of this important technology and look forward to further trial results in 2009! Congratulations to everyone who worked on this trial and who participated in it – this is just the start !

09/14/2008 in Diabetes - devices | Permalink | Comments (2) | TrackBack (0)

CGM lovers, unite!

So this is very cool. Gina Capone was irritated about not having her CGM reimbursed (absurd, we agree) and so she did something about it. She vaulted a query out there as to whether anyone else was annoyed. And what a groundswell! Turns out there are a lot of us who feel badly about this - click here for her excellent patient petition that has hundreds of signatures already... 

Our own Jim Hirsch wrote in diaTribe about this In Search Of Reimbursement: A CGM Odyssey last year - see the link to this story. Jim took us through the ins and outs of addressing his insurance company - happily, he has had a happier ending than many of the blogs (we've seen over SEVEN!) that have discussed their difficulties in navigating (so to speak) their insurance companies. 
Jim's follow up to the (what seemed like 522 requests!) can be found here at #B027 And Me: An Update On A Reimbursement Odyssey.  

We thank Gina big-time for getting us all organized and reminding us of the vision that anyone with diabetes who needs to improve their glucose management and avoid (costly!) long term microvascular and macrovascular complications should have a chance at this technology and should be able to use it to improve their health and their lives. I've not yet been as lucky as Jim and am still going after my own insurance company (part of me worries I'm going to have to give them 522 requests) ... I personally thought I knew everything involved as part as paperwork went but I couldn't believe the mountains of paperwork required. Yet and still ~ completely worth it. 

And in the meantime, while I'm waiting to hear from Blue Cross / Blue Shield ... we hope that data from the JDRF CGM trial might help us out here sometime soon. Rather than submitting reams of paperwork just like everyone else's paperwork that shows me struggling with highs and lows, I'd much rather point to clinical trial results. Cheers to JDRF for taking on and getting funded such important trial work. Literally any week we hope to be hearing from the JDRF on the outcome of its CGM trial, where patients were randomized to using CGM or not using CGM - we'll see what happens. Trial design and execution is always challenging but we would assume that if there are differences on the hypoglcyemia front and/or A1c front, it will become a heck of a lot easier to be reimbursed.

Things have already started to change. President of Medtronic Diabetes Chris O'Connell noted earlier this summer that as many as half of the Paradigm Real-Time continuous monitoring devices sold are gaining reimbursement, compared to 5% a year earlier. Now that's progress, already. Long may it continue - and thanks to Gina and the JDRF, even come a little faster....

07/15/2008 in Diabetes - devices | Permalink | Comments (1) | TrackBack (0)

When companies talk, symbiosis happens...

When two powerhouses  in their respective fields get together to work towards a common goal,  we have good things to look forward to. Insulet is the company that manufactures the OmniPod, a tubeless, disposable insulin pump – we like to think about it as the “no strings attached” insulin delivery method.   DexCom makes continuous glucose monitoring CGM devices – it is, alongside Medtronic, one of two companies with an FDA approved CGM device.

Continue reading "When companies talk, symbiosis happens..." »

01/17/2008 in Diabetes - devices | Permalink | Comments (1)

Solid Third Quarter 2007 Performance for J&J

In September, Johnson & Johnson’s diabetes franchise, LifesScan/Animas posted its strongest growth quarter since 2005. LifeScan sales of $585 million rose a whopping 16% from last year. This growth is being fueled (unfortunately) by more patients with diabetes and fortunately (we hope) by more patients thinking more about how to use tools like blood glucose monitoring and insulin pumps appropriatley. Note that J&J has a very strong international diabetes business with sales of $264 million, an increase of 17% over a year ago – as we understand it, they are working particularly hard in developing countries, which we think is very good since that is the part of the globe that needs better diabetes care the most. That said – so does that US, where sales were $321 million (up 15% from a year ago.).

Continue reading "Solid Third Quarter 2007 Performance for J&J " »

12/11/2007 in Diabetes - devices | Permalink | Comments (1)

How a Worldwide Diabetes Epidemic Could Be A Good Investment Opportunity

Over the years, we’ve received many mailings that have heralded the next great product in diabetes care, but we recently got one that was unusually lavish: a 12-page, magazine-type supplement, packed with color photographs, ominous data, and screaming headlines. “DIABETES EPIDEMIC OUT OF CONTROL,” blared the front page.

The advertisement focuses on the marvels of a new “wireless” glucose monitor (GlucoTel), but the promotion itself doesn’t try to convince readers to buy the product. Rather, its goal is to persuade them to buy the stock of the company that makes the meter (BodyTel Scientific Inc., which has other wireless monitoring devices in development).

The front page notes about diabetes that there are “250 million sufferers today – spiking to 350 million worldwide by 2025.”

Yes indeed, that’s a lot of suffering. But wait! The advertisement provides “a comprehensive analysis of the exploding worldwide diabetes crises – plus a STOCK PICK perfectly positioned to capitalize on this staggering growth.”

So those of us with diabetes may be suffering, but at least we can make some money along the way.

Look, we're grateful to the many companies that produce wonderful products for diabetes care, and I recognize that the quest for profits is what spurs innovation, investment and risk taking – all of which ultimately benefits diabetics. So we don’t mind that many corporate executives and investors, as well as any number of doctors, researchers, and scientists, have enjoyed commercial success from the glycemic burdens of our daily lives. But this advertisement explicitly highlights the devastation of the disease (“the number four cause of death worldwide”) as an investment opportunity (“Monitoring, pharma and insulin: $50+ billion.”) (And, note from Kelly, the combined sales in this area are high, but they aren't anywhere close to $50 billion. Monitoring is just under $7 billion globally, and oral drugs and insulin are still under $20 billion.)

