VO L U M E 1 • I S S U E 6

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in this issue
From the Editor .............. 1 Quotable Quotes ........... 2 (S)he said what?!? FingerSticks ................... 2 Yay for Halloween… or? diaTribe Dialogue ........... 3 Noted cardiologist, Dr. Nissen on Avandia Learning Curve ............... 6 Dismantling Avandia, Actos and TZDs Conference Pearls .......... 9 Live from DT, EASD, AADE and TCOYD Logbook.......................... 17 Ready, steady, camp! SUM Musings ................ 20 Kerri downloads from day 1 Glo’s diaTribe .................. 22 Oh the things we do Test Drive ........................ 23 Alisa’s ally, Alli. Profile.............................. 24 Stephen Covey and the 7 Habits of Highly Effective People with Diabetes Trial Watch ...................... 25 Ultra-rapid insulin and studies for grandparents and grandchildren What We’re Reading ...... 26 Sneak preview: “This Little Diabetes Book You Need to Read” and “My TCOYD newsletter” NewNowNext ................ 28 Buses, ports and cubes

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research and product news for �������������������������������������������������� people with diabetes from the editor
enerally, I’m pretty upbeat about diabetes. Don’t get me wrong, I wouldn’t wish it on anyone; but I do believe that if we get the right information and support, we can manage the disease and prevent many – if not all – the complications. But two things have really depressed me of late. First, at a recent diabetes technology conference, we heard a speech given by one of the most important figures in the field – Dr. Richard Kahn, the Chief Scientific and Medical Officer of the American Diabetes Association. We found much of his take on diabetes technology inexplicable and insensitive– not exactly what we expect from the ADA. Specifically, Dr. Kahn cast doubt on the efficacy of technology to improve patient care. At one point, he said, “Self-monitoring costs taxpayers over $1 billion, even though there hasn’t been a single randomized, control trial demonstrating benefit.” The last time we checked, the DCCT and the UKPDS were two trials that demonstrated that tighter glycemic control resulted in fewer long term complications – and how would tighter control be achieved, without blood glucose monitoring? Dr. Kahn also derided pump technology, even though many we know – including diaTribe managing editor James Hirsch and myself – find pump therapy a huge benefit. We couldn’t help but wonder – has Richard Kahn spoken to diabetic patients about these products? If he or one of his children were diagnosed with diabetes tomorrow, would he urge that child be limited to three glucose strips a day (the Medicare limit for those on insulin), and would he refuse to consider an insulin pump? And if the ADA’s chief scientist doubts the value of these tools, how are we supposed to lobby for greater coverage from insurers? (We provide further details on this disappointing talk in our Conference Pearls.) My other diatribe is aimed at the FDA. This government agency, charged with the scrutiny of new drugs and devices, recently rejected a drug called Symlin to be used with long-lasting, basal insulins, Lantus or Levemir, for type 2 patients. Symlin is already approved for those taking mealtime insulin, but in the US, that’s only a couple of million patients out of 15 million diagnosed. The FDA is supposed to reject new drug applications when there are safety concerns, but there are none to be found with the published data for Symlin. So why the rejection? The FDA didn’t say. It’s possible that the FDA – which has been criticized for being too lenient with industry – is now overcompensating with excessive safety. But the price of caution is high – fewer alternative drugs that some, if not many, patients could use. We recognize that all therapies have a risk-benefit trade-off, but we find the FDA’s unexplained timidity a setback for diabetes care. Let’s hope that in the near future, we will see enlightened leadership from the top agencies and organizations working for improved diabetes care. Yours truly,

G

To subscribe to diaTribe, visit www.diaTribe.us.

Kelly Close

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quotable quotes
“Something is going on with obesity, and it ain’t just eating at McDonalds.” —Dr. Richard Atkinson, arguing recently that the obesity epidemic around the world is caused by a virus.

diaTribe staff
Editor in Chief Kelly L. Close Managing Editor James S. Hirsch Contributers Kaku Armah Daniel Belkin Michael Chen Jennifer Ho Jenny Jin Surya Kundu Sierra Walton Mark Yachoan Design Gina Wilson

“The problem with reversing obesity is that in the short term, nothing feels better than eating ice cream while watching TV; the negative consequences are all long-term.” —Gary Foster, PhD, on the challenge of weight loss. “Decades of multidisciplinary research have transformed science fiction into scientific possibility!” —Dr. Philippe Halban, speaking at EASD about the pace and direction of scientific research on beta cell regeneration. “Unfortunately, in this current environment where the FDA is unwilling to act, and is really impotent in many ways, the only way we get action is to directly inform the public. I would argue that while it made life tough and did create some anxiety, it also meant that a lot of people that were being harmed by a drug got to talk to their physicians about it. A lot of physicians had the opportunity to change the therapy for their patients. Frankly, wide public discussion of the Avandia affair has led to much more good than harm.” —Dr. Nissen, arguing that his meta-analysis and the subsequent media firestorm were good in the long-run for patients. “Type 3 diabetics – the non-diabetic partners of diabetics – always think they know it all.” —Dr. Steve Edelman, discussing the challenges of a relationship between people with and without diabetes at a recent TCOYD meeting. “Well-controlled diabetes is the leading cause of nothing.” —Dr. Bill Polonsky underscoring that diabetes is, as he put it, “not a death sentence.”

diaTribe advisory board
Jennifer Block, RN, CDE Dr. Zachary Bloomgarden, MD Dr. Bruce Bode, MD Dr. Nancy Bohannon, MD Dr. Bruce Buckingham, MD Dr. Wendell Cheatham, MD Dr. Steven Edelman Dr. Barry Ginsberg, MD, PhD Debbie Hinnen, CDE Dr. Irl Hirsch, MD Jeff Hitchcock Dr. Lois Jovanovic, MD Dr. Francine Kaufman, MD Dr. Aaron Kowalski, PhD Mirasol Panlilio Dr. William H. Polonsky, PhD Michael Robinton Jane Jeffrie Seley, NP CDE , Dr. Paul Strumph, MD Virginia Valentine, CDE Dr. Howard Wolpert, MD Gloria Yee, RN, CDE

fingersticks

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ILLUSTRATION: DANIEL BELKIN

D I AT R I B E • R E S E A R C H A N D P R O D U C T N E W S F O R P E O P L E W I T H D I A B E T E S

diaTribe dialogue
PHOTO COURTESY OF THE OFFICE OF DR. NISSEN

Dr. Nissen was named as one of TIME Magazine’s “100 most influential people” in May 2007

