Close Concerns Weblog

AACE - "like being on acid"

It almost amazes me how many brilliant people there are in diabetes.

So, Kelly here, I'm in Chicago, I've had an incredible steak lunch, and I get to the conference and I'm walking down to the exhibits. I see one of my favorite people in the field, a very cool industry watcher who always says just exactly what is on his mind. ("Yeah," he said recently to me three months after another conference where we had sat down for a session by a former thought leader, "Everyone in this room has been peer-reviewed by this guy and had at least one rejection - most multiple." Bemusement. "But that doesn't mean the lecture will be any good."  Two minutes pass. "I'm out of here, I just really can't deal with it - so 1980s.")

Anyway, my friend - let's call him Peter, because that's so not his name - ambles up to me. "Have you seen it yet?" he demands. "Nice skirt."

"Seen what?" I sputter. I'm already behind!

"The Dex Com booth," he says. "You haven't seen it?"

"No, not yet, although I have heard it's supposed to be excellent."

"Okay, what do you think you'll think, on a scale of 1 to 10?"

"Ten," I say, because I know I'll like it. I like the product, I like the speed, and I like their approach to the patient - like we are real people, not people with some sort of problem.

"Yeah," he says. "It's pretty solid." For him, this is like he is bestowing the highest honor one could imagine. "Basically, it's like being on acid."

Beat, beat. I've GOT to get down to see it. I am at once so loving but not even really able to deal with the anticipation.

"Okay," he says. "I'll walk you there. I don't believe you. Not 10/10."

"Really ...." I say, doubtfully. I don't like to exaggerate, but I have heard it is really something.

We walk down, we walk by some cool booths (the Pfizer inhaled insulin station is good, the Byetta booth is swarming, the LifeScan booth is tiny, but the Ultra 2 is garnering lots of excitement) and I keep looking around, wondering if I have missed it. Maybe I did! But I thought I would notice it, they said?

All of a sudden, I am face to face with a GIANT screen in these excellently vivid colors - a whirlwind of images has walked into my life. I stare. I see all sorts of cool images. People. Gorgeous, together, caught up in the midst of life - walking, biking, cooking, kissing, sleeping, lazing around - and okay, I know, I'm a marketer's dream! But that's what it is - all these people look and seem and sound normal. They don't have this underlying tenseness going on. ("What, you are blaming that on your diabetes and your constant low level of hypoglycemic anxiety?" my sweet husband would say. "Let's face it. You basically love angst.") So okay, either way - but the video, I am hooked. I am literally transfixed. You MUST go see it at ADA - they'll have it there too. If you ever want to know what the average intensively managed patient wants their life to be like, go look at this. It's all about living uninterrupted, tangle-free, from diabetes.

Thinking about it, life was probably like this in the early 1980s, when the first blood glucose monitors happened and when docs worried about patients killing themsleves etc. So with that, I'm not sure what the worst thing was that happened, just like I'm not sure what could be worst here. I don't take it lightly, at all. Insulin is a )#&)@(#$@ing scary substance - the therapeutic index is lower than you even want to come close to imagining. So yes, people could do harm with this. But isn't that true of basically everything?

The big things they got right. I want to live like the people in their commercials and I have to say (again, I'm a marketer's dream, but this is also true) - since I went on the STS a couple of weeks ago, I'm a heck of a lot closer.

Now, for this thriving commercial market to start - I hope the FDA and CMS kick it into high gear.

Back to the booth. My cool, lax, hippie friend watches me, smiling. "Yeah," he said, "I thought so. You knew you'd like it because you knew it would speak to youi. But you didn't get that it would be a 30 out of 10, not a 10 out of 10, how much you like this whole drama you are watching."

"No, I said. "Even you don't get it. This ad? This is basically infinity out of ten."

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Check it out if you can. And thank you to the FDA for making it possible for some of us to live like this. But at $35/sensor, not very many of us can -- for me, I'm lucky, it's just about making other sacrifices and I can do that - but most people can't.  So ~ onward!

New DexCom accuracy figures published in AACE abstracts - wow!