That strikes us as a bit, well, awkward.

And what of the GlucoTel itself? Will it, as the ad promises, “revolutionize the way people monitor blood glucose ...”

We aren’t so sure.

The device uses “Bluetooth wireless technology” that “eliminates the greatest hurdles in diabetes management: securely recording information and making it available and useful.” Here’s how it works:
• Patient tests blood sugar on the GlucoTel meter.
• Using Bluetooth, the meter transmits measurement information to a cell phone.
• Patient may enter additional information – weight, meals, workout – directly into the cell phone.
• Complete data set is transmitted to a GlucoTel Web site.
• Patient can graph and analyze numbers.
• Medical professionals can long in, review data, and send messages directly to patients.

This last point appears to be GlucoTel’s key selling point, and such a Web site would make communications between patient and provider more efficient. The problem is that doctors, nurses, and educators are not paid for those kinds of services – telephone conversations, emails, etc. - so we aren't sure how much demand there is for this yet. They should be paid for the services but most aren't, and most providers already feel overwhelmed by the demands of diabetic patients. Our health care system does not adequately reimburse the cognitive skills (such as analyzing an endless stream of glucose numbers) that providers must use for this disease, and health care professionals have no financial incentive to do extra work in caring for patients (again, analyzing those glucose numbers), even if technology might make it a bit easier.

In fact, we don’t believe that inferior technology is the reason that diabetic patients don’t test more often (or in some cases, test at all). We think the reasons are more complex, but they include the failure of health care providers to educate patients about why testing is important and what to do with the numbers. If patients don't know how to connect the dots, and if the behavior won't change, there may not be many reasons to test.

In other words, GlucoTel’s technology may be great, but unless the company can convince providers to carry an extra load, it won’t do much good.

What’s more, we’re always a bit skeptical about technology that complicates a patient’s life. Patients can already download their meters directly onto their computers and graphically display their numbers. GlucoTel requires the added step of a cell phone – what if you get a call while you’re transmitting? Regardless, it’s more work for the patient. (If patients could get on-call advisory about the numbers that would be something else, but of course, it isn't reimbursed at present.)

Finally, the GlucoTel requires 10 seconds to read your number after applying the blood. Most meters do it in five seconds, and for those of us accustomed to that, the 10-second wait will feel like an eternity.

BodyTel Scientific may indeed be a great stock, but for now, I wouldn’t bet my last glucose strip on it.

James S. Hirsch

03/19/2007 in Diabetes - devices | Permalink | Comments (2)

Sontra closes down, still amidst revolutionary claims ...

A matter-of-fact press release went out yesterday from Sontra announcing that it would cease operations. The troubled device manufacturer had all but announced this last quarter when it said it would run out of funds at the end of this year. This is another reminder of how difficult the non-invasive monitoring market is - the company has over time said that various products were in development (non invasive and continuous) for various markets (consumer, ICU) ... early results from nine highly-trumpeted (by the company) trials did not progress well.

We have utmost respect for ongoing research in diabetes, but we don't think it's right when companies raise patient expectations too early. It has been stated on the Sontra website for some time for example, that continuous monitoring for diabetes self testing should exceed 20% market penetration by 2009. Estimates that three million people in the US alone will be using continuous monitors in two years when major reimbursement challenges remain is irrresponsible, because it implies to patients that coverage will not be an issue. It's also an overstatement to claim market growth in a category (blood glucose monitoring) at 15%.

The Sontra website characterizes its product in development as revolutionary and notes that there is large potential upside to the company's market valuation. This makes it easy to understand why most prefer the more under-the-radar companies that don't make big claims too early.


Sontra Medical Corporation Announces Plan to Cease
Operations and to Voluntarily Delist From Nasdaq
FRANKLIN, Mass., Dec. 27, 2006 -- Sontra Medical Corporation (Nasdaq:
SONT) today announced that it will cease operations because it has been unable
to raise additional capital. Sontra previously announced that it had sufficient cash
to continue operations until December 31, 2006. The Company had been
working on seeking additional capital and the possible completion of a merger
transaction; however, the Company has not been successful in completing a
financing or transaction. The Company intends to terminate all employees, and
through an orderly wind-down of its operations, pay its current liabilities and
make appropriate accommodations for creditors. The Company's Chief
Executive Officer, Thomas Davison, will continue as Acting Chief Executive
Officer on a part-time consulting basis, and the Company's Chief Financial
Officer, Harry G. Mitchell, will continue as Acting Chief Financial Officer on a
part-time consulting basis. Messrs. Davison and Mitchell intend to continue to
pursue financing for the Company, while exploring the sale of the Company's
remaining assets, including its intellectual property portfolio.
In connection with Sontra's decision to cease operations, Sontra has elected to
voluntarily delist from the Nasdaq Capital Market. The Company has provided a
voluntary delisting notice to the Nasdaq Stock Market. On November 22, 2006,
the Company received a notice from the Nasdaq Stock Market indicating that
the Company was not in compliance with Nasdaq's requirements for continued
listing under Marketplace Rule 4310(c)(2)(B) because the Company did not have
either: (i) a minimum of $2,500,000 in stockholders' equity as of September 30,
2006, (ii) at least $35,000,000 market value of listed securities, or (iii) at least
$500,000 of net income from continuing operations for the most recently
completed fiscal year or two of the three most recently completed fiscal years.
On December 7, 2006, the Company submitted a plan to Nasdaq explaining how
it intended to achieve and sustain compliance with all the Nasdaq Capital Market
listing requirements. As of this time, the Company has been unable to complete
its plan, which included completing a financing or merger transaction, and has
therefore not regained compliance with Marketplace Rule 4310(c)(2)(B).