Dr. Steven Nissen is a highly regarded coronary artery disease researcher and a vigilant activist in public health policy matters. He is currently the chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic and was previously the president of the American College of Cardiology. Earlier this year, Dr. Nissen caused a firestorm when he published a study indicating that Avandia may increase the risk of having a heart attack. Dr. Nissen is no stranger to controversy: his expressed concerns that Vioxx might cause blood clots contributed to Merck’s decision to withdraw the drug in 2004. This year, Dr. Nissen was named one of the “100 Most Influential People” by Time magazine. In an interview with diaTribe Editor in Chief, Kelly Close, Dr. Nissen talks about his view of the climate of diabetes care in the United States today and about the Avandia controversy of late. After reading our interview with Dr. Nissen, it may be helpful to read our Learning Curve about Avandia and the TZD class of drugs. Kelly Close: Thank you so much for taking the time to speak with diaTribe, Dr. Nissen! It’s a real pleasure for us. To start with, we’re curious about how, as a cardiologist, you first became interested in studying PPARS (the main biological target of drugs in the TZD class). Dr. Steven Nissen: Well, it actually goes back quite a long ways. I was aware from the very beginning that there were a lot of issues with PPAR drugs, which affect a very large number of genes. We don’t know what most of those genes do. Whenever you see a drug like that, you always worry about off-target effects that the drug was not designed to produce. My concerns accelerated in September of 2005 when muraglitazar came before the FDA for approval. I did not attend the hearing, but I did have an interest in the class of drug. The night before the hearing, I looked at the FDA’s briefing documents and immediately saw that there was a rather large excess of adverse cardiovascular events in the patients who received muraglitazar. And they were serious events: death, stroke, heart attack, that sort of event. So I assumed that the FDA advisory panel would recommend unanimously that muraglitazar not be approved. As you may recall, they actually voted 8 to 1 to approve the drug. I was just shocked. I immediately went into action and took the data from that FDA advisory panel, analyzed it independently with my statistician, and published in JAMA a few weeks later that the drug was doubling the risk of the really serious cardiovascular consequences of diabetes. Then in September of last year, the DREAM trial was published, and if you will excuse the pun, the DREAM trial was a nightmare. There was a drug, rosiglitazone (Avandia), which reduced the incidence of new-onset diabetes by 60 or 70 percent. But all of the cardiovascular events were going in the wrong direction. You want to prevent diabetes to avoid the complications of diabetes, the most important of which is heart disease. Eighty percent of all diabetics will die of cardiovascular disease, so this was very troubling. Then the ADOPT trial was published, and the same thing happened. It showed a 33 percent excess of major adverse cardiovascular events. Now the really big shocker was that just as I was getting ready to publish the manuscript, I learned that GlaxoSmithKline, the maker of the drug, had actually done its own analyses beginning in September of 2005. They actually submitted to the FDA that their own analysis showed a statistically significant 31 percent increase in myocardial
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Dr. Steven Nissen

So I assumed that the FDA advisory panel would recommend unanimously that muraglitazar not be approved. As you may recall, they actually voted 8 to 1 to approve the drug. I was just shocked.

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ischemic events (heart attacks). They’d informed the FDA of this risk. But neither the FDA nor the company informed any of the rest of us. I personally believe in the right of patients and providers to know the totality of information on the benefits and risks of drugs. Kelly: What do you think it says about endocrinology that it took a very noted cardiologist to intervene in this matter? Dr. Nissen: Endocrinologists have a serious difficulty. They’ve spent their entire lives believing that the most important thing about treating diabetes is to reduce hemoglobin A1c, so they’ve had a very glucose-centric view, and I simply don’t agree. I believe that the reason you want to lower HbA1c is to reduce the complications of diabetes. This singular focus on blood sugar – because that’s what they could measure every day with finger sticks and all of that – has led to a misunderstanding of what it is that we’re trying to accomplish when we give these drugs. With a PPAR (like Avandia) that causes myocardial infarctions, fractures, macular edema, and heart failure – I don’t really care if it lowers blood sugar. It’s not of benefit to patients. Kelly: From a patient perspective, when your meta-analysis came out from the New York Times, it just kind of blindsided everyone. It caused a lot of anxiety. In retrospect, was there a better way to disseminate the information so that so many people were not left so concerned? Dr. Nissen: Actually, I think we did exactly the right thing. And let me make a couple of comments about this. First of all: the idea that I should have told the FDA first. The FDA already knew! The company had told them two years earlier that the drug was causing this effect. I went to the Congress because the FDA had chosen not to act. Second point: it is very important to understand that when these things are handled in a quiet fashion, you don’t get change. Do you know that when you put a black box warning on a drug that its sales are rarely affected at all? If the FDA had quietly relabeled rosiglitazone, people would have continued to be exposed to the drug. The reason that it’s a good thing that the media jumped all over this is that the drug is effectively not being used anymore. Unfortunately, in this current environment where the FDA is unwilling to act, and is really impotent in many ways, the only way we get action is to directly inform the public. I would argue that while it made life tough and did create some anxiety, it also meant that a lot of people that were being harmed by a drug got to talk to their physicians about it. Kelly: Oh, that’s interesting. Wow. Now, you had also complained that diabetologists were not putting enough patients on statins (editor’s note – these are drugs that reduce LDLcholesterol). Can you tell us a little more about that and what you might urge our readers to ask their doctors? Dr. Nissen: Well, our guidelines suggest that if you have diabetes, you should be on a statin, and yet when you look around the country, only 40 to 50 percent of diabetics are actually on statins. This is why I’m troubled by the glucose-centric approach to care. We know statins reduce the risk of the most lethal complications of diabetes by 25 to 35 percent, and yet they’re not being used … Kelly: As you have emphasized, most diabetes patients do die of cardiovascular disease. Can you talk a little bit about the changing roles of the endocrinologist and cardiologist and if the fields are moving together?
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I think we did exactly the right thing. First of all: the idea that I should have told the FDA first. The FDA already knew! The company had told them two years earlier that the drug was causing this effect. I went to the Congress because the FDA had chosen not to act.

If the FDA had quietly relabeled rosiglitazone, people would have continued to be exposed to the drug. The reason that it’s a good thing that the media jumped all over this is that the drug is effectively not being used anymore.