The abstracts for the meeting of the American Association of Clinical Endocrinologists have been released, and the buzz is all about a study of DexCom's continuous glucose sensor. Investigators Lois Jovanovic, Howard Zisser, Timothy Bailey, Roy Kaplan, and Satish Garg report on a study that enrolled 86 subjects, 69 with type 1 diabetes and 17 with type 2. Each subject wore three sensors, each for a 7-day period, with one period masked and two unmasked; during the unmasked time patients received trend graphs (1-, 3-, and 9-hour) and high alerts at 200 mg/dL, low alerts at 80 mg/dL, and a hypoglycemia alarm at 55 mg/dL.

Impressively, the study reports a median absolute relative difference of 11.4% and a mean absolute relative difference of 15.7%. Additionally, subjects spent 24% more time in the target range and as well as significantly less time above 240 mg/dL or below 55 mg/dL (33% less time and 43% less time, respectively). These results outshine DexCom's data published in Diabetes Care in January of this year, at which time investigators reported an median ARD of 21.2% and a mean ARD of 15.9%. The abstract's Clarke error grid A+B of 97.2% trumps the previously reported 95.4% as well, and the improvements in time spent in particular ranges are higher, though this is tough to interpret without seeing the time spent reported in actual minutes (rather than percentages as given in the abstract).

From what we hear, DexCom has been inundated with orders, a reflection of significant "pent up" demand for a continuous sensor, and the timing of the improved accuracy data can only bolster the success of the STS launch. We'll be reporting in more detail on these findings and others from Chicago when we arrive at AACE next week!

EXCELLENT day for Medtronic! Sensor augmented pump approved ahead of schedule ~

In a real surprise, Medtronic got approval several months earlier than expected for its sensor augmented pump - 522/722 (label allows adults but not children to use the device).
Medtronic had submitted the PMA in October so this is very fast timing.
As we understand it, reps were trained by webex Friday and they are out selling, although the sensor ("self-pay") part of the package won't be available til late June

While ADA will likely be a blow out for Medtronic, we'll look for them to have at least an informal unveiling at AACE in Chicago next week. The timing is very positive for them in terms of conference season and from a competitive perspective, since Dex Com had had the marketplace virtually to itself since it's own approval.

Regarding pricing, as we expected, the stratospheric Guardian RT prices have come down. Sensors will be priced at $35 each (below the $40/sensor they have been pricing the Guardian RT sensors)
CGM "sub-system" (basically the Guardian RT) system will be priced at $999 (below the ~$2900 where they have been pricing the Guardian RT). We wouldn't look for anything but scant reimbursement until 2007 at earliest.

Device success will hinge on gaining reimbursement; in the meantime, we don't believe the cash market will be large, but it will be vocal.

Now comes the interesting part: how to teach patients how to use this, how to teach doctors how to use this (especially the majority who have not kept up with CSII), and how to pay doctors to use this with patients when the devices are not being covered anyway.

Lots of questions - we salute the company for this approvval.

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

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 (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. (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.

JAMA bolsters glycemic variability

Check out the current issue of JAMA - incredible pieces by a number of thought leaders, including Drs. Michael Brownlee and Irl Hirsch. It doesn't get any better than this.

There are three notable pieces in tomorrow’s (April 12) edition of JAMA.

Monnier D. et al. “Activation of Oxidative Stress by Acute Glucose Fluctuations Compared With Sustained Chronic Hyperglycemia in Patients With Type 2 Diabetes.” JAMA April 2006. 295 (14): 1681-1687.

Brownlee M. and I. Hirsch. “Glycemic Variability: A Hemoglobin A1c-Independent Risk Factor for Diabetic Complications.” JAMA April 2006. 295 (14): 1707-1708.

Saudek, Christopher, et al.  “Assessing Glycemia in Diabetes Using Self-monitoring Blood Glucose and Hemoglobin A1C.”  JAMA. 12 Apr 2006.  295(14):1688-1697.