In addition, on October 17, 2006, the Company received a deficiency letter from
the Nasdaq Stock Market indicating that the Company was not in compliance
with Marketplace Rule 4310(c)(4) because for the previous 30 consecutive
business days, the bid price had closed below the $1.00 minimum per share
requirement for continued listing set forth in Marketplace Rule 4310(c)(4). The
Company has not regained compliance with Marketplace Rule 4310(c)(4).
Sontra has not arranged for the listing of its common stock on another national
securities exchange or for the quotation of its common stock in a quotation
medium. The Company's quotation for its common stock is expected to appear
in the "Pink Sheets" under the symbol "SONT." The Company's common stock
may also be quoted in the future on the OTC Bulletin Board provided a market
maker files the necessary application with the NASD and such application is
cleared.
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a technology leader in transdermal science and is
developing a non-invasive, continuous transdermal glucose monitor ("CTGM")
for principal use in the Intensive Care Market. Through its platform technology,
the SonoPrep® Permeation System, combined with technical competencies in
transdermal drug formulation, analysis, delivery systems and biosensors, the
Company is creating a new paradigm in transdermal drug delivery and diagnosis.
The CTGM and other company products are being developed for several billion
dollar market opportunities, all utilizing skin permeation, chemistry and
biosensor technology developed by the Company. In addition, the Company
owns technology for transdermal delivery of large molecule drugs and vaccines.
# # #
Any statements contained in this press release that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, a determination by the Company to wind down its business or file for bankruptcy; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology, including a continuous transdermal glucose monitor for the hospital ICU market; the expected size of the market for the continuous transdermal
glucose monitor for the hospital ICU market; the expected benefits and efficacy of the SonoPrep device in connection with diagnostics, vaccine delivery, glucose monitoring and transdermal science. These and
other factors are identified and described in more detail in our filings with the SEC, including, without
limitation, our respective annual reports on Form 10-KSB for the year ended December 31, 2005, our
most recent quarterly reports on Form 10-QSB, and our current reports on Form 8-K. We do not
undertake to update these forward-looking statements made by us.
# # #
SonoPrep is a registered trademark of Sontra Medical Corporation. All other
company, product or service names mentioned herein are the trademarks or
registered trademarks of their respective owners.

12/29/2006 in Diabetes - devices | Permalink | Comments (0)

Seattle Times on Medtronic - not a case...

There was an article in today's NYT about a woman who used a Medtronic pump but didn't have a safety feature set - see below. The article seems to imply that this is Medtronic's fault, which seems absurd. Anyone who gets a pump is responsible for knowing how it works and how it operates. Although doctors and nurses can help with that, in my view, it's part of the burden of being diabetic to figure out how to best take care of yourself. It's well-documented how having diabetes is so like walking a tightrope - ironically too much careful care can prompt serious hypoglycemia. For the Seattle Times to imply that it is Medtronic's fault that the woman slipped into a hypoglycemic coma is wrong - if more people are successful at sueing companies for behavior that went wrong that is ultimately their own responsibility, then pretty soon we'll have companies deem it not worth it to even make these devices. Similarly, is it the doctor's or nurse's fault? I don't think so. They can't foresee every problem - that's why the patients have instruction manuals. The companies do have a responsibility to make sure the manual is clear and understandable but beyond that, I think patients can take responsibility for their own care - they need t, no one else will, and resorting to suing seems going far too far ....

Your Courts, Their Secrets
Woman's coma leads to secrecy, silence
By Ken Armstrong and Justin Mayo

Sylvia Lane, a diabetic, lay in her apartment bed in Lynnwood, comatose and alone, her blood and brain in desperate need of sugar.

But the medical device she'd just received instead kept pumping insulin into her body, pumping and pumping, starving her brain and making it more unlikely she would ever wake up.

Lane was 17 weeks pregnant. Her husband was on an aircraft carrier, halfway round the world. Relatives were calling but getting no answer.

The pump, about the size of a cellphone, had a safety feature designed to stop the insulin flow in emergencies like this. But the feature wasn't on. The pump had been shipped to Lane with the option turned off, and the device's instructional video devoted only 15 seconds to it, saying nothing about why the feature should be used.

Ultimately, Lane suffered severe and permanent brain damage. Her family sued Medtronic Inc. — the parent company of the pump's manufacturer — alleging the pump was unsafe. Medtronic had already sold 150,000 insulin pumps in the United States.

A "defective" product — but what product?

Four years ago, a lawsuit alleged that a medical device was unsafe and that the University of Washington Medical Center had committed malpractice. But the whole file was sealed. Under a public-disclosure request, The Seattle Times got a copy of the complaint from the UW — but almost every meaningful detail was blacked out, including the name of the medical device.

What happened to Sylvia Lane could have yielded insight into the pump's design and instructions, alerting patients and health-care providers to the importance of this safety feature, originally called a "Deadman's Switch."

But when Medtronic settled the lawsuit three years ago, the entire court file was improperly sealed, hiding every allegation and discovery behind an electronic password.

What's more, Medtronic failed to disclose Lane's injury to the federal government, which uses such reports to spot problems with medical devices and to protect the public.

Lawsuits and regulatory reports allow patterns to emerge and warnings to sound. Here, there was merely secrecy and silence.

The Seattle Times got this file opened three months ago as part of a continuing investigation of improperly sealed court records.

Lane's family also sued the state of Washington, alleging the University of Washington Medical Center committed medical malpractice while instructing Sylvia on the pump's use. The state settled, using taxpayer dollars. But the UW, despite being asked for all its records a year ago, has yet to reveal the amount.

The following account relies on the court file. The lawyer for Lane's family said he cannot comment, nor can the family, because the parties agreed to confidentiality as a condition of settlement. Medtronic also declined comment, citing the settlement agreement and Lane's privacy.