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The ADA recommends these guidelines:
A1c:

<7%
Preprandial plasma glucose:

90-130 mg/dl < 120 mg/dl

Peak postprandial: Systolic blood pressure:

Dr. Nissen: They are moving together. I refer to myself as a diabeto-cardiologist. Only if they have very complicated issues managing insulin regiments or so on do I refer them for (an endocrinologist) consultation. I think that a cardiologist should manage diabetes. Now I’m very careful how I manage them, and you can bet they get statins. Almost all of them, if they have acceptable renal (kidney) function, get metformin. I’m very cautious about sulfonylureas because of the cardiovascular issues with that class of drugs. And I do use pioglitazone (Actos) in some patients if they have good ventricular function and are not at risk for heart failure. I’ve got a lot of patients that are on insulin glargine (Lantus) at night and so on. I do treat their blood sugars, and I get their HbA1c’s down, but I also treat them for their global risks. Kelly: Speaking of global risk, what about weight? Do you use GLP-1 (small protein which causes lowering of blood sugar) agonists, for example (Byetta is the only approved GLP-1 agonist)? Dr. Nissen: Yes, I do. The other thing that I’m probably much more aggressive about than most endocrinologists is blood pressure control. Kelly: That’s good for our readers to consider to and to ask their doctors and educators about. What is your view about whether or not Avandia should stay on the market? Dr. Nissen: Well, let me put it to you this way. I have deliberately avoided calling for its removal. I was very disappointed in the performance of that advisory panel, frankly. I mean, there’s logic to voting 20 to 3 that the drug increases cardiovascular risk, but then to not recommend decisive action is a little hard to understand. Kelly: How would you explain that? Dr. Nissen: Well, let me tell you something that you need to understand here: In these matters, courage is very rare. No one understands the FDA better than I do as an outsider. These panel meetings are in front of all your peers, knowing that the pharmaceutical industry is with whom everybody works and is really keen on not having you take decisive action. People just don’t stick their necks out. And that’s exactly what you saw. Kelly: Hmm – that’s a lot for us to think about! From a patient perspective, is there any other advice that you have? I know some patients are very concerned because they go ask their doctors and their doctors only have all of five minutes to spend with them. Dr. Nissen: Well, that’s why patient empowerment is so important. I personally believe that we’re in an era now when patients need to be better informed. You know, my patients have been to the Internet. Often, when they come to see me, they have already looked this up. And if your doctor is reluctant to take the time to talk to you about your concerns, get another doctor. Kelly: I guess we’re just sort of worried that the number of internists is falling and the number of endocrinologists is falling. So maybe they all have to get cardiologists! Dr. Nissen: Well, maybe more cardiologists need to start treating diabetes. Kelly: What would make that happen?
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< 180 mmHg < 80 mmHg

Diastolic blood pressure: Total cholesterol:

< 200 mg/dl < 100 mg/dl

LDL-cholesterol: HDL-cholesterol

>40 mg/dl in men >50 mg/dl in women
Triglycerides:

< 150 mg/dl

Talk to your healthcare provider about the right targets for you.
Reference: 2005 American Diabetes Association Guidelines

These panel meetings are in front of all your peers, knowing that the pharmaceutical industry is with whom everybody works and is really keen on not having you take decisive action. People just don’t stick their necks out.

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Dr. Nissen: Oh, I think you have to educate cardiologists better about it. I still refer patients if I can’t successfully manage them and I get great help. But I also don’t act like I’m deaf, dumb, and blind when a patient with diabetes comes in my office with heart disease. Kelly: That’s interesting. Is there any other advice you would give patients? An aspirin a day, anything like that – not to be too formulaic! Dr. Nissen: There’s no cookie-cutter formula. It all has to be customized. My advice is to find a doctor who takes the time to explain it to you, to talk to you about what you need to do. Take your own blood pressure and make sure it reaches the guidelines that are recommended. Check your blood sugar often. Be an informed patient. Stay on top of your disease and you’ll do a lot better. It’s really tough. We’ve just got to keep at it. Organizations that have published newsletters like yours are really important because you’re going directly to the patients. Frankly, there’s no better advocate for your health care than you. Kelly: This has really been terrific; we appreciate your taking the time to speak with us. — In the interest of full disclosure, the Cleveland Clinic notes that it receives “Research support for clinical trials (from) AstraZeneca, Eli Lilly, Takeda, Sankyo, Sanofi-Aventis, (and) Pfizer. All reimbursement is directed to the Cardiovascular Coordinating Center at the Cleveland Clinic (C5). No personal reimbursement is accepted for directing or participating in clinical trials. Companies are directed to pay any consulting fees directly to charity. No reimbursement is paid to Dr. Nissen and there is no tax deduction involved.

learning curve

T2
The events compounded by the white-hot media focus, induced fear and uncertainty among some patients, and many patients promptly discontinued their use of Avandia – sometimes without seeking the advice of a healthcare provider.