Our top takeaways: 1) Dr. Louis Monnier (Lapeyronie Hospital, University of Montpellier, Montpellier, France) and colleague’s study strengthens the view that there is a meaningful association between glycemic variability and oxidative stress that is independent of A1C.  2) This association suggests that future interventional trials should specifically examine glycemic variability in addition to traditional glucose measures of A1C and mean glucose levels – although Dr. Monnier’s study looked at type 2, we feel the analysis is relevant to type 1s. 3) In the meantime, since 2/3 of patients in the US are not at their glycemic targets, we believe therapies that reduce glycemic variability in addition to lowering A1Cs should be particularly encouraged (we haven’t, by the way, found a good source for type 1 average A1Cs nationwide or globally).  In particular, we believe a number of tools should increase in importance in the diabetes armamentarium and should be used more aggressively:
• Byetta (to lower post-prandial hyperglycemia and smooth out blood glucose levels)
• Symlin (to lower post-prandial hyperglycemia and smooth out blood glucose levels)
• Insulin (to reduce glycemic variability as well as A1Cs that can’t be reduced otherwise)
• Alternate medication delivery devices (particularly pumps, which allow fine tuning of insulin doses, and particularly disposable pumps, which patients are more likely to find easy to use)
• More frequent A1C monitoring for those out of control (current average is 1.5x/year, but should be 4x/year for those with A1Cs < 6.5 and at least 2x/year for those with A1Cs >6.5)
• Increased episodic glucose monitoring for those not at glycemic targets
• Real-time continuous glucose monitoring (to identify post-prandial, in particular).

Although standard deviation of glycemic levels wasn’t measured in trials, anecdotally, all the therapies and tools enable a “smoothing out” of blood glucose levels, and an increase in the “quality of A1C” – this may or may not be in addition to a reduction in the A1c itself.

We continue to believe, although not directly related to these articles, that better reimbursement of time so healthcare professionals can teach such therapy (for example, what to do when patients see high post-prandial data, etc.) is badly needed; as this is such a problem now, therapy that is relatively simple (e.g., Byetta) will be rewarded.

AP article draws attention to hospital care for obesity

While the long-term health risks of obesity are receiving increasingly frequent media coverage, comparatively little attention is paid to the routine challenges that are part of everyday life for the obese. Therefore, it was encouraging to see an AP article today by Jim Salter focusing on hospitals’ efforts to better equip themselves to treat extremely obese patients, some of whom weigh as much as 600 to 700 pounds.

Salter cites numerous examples of the difficulties that arise when hospitals are inadequately prepared for obese patients who require larges chairs, stronger beds to support their weight, wider CT scan machines, and special syringes (4 _ inch syringes are sometimes insufficient to penetrate through patients’ fat), among other issues. To illustrate how hospitals are improving, he focuses specifically on the Barnes-Jewish Hospital in St. Louis, which is currently replacing beds and wheelchairs with bigger models, widening doorways, buying larger CT scan machines, even replacing slippers and gowns. Salter points out how these improvements not only benefit obese patients, themselves, but also the nurses who must move and lift them during their visits – he mentions a recent survey of 900 nurses and X-ray technicians in which the majority of participants reported chronic pain or injuries from moving patients.

Although we are glad to hear that hospitals are addressing these issues, it is disheartening both that we have reached such a state where these measures are necessary and that it has taken so long to address them. According to the patient care director at the Barnes-Jewish Hospital, the current changes at the hospital are occurring after the discovery that between one-third and half of its patients are obese with up to a third weighing over 350 pounds. If such a significant trend is just beginning to have an affect on hospitals, one can only imagine how long it is going to take other institutions and industries to make such adjustments for the rapidly increasing obese population.

Diabetes hits the mainstream again - Byetta in the comics!

We talk a lot about how diabetes really hit the mainstream in 2005 and it hasn't stopped - but today we saw yet another new tier of visibility. A comic strip in Sunday's (April 2) Washington Post - Mark Trail by Jack Elrod - made reference to the gila monster and therapies for type 2 diabetes. The comic is ahead of its time, as it basically forecasted incretins becoming stand-alone treatment for type 2 diabetes. Fascinating!

(Ed. note - unfortunately the link only worked on Sunday.)