A pump that mimics the pancreas

Michael Lane and Sylvia got married in 1989, then moved about as his Navy career dictated. In 1995, they were living in Naples, Italy. That's when Sylvia learned she had type 1 diabetes.

Her pancreas didn't work. It wasn't producing the insulin she needed.

Glossary

Diabetes: A disease in which the body cannot properly convert sugar, starches and other food into energy. An estimated 20.8 million adults and children in the United States are diabetic. Long-term complications include heart disease, blindness, kidney damage and amputations. There are three major types: type 1, type 2 and gestational diabetes.

Insulin: Insulin is a hormone normally produced by the pancreas that helps convert sugar from food into energy the body uses. The pancreas releases more insulin when blood sugar goes up, and less as blood sugar drops.

Type 1 diabetes: People with type 1 diabetes have a pancreas that doesn't produce insulin. To survive, type 1 diabetics must get insulin from daily injections or an insulin pump. An estimated 5 percent to 10 percent of Americans diagnosed with diabetes are type 1.

Hypoglycemia: Hypoglycemia is a condition in which blood sugar is too low. If untreated, it may lead to unconsciousness, coma or death. Diabetics that become hypoglycemic need to eat or drink something to raise their blood sugar.

Source: American Diabetes Association

Insulin, a hormone, counteracts rising blood sugar. When blood sugar goes up, a healthy pancreas releases more insulin. When blood sugar goes down — during sleep, for example — insulin production decreases. The pancreas acts as a regulator, keeping blood sugar from going too high or low, either of which can mean sickness or death.

Sylvia now needed to inject herself with insulin, using a syringe.

The couple moved to Washington in 2000. In August of that year, Sylvia, then 34, learned she was pregnant. Soon after, Michael, a lieutenant, left for duty in the Persian Gulf.

Sylvia lived alone in their Lynnwood apartment.

Because her blood sugar wasn't under control, Sylvia went to the UW's Diabetes in Pregnancy clinic. A doctor there prescribed an insulin pump. Sylvia's insurance helped her buy a pump, a model 508, for about $5,100. The pump arrived in October 2000.

Insulin pumps came onto the market in the 1980s. Today's models weigh just a few ounces and can hold a several-day supply of insulin. A thin tube runs from the pump, worn on a belt or in a pouch under clothes, into the user's stomach. Mimicking a pancreas, the pump steadily releases small amounts of insulin. It can also be programmed to release larger doses — to anticipate a meal, for instance.

Pumps help minimize the highs and lows, reducing diabetes' long-term effects, such as kidney failure, limb loss and blindness.

But pumps also carry risk. If someone's blood sugar drops too much, he can go into a hypoglycemic coma. Hypoglycemia demands sugar, not insulin. But the pump doesn't know that. It keeps pumping insulin — and the user, unconscious, can't turn it off.

MiniMed, the maker of Sylvia's pump, recognized this danger early on. It created a safety feature in the late 1980s that would stop the insulin flow if the user didn't press a button for a set number of hours. Company documents initially called it a "Deadman's Switch." It later became known as the "Auto-Off."

Medtronic, a multibillion-dollar company based in Minnesota, acquired MiniMed in 2001. This took place a year after Sylvia received her pump and a year before her family filed suit.

When Sylvia's pump arrived, the Auto-Off was deactivated. That's how the company ships all its pumps, to this day.

Sylvia's pump came with an instructional video. The video, 48 minutes long, devoted only 15 seconds to the Auto-Off, and that came more than a half-hour into the tape. "A safety feature which can be helpful for every pump user," the video called it. But the video didn't say why anyone might want the pump to stop pumping. It didn't say how the feature could save users from harm.

Medtronic Inc.

Headquarters: Minneapolis, Minn.

Employees: 37,000 worldwide

Annual sales: $11.3 billion

Products include: Implantable pacemakers and defibrillators for the heart; insulin pumps; stents for vascular diseases; devices to treat spinal pain

That video would become emblematic of this question:

Insulin pumps help diabetics. The 508 appears to be a good pump. The Auto-Off appears to be a smart feature. But how can it be a safety feature if many people don't know why they need it?

17 calls — and no answer

On Oct. 25, 2000, a Wednesday, Sylvia met with Emily Holing, a diabetes educator at the UW clinic. Holing hooked up Sylvia's pump and showed her how to use it.

This same afternoon, Holing documented two episodes of hypoglycemia for Sylvia, 15 minutes apart. Each time Sylvia needed to drink orange juice.

Holing didn't activate the Auto-Off on Sylvia's pump. She understood the feature, Holing said later, but didn't think Sylvia should use it. "I don't want the insulin interrupted during pregnancy," Holing said in a deposition. She advised Sylvia to use a "buddy system," with a friend or relative making regular checks on her.

Sylvia had pizza that evening, then drove home. She wouldn't be heard from for three days.

Friends and family tried calling Sylvia on Thursday, Friday and Saturday, leaving 17 messages. Sylvia's twin sister lived three hours away. On Saturday she traveled to Sylvia's and, with another relative, went inside. They found Sylvia on her bed, unconscious, lying in vomit. Her insulin pump was attached and running.

Sylvia was in a hypoglycemic coma. Paramedics injected her with sugar water and transported her to the hospital.

She gradually emerged from the coma but suffered permanent and severe brain damage. Memory, comprehension, reading, writing, walking, problem solving, judgment — all were impaired. Sylvia could speak only in combinations of two or three words, such as, "I'm fine." Medical experts said they expected little improvement. She would need round-the-clock care for the rest of her life.

Doctors terminated Sylvia's pregnancy Nov. 11, at 20 weeks, fearing the unborn child had suffered serious injury.