Dismantling Avandia, Actos and TZDs
By Mark Yarchoan

F

irst introduced into the market in 1999, Avandia quickly became one of the bestselling diabetes drugs on the market, with approximately one million users in America within seven years. However, in May 2007, Dr. Steven Nissen (interviewed in this issue of diaTribe) and his colleague Kathy Wolski published a “meta-analysis” (a pooled analysis of multiple studies) in the New England Journal of Medicine showing that Avandia may increase the risk of heart attack by 43 percent. The findings made headlines in major newspapers, and even prompted Congress to investigate if the FDA had mishandled the approval of Avandia. The events, compounded by the white-hot media focus, induced fear and uncertainty among some patients, and many patients promptly discontinued their use of the drug – sometimes without seeking the advice of a healthcare provider or without going onto any other medication regardless of whether they saw a doctor or educator! Months later, the Avandia debate has died down somewhat. Following an FDA advisory panel review, the drug remains on the market, as does a similar drug called Actos – although both drugs now carry a “black box warning,” the most severe warning issued by the FDA, to address the risks of congestive heart failure. A recent letter to the FDA from Senator Charles Grassley, who has been investigating the FDA’s handling of drug-safety issues, indicates that the FDA may have come closer to ordering the Avandia off the market than previously thought. In his letter, Senator Grassley asked the FDA to confirm that an
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internal drug-safety oversight board had voted by a narrow 8-7 margin in early October to keep Avandia on the market. If the FDA confirms this 8-7 vote, this will show that there is a split within the agency about whether to pull Avandia off the market. The agency isn’t the only one split about Avandia. Many patients still don’t know what to think about Avandia, or Actos; and the jury isn’t out among physicians, either. Here, we provide some background information on the Avandia and Actos controversy. Thiazo-what? Avandia and Actos belong to a class of drugs called thiazoladinediones (also called glitazars or simply TZDs). Several other TZDs are in development, but Avandia and Actos are the only TZDs currently on the market. A third TZD called troglitazone was removed from the market by its manufacturer in 1999 due to serious adverse liver effects after more than 61 deaths. TZDs can help people with type 2 diabetes lower blood sugar through reducing what is called insulin resistance. The trial ADOPT showed that TZDs have greater “durability” (work longer) than other classes of drugs like metformin or sulfonylureas. TZDs are thought to work by binding to and activating the peroxisome proliferator-activated receptor gamma (PPAR gamma). PPAR gamma is a protein that sits on the DNA in the nucleus of cells. When acted on by a TZD, it makes the cell create proteins that reduce blood sugar and improve insulin resistance. DREAM and ADOPT Two large clinical trials, DREAM and ADOPT, have demonstrated the efficacy of Avandia, but have also raised questions about the drug’s safety. DREAM was a large clinical study evaluating the efficacy of Avandia in the prevention of type 2 diabetes in high-risk patients (note: Avandia is not currently approved for this purpose and we doubt with all the worry about safety that it will ever be approved for diabetes prevention). In this study, Avandia was highly effective at preventing diabetes, but it was also associated with an increase in heart failure, heart attack, and stroke compared to placebo. But, the numbers did not reach statistical significance, and therefore could have been due to chance alone. ADOPT was a long-term (four to six) year randomized study comparing metformin, the sulfonylurea glyburide, and Avandia on the maintenance of glycemic control in patients recently diagnosed with type 2 diabetes. Published in December of 2006, the study showed that Avandia can control blood sugar for longer than either glyburide or metformin. This was very encouraging, because glucose control is the key to preventing complications associated with diabetes such as blindness or kidney disease. However, patients in the Avandia treatment group had a 33% higher incidence of major adverse cardiovascular events, including heart attack, congestive heart failure, and stroke. As with the DREAM trial, the differences did not reach statistical significance, and may therefore have arisen from chance alone. Dr. Nissen would later pool the data from both the DREAM and ADOPT trial, as well as a number of smaller trials, to show Avandia was consistently associated with an increased incidence of adverse cardiovascular events even if no single trial reached statistical significance. Also concerning, there was a higher incidence of fractures associated with Avandia in women (though, quite peculiarly, not in men). Following the discovery that Avandia may increase the risk of fractures in women, the FDA asked Takeda Pharmaceuticals, the maker of Actos (the other TZD), to investigate the rate of fractures in patients taking Actos. Takeda issued the so called “Takeda Letter” that indicated that, like Avandia, Actos increased bone fracture rate in women, particularly in the lower and upper limbs. The increased risk of fracture for both drugs appears to start after about one year of treatment.
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Dr. Nissen published another pooled analysis indicating that unlike Avandia, Actos is not associated with increased heart attack risk. This was particularly significant given that it was Dr. Nissen who originally sparked fears about Avandia.

Actos vs. Avandia The concerns about the cardiovascular risks of Avandia left a dark cloud over Actos. Both drugs have similar efficacy in controlling blood glucose and generally have the same side effects including fluid retention, leading to swelling and weight gain. However, one intriguing difference between Actos and Avandia is their effect on lipid profiles. Avandia increases LDL cholesterol (the bad cholesterol) and increases triglycerides, while Actos has the opposite effect. If Avandia’s effects on lipids are causing the potential increase in cardiovascular risk, then Actos would not be expected to share this risk. Dr. Nissen published another pooled analysis indicating that unlike Avandia, Actos is not associated with increased heart attack risk. This was particularly significant given that it was Dr. Nissen who originally sparked fears about Avandia. Dr. Nissen believes that the difference between Avandia and Actos is due to their difference on lipids. Dr. Nissen and others maintain that Actos and Avandia are completely different drugs and should not be considered equals. Many disagree both with Dr. Nissen’s analysis and his conclusions. As the maker of Avandia and others contend, there are no head-to-head comparisons of Actos and Avandia, and it is very difficult to compare their respective risks. It is conceivable that Actos and Avandia actually have identical risks. Dr. Nissen’s analysis of pioglitazone was based on a relatively small number of studies, and a single study – the PROactive study – contributed most of the data, and the patients in this trial were at a high risk of cardiovascular disease. What Now? Controversy continues to surround Avandia and Actos. Some health care providers believe that only Avandia increases cardiovascular risk, some say both Avandia and Actos do; others argue that neither significantly increases cardiovascular risk – or that any risk is highly outweighed by the potential benefits. Some questions about Avandia may be answered in 2009 when the so called RECORD trial concludes (a large, multiyear trial of Avandia). However, an interim analysis published on June 5 was inconclusive, and it is quite possible that the final analysis will be inconclusive as well. At the EASD Annual Meeting in Amsterdam in September, Dr. Richard Nesto likened the concerns about Avandia to the concerns about the safety of anti-depressants in 2004, which scared users and curbed their use, particularly in teenagers. As a result, after a decade of falling suicide rates in teenagers, the suicide rate started to rise in 2004. Dr. Nesto’s message was that making incorrect safety judgments for drugs that work can make society worse off, and media pressure can be unhelpful when trying to take difficult decisions on balance of evidence. This lesson, he feels, is highly applicable to Avandia – he believes that the excessive focus on safety is taking away from its potential benefits in glucose control. Many others such as Dr. Nissen believe that there is no reason to use Avandia given that there are other options – namely Actos, which is equally effective and may be safer. Other health care providers believe that TZDs should be avoided altogether given the potential risks, or should left as a last resort when other oral agents have failed. As the debate carries on, we hope that a safer generation of so called selective TZDs is on the way – drugs that will work better, decrease LDL cholesterol, increase HDL cholesterol, and have minimal side effects… One can always hope. We’ll certainly be on the lookout for early data to show to you! In the meantime, if you have any questions about how Avandia or Actos affect you, then speak to your health care professional.

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conference pearls
T1/2

Seventh Annual Diabetes Technology Meeting (San Francisco, October 25th – 27th)

… There were almost no limits or constraints to the use of new diabetes technology, he claimed.

We would certainly agree that America is not the best health system globally in some respects – but largely it is reimbursement woes (absence of payments for education, for physician care, for drugs, and for technology) that need to be addressed.