10 deaths — with few details

In May 2002, Michael Lane filed suit in King County Superior Court, on his and Sylvia's behalf.

The lawsuit named two sets of defendants.

Medtronic, the lawsuit alleged, violated Washington's product-liability law: The pump's warnings were insufficient and its design unsafe. The Auto-Off should be automatic, not an option, the lawsuit alleged. Had the feature been activated and the insulin cut off, Sylvia could have emerged from her coma and sought help before suffering brain damage, the lawsuit contended.

The lawsuit also accused the UW Medical Center of medical malpractice, saying Holing failed to advise Sylvia adequately on the pump's use and risks.

Christopher Otorowski, a Bainbridge Island lawyer, represented Michael Lane.

A year into the suit, Otorowski cited 15 reports filed with the U.S. Food and Drug Administration (FDA) for a nine-month period ending in March 2003. Although light on detail, the reports disclosed 10 deaths and five injuries suffered by people using Medtronic's insulin pumps.

The reports, Otorowski said, constituted "a trend or pattern of deaths." He said Medtronic should divulge more information about each case. The company, he wrote, was concealing information about the pump's risks "from the public, the medical community and the government."

Before approving a new medical device, the FDA requires clinical studies or testing for safety and effectiveness. But MiniMed had bypassed that step by saying the devices were "substantially equivalent" to a generic infusion pump used for medical fluids, Otorowski said. That general-purpose pump was approved before 1976.

The company made and sold insulin pumps "without anything more than a rubber stamp," Otorowski wrote.

Medtronic defended its pumps in general and the safety option in particular. The Auto-Off "is not some mysterious and nefarious device that dooms unsuspecting pump users to hypoglycemic comas," wrote Douglas Hofmann, a lawyer representing the company.

Medtronic said the role played by Holing, the UW diabetes educator, should free the company from any claims of liability. How could Medtronic be blamed for shipping the pump with the safety feature off, the company argued, when Holing had decided Sylvia shouldn't use it anyway?

The company also said the law does not require it to warn users about risks. The pump is available only by prescription, Medtronic said, so the company's duty is to ensure that health-care providers prescribing the pump understand its features. And in this case, Medtronic said, Holing understood the safety option and chose not to activate it.

Medtronic tested Sylvia's pump afterward and determined that it "performed flawlessly," Hofmann said. The company called any demand for a redesign "manifestly irresponsible."

Medtronic also challenged the relevance and reliability of the 15 reports to the FDA. The reports said little or nothing about the Auto-Off feature. Plus, none of the reports concluded that a pump had caused a death or injury, Medtronic said.

Motions that become moot

As the October 2003 trial date approached, Otorowski demanded more and more information from Medtronic. He wanted records of other lawsuits; customer complaints; details of adverse-event reports to the FDA; documents on the government-approval process.

Medtronic and Otorowski sparred over what documents the company would have to produce. Ultimately, the judge would have to decide.

In August 2003, the UW settled the claim against it. But the university has yet to disclose what it paid, even though that figure is a public record.

The same month, just before a hearing to determine if there was enough evidence to warrant trial, Medtronic and Michael Lane also settled. The judge had not yet ruled on Otorowski's demands for additional records — so those motions became moot.

Together, Lane, Medtronic and the UW asked for the entire file to be sealed. They said they wanted to keep private Sylvia's medical information and Medtronic's proprietary records; to protect the Lanes from financial predators; and to honor the parties' settlement agreement, which required that the amount remain confidential.

The joint sealing request also made one other argument — a perplexing one, given Otorowski's prior reference to the pump's "insidious danger."

"It is unlikely that the sealing of this court file would be of interest to any other individuals," the request said. "This is a unique case involving the claims of a single individual."

In October 2003, Judge Richard Jones sealed the file.

This year The Times challenged that order. Just because the parties want their settlement a secret is no grounds to seal an entire file, the newspaper argued. And where legitimate privacy concerns exist, limited parts of documents can be blacked out.

Jones opened the file back up.

"Tip of the iceberg"

Manufacturers must file reports with the FDA when they become aware that a medical device has malfunctioned or may have contributed to a death or serious injury.

The key word is "or." That's the word used in federal regulations: malfunction or injury.

In the Lane lawsuit, Medtronic acknowledged that it did not report Sylvia's injury to the FDA. A Medtronic director wrote in court documents that the company makes a report "if a malfunction is identified and it meets" reporting requirements.

He used the word "and."

"By making this convenient word substitution, the defendant has created an imaginary loophole," Otorowski wrote. Medtronic's interpretation requires a malfunction — in effect, erasing injury as grounds for reporting, he argued. Lane's lawsuit didn't claim malfunction. It alleged that Sylvia suffered severe brain damage because of a flawed design and insufficient warnings.

Otorowski said Medtronic's reporting practices were "deceptive" and put the company's "credibility squarely at issue."

One of Lane's experts, William Damaska, once directed the FDA's Division of Compliance Operations. The FDA uses "adverse-event" reports to issue recalls, safety alerts and labeling changes, Damaska wrote. Doctors use them to make choices about treatment and medical devices.

Sylvia's injury "clearly" met the reporting criteria, Damaska wrote. Medtronic's failure to alert the FDA, he said, suggested that "what is reported is only the tip of the iceberg."

Medtronic said any suggestion that it had not reported other events was "entirely speculative."

Nationally, other lawsuits have also accused Medtronic of reporting lapses. Medtronic, a Fortune 500 company with annual sales of $11 billion, makes all kinds of medical devices. Other lawsuits have alleged that Medtronic failed to make timely warnings to the public and physicians about problems with implantable heart defibrillators and with the tubing on insulin pumps.

In addition, the company agreed last summer to pay a $40 million fine to settle civil allegations that it provided kickbacks to doctors, to encourage them to use its spinal products. The kickbacks included sham consulting and royalty agreements, as well as lavish trips, the U.S. Justice Department said.

Which device? The words are blacked out

Some lawsuits allege a broad threat. But sealing the file can make it nearly impossible to figure out what happened.

When The Times began this investigation, it identified 420 sealed civil suits in King County. The names of the parties were available, but little else.

The Medtronic case stood out. The company sells pacemakers, defibrillators, insulin pumps, heart-valve products. Did the lawsuit claim some device was defective? And if so, which one?

Because the UW — a public entity — was also a defendant, The Times asked for its records from the lawsuit. A sealing order applies to the courts; it does not suspend open-records laws for other public entities.

In January the university turned over the complaint, a document that lays out the allegations. This provided a first glimpse inside the court file. But the university — citing patient privacy — had blacked out just about every meaningful detail in it.

The complaint said some medical device was unsafe. Which device? That information was marked out.

The newspaper contacted Medtronic. In February, a spokesman said the company couldn't comment on the lawsuit because the file was sealed. But his e-mail added:

"Medtronic and the entire medical technology industry follow strict guidelines and regulations stipulated by the FDA regarding product development, safety, effectiveness and quality. We take those guidelines and regulations very seriously, and must — by law — report any incidents that could potentially harm our patients. Medtronic would not intentionally hide information that could potentially jeopardize patient safety by sealing a court file."

Lawmakers do an about-face

The Washington Legislature passed two laws in 1993 to prevent secrecy in product-liability cases.

One barred parties from entering confidentiality agreements that concealed a public hazard. The other kept judges from signing orders that hid such dangers.

But in 1994, lawmakers did an about-face. The former law was repealed, and the latter, diluted.

Gone was the rousing endorsement of the public's right to know about hazards. The new law said the public has two interests: knowing about threats to safety — and making sure that businesses can keep trade secrets. A judge must balance the two before approving secrecy.

The new law has rarely, if ever, been used. A search of published appellate opinions failed to turn up even one case where it has been applied.

But the law still allowed an outsider to challenge a confidentiality agreement as contrary to the public interest. And that's what The Times is doing.

The newspaper has asked a judge to void the confidentiality agreement between Medtronic and Michael Lane. Doing so might free the parties to discuss the case and reveal how much Medtronic paid.

The newspaper's motion is still pending.

Ken Armstrong: 206-464-3730 or karmstrong@seattletimes.com; Justin Mayo: 206-464-3669 or jmayo@seattletimes.com

Copyright © 2006 The Seattle Times Company

12/17/2006 in Diabetes - devices | Permalink | Comments (0)

MCAC meeting in Baltimore to have big time implications for continuous and traditional glucose monitoring reimbursement

Today, Wednesday, August 30, 2006, the Medicare Coverage Advisory Committee will hold a meeting to discuss glycemic control in patients with diabetes. The meeting will be held in Baltimore, MD with sessions from 8:00am to 4:30pm EST and the purpose of the meeting will be to determine the efficacy and need for self-monitoring of blood glucose (SMBG) for the Centers for Medicare and Medicaid Services (CMS). Importantly, the meeting will address the issue of reimbursement for continuous blood glucose monitoring. How there could be a need for a meeting to assess whether SMBG has efficacy is positively beyond us ... we are eager to see what the prevailing views are on CGM.

The MCAC meeting must fit a significant amount of information and discussion into one day - let's hope it starts out strongly and gains in strength! The Committee plans to review research on: glycemic control using a continuous glucose monitor, the relationship in glycemic control between outpatient and Medicare populations, the linearity of effects of glycemic control, and the correlation between an increase in hypoglycemic risk and clinical outcomes. As for desired clinical outcomes, the MCAC will be looking for a diminished progression of the disease, reversing of diabetic complications, and alteration of morbidity/mortality in the Medicare population. All these are hard to prove since long-term outcomes trials are needed. The Committee plans to not only review the available data but to identify topics that require further investigation, which will be very interesting.

On July 17, 2006, the MCAC posted questions for its panel on the topic of glycemic control. The responses to these questions will constitute the frame of tomorrow’s meeting. Many groups, including AADE, Abbott, and AAFP, submitted answers to these questions. We note that originally there were quesitons that didn't address continuous monitoring, but the more updated set does.

Many organizations and doctors and nurses have spent significant time in preparing presentations for the meeting, and they are all online at www.jdrf.org/mcac. By and large, we're blown away by the work that has gone in, though we are not that optimistic about the likely findings. We're frustrated that the government doesn't appear to be in "prevention pays" mode ~ we keep hoping that changes and with the slew of thought leaders on tap tomorrow - Irl Hirsch, Howard Wolpert, Ann Peters, Steve Edelman, Bruce Bode, Aaron Kowalski - can help change some prevailing views.

As to what the various organizations said! First, in their comments to the MCAC, AADE included a Position Statement on Self-Monitoring of Blood Glucose (SMBG): Benefits and Utilization, which will be published in the November/December, 2006 issue of “The Diabetes Educator,” the organization’s journal. AADE’s sentiments towards SMBG are clearly strongly felt, and extremely positive, unsurprisingly. The firmly-established organization of diabetes educators suggests that SMBG has revolutionized diabetes care by improving patients’ glycemic control. In fact, SMBG is an essential component to the AADE’s 7 Self-Care Behaviors. AADE cites the DCCT and UKPDS studies as having confirmed the numerous benefits of tight glycemic control for patients with diabetes, among them a reduction in both microvascular and macrovascular complications (shown through DCCT and EDIT).