We will be back next issue with more from the Diabetes Technology meeting – for now, we describe below just the keynote talk from Dr. Richard Kahn, Chief Scientific and Medical Officer of the ADA. • To start, Dr. Kahn provided a fascinating history of diabetes care, highlighting that the cost and complexity of treating diabetes has increased. First there was only insulin. Then, in the 1950s/1960s, oral drugs were developed and diabetes care was no longer a simple proposition. In 1964, test strips came about, and in the 1970s the A1c test was invented. Our advisory board pointed out that the A1c test was actually invented in the 60s!! Since the 1970s there has been a “blizzard” of new discoveries, resulting in more data, risks, costs, and complexities. Kahn suggested that the medical industry established enormous marketing budgets, “causing patients to clamor for the latest technology.” Wow! What’s that all about? Last time I checked, my diabetes equipment was helping me to live a far better, more healthy life, one that kept me out of emergency rooms and in the thick of life. • Dr. Kahn continued by explaining that new developments were often justified by trials he implied were sub-par. There were almost no limits or constraints to the use of new diabetes technology, he claimed. We would agree more evidence should be produced to show the value of technology; on the other hand, we also believe many trials are difficult to execute in a “real world” environment. We thought it was surprising that Dr. Kahn didn’t mention that patients do have fewer complications today than they did in the 1950s, that they live longer, and that they have, at least to some extent, a higher quality of life due to better blood glucose monitors, insulin delivery systems, and better, more stable drugs/insulin. • Per Dr. Kahn, as a result of new tools and complexities, the cost of healthcare in the US soared from a small percent of GDP in the 1970s to 16 percent of GDP in 2006 – this amounts to about $7,100 on healthcare per person per year. America does not get its money’s worth, he said. Americans spend more per capita than in any other country, even though health outcomes lag behind many other countries. We would certainly agree that America is not the best health system globally – we would also argue that there are much larger problems than payments for technology – namely the lack of payments to healthcare providers to work comprehensively with patients who are chronically ill. • Diabetes care contributes significantly to America’s healthcare costs. Dr. Kahn emphasized that diabetes costs Medicare a third of its entire budget. Self-monitoring costs taxpayers over $1 billion “even though there hasn’t been a single randomized, control trial demonstrating benefit.” In spite of tremendous spending, the quality of diabetes care in America leaves much to be desired, he said. We would certainly agree that the quality of diabetes care in the US could be dramatically improved but we would cite systemic problems as a bigger culprit than the cost of new technology. • Looking to the future, Dr. Kahn believes that technology will need to bring simplicity rather than complexity, and will need to cut costs rather than increase costs. As health care costs rise faster than inflation, accountability (value provided per dollar spent) becomes more important, he says. We absolutely agree with him on this point and believe most patients and healthcare providers would! As more health care costs are shifted to the patient, Dr. Kahn claimed patients will begin wondering why new technologies increase costs rather than reduce costs, and the patient will begin looking for better value. In the future,
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It’s unfortunate that one of the ADA’s highest staff members seems to feel technology like insulin pumps and CGM (and to some extent event SMBG) show very little, if any, value to patients, healthcare providers, payors, or average Americans.

diabetes technology will need to be more effective, timely, safer, patient centered, efficient, and equitable (these are so called “systems of care” improvements). • Compliance is certainly an issue. Dr. Kahn said that over 70 percent of diabetes patients don’t take their diabetes medications properly, and a technology that could improve patient compliance would improve outcomes tremendously. Technology should identify and reduce errors, rather than add ways to make errors. Gadgets that add complexity will receive more scrutiny than gadgets that simplify diabetes care. There will be a new equilibrium favoring improvements in systems of care advances as opposed to new fancy and expensive technology. We certainly believe medication adherence could be improved significantly – but we don’t think not reimbursing diabetes drugs and technology is the best way to get there! He also didn’t acknowledge that sometimes side effects are the reason people don’t continue to take their medicine. Blaming that on the patient is counter-productive at best. Improving reimbursement for doctors and educators would be a start to enhancing care. Diabetes is complicated and patients deserve more time with their healthcare professionals. • During Q&A, Dr. Kahn joked that the most cost effective solution in terms of healthcare expense would be to urge every American to begin smoking at age 15. This was not met with much appreciation from the audience from what we could tell. • Overall, we are concerned that Dr. Kahn’s views may become a platform and that they will have negative implications for pump and continuous glucose monitoring reimbursement in particular. We certainly agree with Dr. Kahn that the right evidence should be produced to demonstrate value of diabetes technology – we also think from a patient perspective it’s complicated because randomized controlled trials don’t always mimic the real world. We know that some in the audience felt that Dr. Kahn made some asides suggesting that technology like insulin pumps and continuous monitoring (and to some extent even self blood glucose monitoring) were threatened or shouldn’t be valued or reimbursed. If that is the case, this shows very little, if any, value to patients, families, healthcare providers, payors. The ADA has always been a valuable force and we look to themfor leadership in advocating for improved cost control,new products and technology, and reimbursement for products and healthcare providers. — You can see the text to Dr. Kahn’s speech at the ADA website under “healthcare professionals” or go to this link: http://professional.diabetes.org/News_Display. aspx?TYP=9&CID=57894 . Some asides made by Dr. Kahn that were spoken are missing in the written version. As noted, we very much appreciate Dr. Kahn’s role, we agree with much of the speech, and hope that all of us can work toward better reimbursement for diabetes technology and drugs and for better reimbursement for physician and educator time spent with us as patients.

ILLUSTRATION: DANIEL BELKIN

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European Association for the Study of Diabetes (Amsterdam, September 17th-21st, 2007)

Amsterdam was a fabulous location for EASD

In September, the diaTribe team traveled to Amsterdam to attend the 43rd Annual Meeting of the European Association for the Study of Diabetes (EASD). This year, it attracted over 14,500 participants. Compared to its American counterpart, the annual meeting of the American Diabetes Association (ADA), EASD was most focused on basic science and insulin therapy. See below for our EASD Pearls. • The name of the game at EASD? Intensification. Whether discussing glycemic control, macrovascular events (heart attacks, strokes) prevention, or insulin initiation, presenters and chairs kept citing the need for faster, tighter, and more comprehensive diabetes management. Whew, this puts the pressure on us as patients! Some of the field’s
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The exhibit floor at EASD – quite the marketplace of the latest diabetes tools and products.