The AADE comments for the MCAC meeting cite several studies to support the point that SMBG is successful in increasing glycemic control. Among many pieces of evidence, the AADE cites the Schwedes et al. study (2002), which showed that meal-related SMBG for patients with type 2 diabetes lowered their A1C levels. AADE recommends the use of SMBG to all individuals with diabetes and urges all healthcare professionals to support and use SMBG with their patients. AADE goes even further than recommending when they say that, “safe and appropriate blood glucose monitoring methods need to be taught…”

According to the AADE comments, SMBG is important for diabetes care because it allows for patients to learn more about their condition and to take a more active role in their care. A patient who is more focused on his or her care will be more likely to reach glycemic control goals. With all the additional information SMBG offers to patients about their blood glucose levels, patients gain an invaluable sense of their health and well-being. Not only is this important in motivating the patient to achieve their glycemic control goals, but it helps patients to discover a personal regimen that works for them.

Abbot, like AADE, confirms the benefits of SMBG and strict glycemic control, as measured by A1c levels. Abbot aims to present scientific-based evidence linking frequent testing and the improved glycemic control to a decrease in unfavorable outcomes of Type I and Type 2 diabetes among Medicare patients. Abbott has synthesized findings from multiple studies in an impressive, comprehensive white paper, entitled, “Clinical Value of Glucose Monitoring and Glycemic Control in the Medicare Diabetes Population and the Promise of Continuous Glucose Monitoring.”

Abbott maintains that existing evidence of the benefits of SMBG in the Medicare population is strong and ample enough to permit an adequate comprehensive assessment of outcomes. Abbot also references large clinical studies, such as the DCCT and UKPDS to make its case for SMBG. Referencing the updated analysis of the UKPDS study in 2000, Abbot also makes a strong case for the impact of reduced A1c levels in diabetes-related mortality.

However, the same confidence extended towards SMBG cannot yet be extended to Continuous Glucose Monitoring (CGM). Compared to SMBG, CGM, is new technology. Thus, Abbott maintains that, at this time, evidence for CGM among Medicare patients is only promising, as more research among the elderly population is required. While, a current assessment of CGM benefits among these patients is still premature, Abbott will discuss the emerging data in this arena.

While Abbott focuses much of the evidence on a reduction of A1c levels, AAFP’s Kevin A. Peterson paints a different picture regarding glucose monitoring and A1c levels. Taking into consideration the unique needs of and barriers faced by the elderly population, he insists that the measured impact of SMBG using A1c values provides a “very incomplete assessment” of the benefit of blood glucose monitoring. Further, in response to one of the questions posed by MCAC, Dr. Peterson, states that he is not confident that an increase in the frequency of glucose monitoring will automatically improve A1c levels in elderly patients.

Most of AAFP’S comments, as delivered by Dr. Peterson, are cautious in nature due to what the doctor believes is lack of evidence of glucose monitoring in large cohorts of elderly patients, as well as less faith in the patient’s A1c level as the single most important indicator of glycemic control. Personally, we believe strongly that A1c is important but not the only measure - we think it is crazy to even question whether SMBG reimbursement is too high.

In addition to AADE, Abbott and AAFP, we will listen to remarks by JDRF, Medtronic, IHPM, LifeScan, and several others. We look forward to reporting on tomorrow's MCAC meeting in our next issue of DCU - this has enormous implications for the health and future of traditional as well as continuous blood glucose monitoring and we are watching and waiting and will report back...

08/30/2006 in Diabetes - devices | Permalink | Comments (0)

What do you mean I can't wear my pump on the plane?

Normally, we like to think ourselves as people, not patients, those of us with diabetes here at Close Concerns. Mostly, we think that we should be able to look after ourselves so well that we do better than others without a chronic illness because with ours, if we eat well, pursue exercise, and do everything we can to reduce our A1cs safely, we can do better than the average person (yes, mortality was what we were thinking, but also morbidity).

Alas, today, we were reminded that we take so much for granted. Three people with diabetes on pumps here in the US tried to board planes this morning and were told that they needed to check the pumps. Check it!?!?!? Pumps are what keep us alive. Pumps also, I realized, just make me feel reassured, like life is going my way, when I feel my pump. It's part of me. If someone told me to take it off and check it, I'd think they were certifiably insane.

We were reminded all day today of Jose Saramago's Blindness. Things felt like they did after the first person went blind ... how crazy will this get? How nonsensical? How will we adapt? How won't we?

Back a bit on the mundane side, relatively speaking - it's amazing that there is such lack of knowledge about diabetes and pumps ~ the tyrrany of course is far worse and far be it from me to complain about those trying to make the country and world safe. BUT, many more people would be on pumps if they were easier ... and if that were so, they might not be such an object of abject fascination and there might not be any threats like the ones this morning.

Kudos, and just plain gratitude to Animas for jumping on this issue very very early; as we understand from a number of HCPs, they informed pump competitors and worked with the higher-ups in the government (ringing the acting attorney general, for example, who has diabetes) to address this problem. Right now, no one's pump is being pulled out of their abdomen that we've heard of since the transportation sites have been taken care of. ... welcome news in this sobering time. As much as I'm worried about terrorism for everyone, short of terrorism, having someone taking away my pump would be about the most daunting thing I could imagine.