Healthcare providers browsing the exhibitions at EASD

leading researchers called on all doctors and nurses to be more aggressive in fighting diabetes—change a diabetes management regimen before it fails, they say, and before inadequate management raises our risk of poor health outcomes. This means setting ambitious A1c goals, trying for better post-meal glucose control, and using combination therapy. • All things continuous! Continuous glucose information and continuous subcutaneous insulin infusion (CSII or insulin pumping) both yield better control and higher patient satisfaction. We would agree with this! Several presentations throughout the week suggested that continuous monitoring translates into better glucose management. Pumps also make for better glucose results, particularly in groups such as children, overweight individuals with type 2, and pregnant women with type 1. CSII is associated with less fear of hypoglycemia, less concern about diet restrictions, and higher treatment satisfaction despite the fact that researchers said pumps can be hard to figure out how to use (they call this the “complexity factor” – we are lobbying for more “user-settable” settings we can just all set personally so we can use and ignore features as we wish!). • Appropriately enough, given the theme of intensification, several talks at EASD predicted a trend toward more insulin therapy for type 2 patients. Insulin, no longer just the heavy-duty machinery for reigning in abnormal blood glucose, should be considered a ‘positive therapy’ for positive results. Taking insulin earlier is associated with tighter glycemic control in the short-term and reduced rates of cardiovascular events and hypoglycemia in the long-term, in addition to improved microand macrovascular health. The need for providers to ‘get positive’ (and become more persuasive with us, the patients!) on insulin therapy is clear. In-session surveys showed that attendees believe needle fear is the #1 reason patients do not want to start insulin. Hmm, do we agree with that as patients?! Furthermore, data on type 2 patient opinions show that few believe insulin will help them manage their diabetes better, and almost a third of physicians postpone insulin as long as possible. That’s a problem! If you’re A1c is over 7 and you can’t get it down, we suggest you talk to your doctor and ask if he or she would consider any changes if they were you! Some people believe the 7 percent A1c goal will go down and that we should be at more “normal” A1c levels, like Dr. Nancy Bohannon in San Francisco – so you might ask your doctor about that too. • More intensive management will require greater patient participation. To meet post–prandial glucose (PPG or after-meal glucose) targets, the International Diabetes Federation (IDF) recommends that people taking insulin should test three times a day, including one test at least two hours after a meal. These guidelines might affect people with prediabetes, too, since they are based on PPG. Shifting toward taking earlier insulin also places greater responsibility on patients, since insulin therapy requires patients to get some significant education on dosing, carb counting, and administration. • The Relationship between Insulin Sensitivity and Cardiovascular risk (RISC) trial results show widespread benefits of physical activity. More evidence that we have to get out and move! While exercise and lifestyle intervention were not central themes of the conference, impressive data from this trial suggest many benefits from all forms of physical activity. Total activity, not just intense exercise, improves insulin sensitivity, and increased activity is associated with improved insulin sensitivity independently of waist circumference. The bottom line is that moving during the day is extremely beneficial, irrespective of intensity. • Once again, when it comes to reducing cardiovascular risk, the best tactics involve intense treatment. Cardiovascular (CV) risk is best reduced through tight blood glucose control and intensive therapy, including early insulin initiation. The importance
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PHOTO: MARK YARCHOAN

PHOTO: MARK YARCHOAN

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of glycemia in cardiovascular health is indisputable; 69 percent and 39 percent of patients admitted for acute myocardial infarction (MI or heart attack) or stroke test positive for impaired glucose tolerance (IGT) and undiagnosed type 2 diabetes, respectively. Furthermore, the most common risk factor for CV events in individuals less than 45 years is undiagnosed metabolic disorders and obesity. The American College of Cardiology is working on new guidelines that demand glucose testing before patients admitted to a hospital for acute cardiovascular conditions can be released. • Finally released, a new system for reporting blood glucose. Results from one trial looking at average blood glucose control and A1c have identified a new equation to make numerical assessments of glycemic control more accessible to patients. Researchers hope patients will find it easier to integrate this information into their management behaviors and improve control because the average glucose scale matches that of glucose meters. Here’s a rough idea of how A1c translates to meter readings: 6 percent = 126 mg/dl (7 mmol/L) 7 percent = 155 mg/dl (8.6 mmol/L) 8 percent = 182 mg/dl (10.1 mmol/L) 9 percent = 211 mg/dl (11.7 mmol/L) 10 percent = 239 mg/dl (13.3 mmol/L) • Greater attention must be given to depression in diabetes. The association between diabetes, depression, and adherence exposes the need for new mental health screening guidelines to support providers in identifying patients whose physical health cannot improve without attention to mental health.

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American Association of Diabetes Educators (St. Louis, August 1st – 4th, 2007)

Former Arkansas Governer and 2008 presidential candidate, Mike Huckabee during his opening address at AADE

This year’s AADE in August in St. Louis was extremely educational, as always. We tip our hats to the organizers for putting together an amazing faculty of speakers – especially for the well-attended general sessions that set the tone for four days of insights. . • We applaud Former Arkansas Governor, Mike Huckabee’s initiative in taking on diabetes and obesity, but we think he should also advocate that the government act directly. Mr. Huckabee argued that the government won’t do anything until there’s mass advocacy from the public, but we think it’s going to have to be a more two-way process – patients will have to advocate, the government will have to take action, and it will (unfortunately) be an incremental process on both sides. In our view, the government should take a harder look at reforming food subsidies, for example subsidizing fruit and vegetables. It could also be more proactive in helping businesses and insurers realize that they’ll be more efficient and pay less in the long term (for health costs) if they invest in preventive care. • “We don’t have a health care system, we have a sick care system.” We have a health crisis, which is leading to a health care crisis, and not vice versa. Because we are not focused on prevention, 80 percent of health care expenditures are spent on preventable chronic diseases, which are mostly due to overeating, under-exercising, and smoking. We spend more of our GDP on health care than any other country: 17 percent, compared with 10.5 percent in Switzerland, 9.5 percent for most European countries, and down from there. • Notably, pump and CGM expert, Dr. Bruce Bode, said that insurance companies were likely waiting to see hypoglycemia-related car accidents and comas before they think seriously about reimbursement for continuous glucose sensors. He added that not everybody shows marked improvement simply by using a CGM device. The STAR 1 trial showed that the best results are seen in patients who
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PHOTO: MARK YARCHOAN

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Minority groups have lower frequency of home-glucose testing than whites and less use of intensive insulin therapy. Solutions include culturally appropriate programs – this should not be “taken lightly” – that are economically feasible, with more aggressive insulin and combination therapy in minority groups.