08/11/2006 in Diabetes - devices | Permalink | Comments (0)

Medtronic receives approval for stand-alone sensor

Medtronic announced FDA approval this morning for its stand-alone glucose sensor. As a reminder, the 522/722 pump has been shipping since April, and the sensor/transmitter that is part of that system has been shipping since June 19. Items of note:

1. This product has predictive alarms and rate of change alarms - this is a more advanced suite of data than the sensor that is part of the 522/722 and as such a positive for Medtronic.
2. Calibration is every 12 hours and sensors are "typically" used for three days. In terms of outcomes, the release says that CGM technology identifies four-times more glucose excursions requiring therapy adjustment than just fingerstick monitoring alone. REAL-Time alarms help reduce the duration of hypoglycemic (low blood sugar) episodes by 48 percent. (This hasn't been published that we're aware of but we believe it's data from last year's EASD)
3. It will be launched by the end of the year, so it will be some time before it is available so won't immediately compete with Dex Com.
4. There is no pricing information as of yet for this product.
5. Other features that are attractive to users are that it is waterproof, it has expanded trend graphs - 3, 6, 12, and 24, hours (Dex Com has 1, 3, and 9) showing the effect of diet, exercise, medication, and lifestyle on glucose values.
6. Feedback has been very good on the Medtronic CareLink software as you know and we would expect that to be a big part of marketing for this product.
7. It sounds like it would be some time (12 - 18 months) before these extra data features would be incorporated into the 522/722.
8. Although this won't be launched til year-end as noted, it will be shown at AADE, so we will look forward to checking it out in LA in a few weeks (Aug 9 - 12).
9. Medtronic has more experience than any other company in this area. The press release below says Medtronic has shipped nearly 500,000 sensors to date (this would include CGMS we assume)
10. This is a modest positive to Medtronic although we assume it's primary focus continues to be its pump business. It won't compete immediately wiht Dex Com but the approval is a reminder that other competition is coming for Dex Com's STS (and for Abbott's Navigator,not yet approved).


Press release below.

Press Release
Source: Medtronic, Inc.
Medtronic Receives FDA Approval for Guardian(R) REAL-Time Continuous Glucose Monitoring System
Monday July 17, 7:00 am ET


System Provides Patients Superior Protection than Fingersticks Alone

MINNEAPOLIS--(BUSINESS WIRE)--July 17, 2006--Medtronic, Inc. (NYSE:MDT - News) today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardian® REAL-Time System, a doctor-prescribed continuous glucose monitoring (CGM) system for improved diabetes management. Especially well suited for diabetes patients who frequently monitor their glucose levels, the Guardian REAL-Time System is intended to help protect patients by alerting users to high and low glucose levels. The REAL-Time information and retrospective glucose trend data provided by the Guardian REAL-Time System are designed to help patients more tightly control glucose levels. Improved glucose control has been shown to significantly reduce the likelihood of certain long-term complications, including blindness, kidney failure, amputation, impotence, and heart disease. The system will be available nationwide by the end of this year.
Source: Medtronic, Inc.


·
The FDA-approved Medtronic Guardian(R) REAL-Time Continuous Glucose Monitoring System alerts diabetes patients to high and low glucose levels, allowing them to better manage their diabetes. (Photo: Medtronic). View Multimedia Gallery


"The Guardian REAL-Time System is the culmination of more than seven years of research into continuous glucose monitoring technology," said Robert Guezuraga, president of the Diabetes business at Medtronic. "With more than 2,400 patient years of glucose monitoring, and more than 470,000 glucose sensors shipped, Medtronic is leading the way with the newest generation in continuous glucose monitoring technology."

Unique features only available with the Guardian REAL-Time System include predictive and rate-of-change alarms and expanded trend graphs. In addition to high and low glucose alerts, these new predictive alarms are designed to warn patients of significant glucose changes well before they become dangerous. Comprehensive trend graphs show the effect of diet, exercise, medication, and lifestyle on glucose values in three, six, 12, and 24 hour increments. All glucose data can be downloaded using the Medtronic CareLink® Therapy Management Software.

The Guardian REAL-Time System glucose sensor is a tiny electrode inserted under the skin that measures glucose levels in the interstitial fluid found between the body's cells. The sensor is connected to a transmitter that sends glucose readings every five minutes to a monitor, which displays up to 288 readings a day - nearly 100 times more information than conventional monitoring.(a) This additional information provides better protection against frequent glycemic highs and lows, and empowers patients to be more proactive about their diabetes management. CGM technology identifies four-times more glucose excursions requiring therapy adjustment than just fingerstick monitoring alone. REAL-Time alarms help reduce the duration of hypoglycemic (low blood sugar) episodes by 48 percent.

The Guardian REAL-Time System is indicated for continuous or periodic monitoring of glucose levels of adults (ages 18 and older) with diabetes mellitus for the purposes of improving diabetes management. The glucose sensor is typically discarded and replaced after three days of use. All therapy adjustments should be based on measurements obtained using a blood glucose meter (fingerstick measurement). The device requires one calibration point every 12 hours.

Current standards for assessing glucose control include A1C tests and fingerstick measurements, yet both have limitations. An A1C test, which measures glucose control during a three-month period, is important for long-term management, but it is only an average and and does not reveal day-to-day glucose fluctuations that can harm 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 hypoglycemic events, and have difficulty assessing glucose fluctuations while they sleep.

Medtronic Diabetes currently markets the CGMS® System Gold and the recently FDA approved MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System – the world's first insulin pump with REAL-Time continuous glucose monitoring. The MiniMed Paradigm REAL-Time System has all of the benefits of CGM plus the added value of precise insulin delivery through the use of insulin pump therapy. Medtronic Diabetes continues to lead the industry in developing new medical device technologies to improve overall diabetes management.

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.

* Based on three fingersticks a day

About Medtronic’s Diabetes Business
The Diabetes business at Medtronic (www.minimed.com) is the world leader in diabetes management. The company’s products include insulin pump therapy, continuous glucose monitoring systems, related disposable products and diabetes management software.

About Medtronic
Medtronic, Inc. (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.

07/17/2006 in Diabetes - devices | Permalink | Comments (0)

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