have A1c percentages already below 8 percent. In addition, preliminary results from one of his ongoing studies have shown the need for continued use of sensors in order to maintain improvements in A1c. That makes sense – we also understand that people who look at their CGM devices the most frequently do the best – that makes sense too! If you watch closely, you’re more likely to make changes, of course, especially if you’re on pump therapy and it seems likely if you make frequent small changes, that obviates the need to bigger changes and makes big big shifts less likely to be necessary. • If you have type 2 diabetes and your A1c is above 8 percent, Dr. Leahy says you need insulin and that if you take it, you’ll feel better! Dr. Leahy, a noted endocrinologist from the University of Vermont, said it was great that insulin is now on the same line as second-line therapy in the ADA guidelines. There was applause when he said that people need to be put on insulin earlier. He said that it is imperative that primary care physicians (PCPs) know how to put people on basal insulin – he said, “There’s not enough of us, and many people are going to need it.” Dr. Leahy said he would like to change stepped therapy, such that the first stage is one or two oral drugs, the second stage is basal insulin, and the third stage is basal insulin plus another insulin dose at the biggest meal. Dr. Leahy is also a “big believer in Symlin, an antihyperglycemic drug reported to also help with weight loss in type 1s and insulin-dependent type 2s. As always talk to your physician before altering your therapy. • Dr. Leahy said he often lectures to PCPs. Responding to the prompt, “My biggest problem in starting insulin is:” the first answer from PCPs is always: “My patients won’t do it” (other options are, “Not sure what to do,” “Not sufficient time or support staff,” and “Fear of weight gain or hypoglycemia”). The main problem PCPs say their patients cite is fear of injection. However, less than 50 percent of PCPs have ever (“once in their life”) given a saline injection in the office. “It’s daunting that they don’t know these things.” We personally believe that “physician resistance” might be just as big or bigger than “patient resistance” especially since some doctors don’t think they have the time to teach insulin, given the reimbursement rates for education are almost nil! • To the nearly full hall, the highly-respected Dr. James Gavin of Emory University gave a well-received talk about diabetes outcome disparities among ethnic groups in the US. African Americans are 1.8 times as likely to have diabetes as whites (about 13 percent of African Americans have diabetes) and have 3-5 times the risk of lower-limb amputations, as well as increased risk of heart attack, kidney disease, and premature death. Minority groups have lower frequency of home-glucose testing than whites and less use of intensive insulin therapy. Solutions include culturally appropriate programs – this should not be “taken lightly” – that are economically feasible, with more aggressive insulin and combination therapy in minority groups. • There are real genetic differences among ethnicities, but the epidemic in high-risk minorities is mostly environment-driven. Our genes haven’t changed in the last 30 years, but diabetes has tripled. Numerous barriers exist for improved outcomes: lack of awareness of the disease and its consequences, insufficient access to patient education, delayed diagnosis, living in a disadvantaged community, distrust of medical professionals, failure to treat early and aggressively, and the requirement of complex medical interventions (which means more time and resources) from the provider. • We need especially aggressive treatment for minorities. Dr. Gavin pointed out that the expert National Minority Quality Forum has recommended, given earlier disease onset among minorities, the greater need to attempt to alter the natural history of the disease and to use more intensive therapy with earlier combo therapy and with insulin. He emphasized that the National Diabetes Education Program (NDEP) is working to disseminate information about diabetes and encouraged health care providers to use and refer their patients to its resources.
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He stressed the need for better integration of public health and medical care since patients spend so little time in doctors’ offices and so much time where they “earn, learn, buy, lie, pray, and play.

• The amazing diabetes advocate Dr. Francine Kaufman (Children’s Hospital, Los Angeles) distinguished between type 1, type 2, and maturity onset diabetes of the young (MODY). In children, about 90 percent of diabetes is type 1, less than 10 percent is type 2, and only a small amount (1-3 percent) is MODY. Generally type 2 and monogenic (caused by a mutated single gene) diabetes are post-puberty diseases, although recently there has been a great increase in the number of pre-puberty cases of each. It is often difficult to differentiate type 1 from type 2 diabetes in overweight adolescents. Genetic testing is commercially available and should be considered for any child who fits the MODY diabetes profile – white, not obese, and does not have Acanthosis nigricans, a skin hyperpigmentation often found on the back of the neck or other body folds. • Puberty increases insulin resistance, even in normal weight children. Most children experience a 30 percent increase in insulin requirements during puberty. To date, 17.1 percent of children (age 2-17) are obese, and many of them already have high insulin resistance prior to puberty; this is a fast track to type 2 diabetes. The ratio of girls with diabetes to boys with diabetes is about 1.7 to 1. • Dr. Kaufman discussed the situation of type 1s who gain weight and develop type 2. This situation is growing more common, and Dr. Kauffman suggested that metformin should be considered in such cases. In one study of type 1s, metformin lowered A1cs by 0.6 percent and reduced the insulin dosage by about 20 percent. In another study, metformin had similar benefits, and additionally caused significant weight loss and lowered LDL cholesterol. More studies are required to investigate metformin treatment in type 1s. • Dr. Sanchez of the University of Texas School of Public Health delivered an interesting talk in which he spoke about the need for health reform and improvements in health literacy, especially among minorities. He called for better integration of public health and medical care as well as better prioritization and reimbursement of interventions that most efficiently optimize health. He was often interrupted by bursts of applause from the responsive 1,500+ member audience. He highlighted the need for health care reform to create patient-centered, primary care based, prevention-focused and community-oriented interventions. He stressed the need for better integration of public health and medical care since patients spend so little time in doctors’ offices and so much time where they “earn, learn, buy, lie, pray, and play”. • The health care industry needs to reexamine its priorities. While lauding the value of scientific research, Dr. Sanchez pointed out that getting people to quit smoking may be a more immediately effective tool for diabetes treatment than extended research into “beta blockers”. He noted that if resources were diverted from biomedical research into education, diabetes patients would be in better position to control their disease or avoid it altogether. He cited statistics showing $31,300 spent per quality adjusted life year (QALY) for metformin as opposed to $1,100 per QALY for lifestyle intervention. • During pregnancy, women should have fasting blood sugar under 96 mg/ dL (5.3 mmol), two-hour post-prandial blood glucose (PPG) <140 mg/dL (7.8 mmol), and overnight blood glucose of 65-135 mg/dl (3.6 to 7.5 mmol). Ideally, A1cs should be lowered before pregnancy to as close to normal as possible – pregnancy expert Dr. Lois Jovanovic recommends under 5.5 percent. Exercising when possible remains an important part of glucose control throughout pregnancy. Ketoacidosis (extreme hyperglycemia) can occur rapidly and at lower glucose levels during pregnancy. During the first trimester, morning sickness and food intolerance often contribute to what is called “maternal hypoglycemia”. During the second and third trimesters, insulin resistance increases due to the high levels of many pregnancy-related hormones, and patients need more insulin, perhaps even triple or more what they needed pre-pregnancy. Insulin
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requirements drop back to normal levels or below normal levels after pregnancy, though nursing can cause more glycemic variability than usual as well. • Insulin is the “gold standard” for pregnancy for type 2 patients. Oral agents are not generally recommended for use during pregnancy. There have been no studies yet of Apidra, Lantus, or Levemir during pregnancy. Some studies have found that both insulin and glyburide are equally successful at any given level of fasting blood glucose. Recommendations published recently by the 5th International Workshop - Conference on Gestational Diabetes suggested that glyburide is a useful adjunct (additional therapy) to medical nutrition therapy and physical activity in women with gestational diabetes. Glyburide may be less successful in obese patients or those with marked hyperglycemia earlier in pregnancy. The same international body does not recommend metformin, Byetta, or Symlin for the management of diabetes during pregnancy as trials have not been done to determine safety. • It is easy to come up with a list of four or more cheap and safe medications patients should take daily – ask your healthcare team if a daily dose of the following is right for you: aspirin, an ACE inhibitor – for hypertension, a statin daily (probably, not absolutely), and antioxidants. Switching a totally different category, it sounds like we’re going to see a lot more about fish oils in the literature in the future, and it’s something we should probably all talk to our doctors or educators about taking. • Change is possible, but it’s going to take a generation. We need to first change attitude via awareness, and then change the environment, like better snacks in schools, walking paths, escalators that are turned off at least some of the time!. The action phase is when we get laws once new behavioral norms are in place. Note that this comes after societal changes – we can’t legislate proactively or it will be a battle about personal rights. “Universal coverage is not as critical a goal as “universal health,” he said. “We can get to universal coverage if we want to,” but the most important change to make is a change in culture. The solution is not as simple as laws, governing food in schools, for example – though, he added, these are good goals (he worked with President Clinton to get sugary soft drinks out of school cafeterias).

The fabulous St. Louis Arch added a certain je ne sais quoi to the AADE conference.

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ILLUSTRATION: DANIEL BELKIN

D I AT R I B E • R E S E A R C H A N D P R O D U C T N E W S F O R P E O P L E W I T H D I A B E T E S

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Taking Control of Your Diabetes (Santa Clara, September 15th, 2007)

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If you cannot find time for exercise, you will have to find time for disease.

Well controlled diabetes is the leading cause of nothing.

The Taking Control of Your Diabetes (TCOYD) Conference was held on September 15th 2007, in Santa Clara, CA. From Hawaii to Minneapolis, our very own advisory board member, Dr. Edelman and his team hold about a dozen TCOYD meetings every year – the biggest one in San Diego (on December 8 this year). The Santa Clara meeting was labeled by diabetes veterans as providing “reestablished focus in a positive and affirming way” while neophytes said they “learned more today than (they) ever knew was available.” About 1500 people attended and most break-out sessions were filled to capacity. • Dr. Edelman lamented the statistic that 92 percent of Europeans were using insulin pens compared to only 12 percent in the U.S., saying, “If you are not using a pen, you are in the dark ages.” Sadly we also realized this while attending the EASD conference – many more type 2 patients in Europe take insulin at all, for a start! • Still on devices, he described continuous glucose monitoring as the biggest advance in type 1 diabetes therapy since the discovery of insulin. It provides an important step toward the artificial pancreas for diabetes. Stem cell research/gene therapy, however, could also provide a potential cure one day he says. Dr. Edelman himself has type 1 and we always listen closely to everything he says about diabetes since we know he has an extra incentive to be in the loop! • He ended his presentation on a poignant quote from Larry Verity, an exercise physiologist: “If you cannot find time for exercise, you will have to find time for disease.” He recommended yearly dilated eye exams (retinopathy) , cholesterol panels (LDL, HDL and triglycerides), and regular visits to the dentist (tooth and gum disease). • Dr. Polonsky’s presentation was aptly titled “Psychological Secrets for Effective Self-Management.” The bottom-line message was that diabetes is tough and it is not inhuman to make mistakes – give yourself a break! At diaTribe, we know as well as you do how important it is to find a balance between managing diabetes intensively and having a life outside of diabetes. • Dr. Polonsky likened diabetes management to a job that involved a lot of work, with minimal vacation time and pretty bad pay – boy can we relate to that! He emphasized that diabetes was not a death sentence and elegantly corrected the notion that diabetes is the leading cause of blindness, amputation, and kidney failure. He pointed out that it is poorly controlled diabetes that causes these complications. “Well controlled diabetes is the leading cause of nothing.” He quoted Sir William Osler, who is reputed to have said, “The easiest way to live well is to develop a chronic disease and take good care of yourself.” In Joslin’s 50-year Medalist Study of groups of people who were diagnosed with diabetes 50-60, 60-69 or >70 years ago, researchers suggest that individuals with such long duration of type 1 diabetes may be protected from, or show slower progression to, diabetic retinopathy. The study showed that about 50 percent of the 50-60 year diabetic duration had retinopathy – 44 percent and 27 percent respectively for the 60-69 and >70 years of diabetes. Almost 50 percent of all groups had no significant microvascular complications. These statistics strongly support the idea that a diabetes diagnosis is not necessarily a prediction of severe complications. • Dr. Polonsky described the use of smaller plates as a creative way to monitor and control food intake. He added that focusing on other things – like television – while eating often leads to mindless over-eating. Additionally, it is important to make healthy foods easily accessible and keep the junk stashed away – if not out of the house completely. Learn more about his practice at the Behavioral Diabetes Institute at: www.behavioraldiabetes.org.
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• Ruth Spirakis, a CDE and dietitian, advised diabetes patients to spread carbohydrate intake throughout the day – we know this will help us avoid spikes, though it’s hard to schedule! She emphasized moderation over elimination (okay, good…we weren’t considering elimination anyway!) and urged patients to ask for low-fat or whole grain substitutions while eating out. Check out UConn’s Rate Your Plate game at http://www. sp.uconn.edu/~cthompso/. • Dr. Wargon drew attention to the need for proper foot care for patients. He recommended a foot check on every doctor’s visit, checking shoes before wearing them, and avoiding home remedies and “bathroom surgery” for foot problems. Read more on ADA guidelines to foot care at http://www.diabetes.org/type-2-diabetes/foot-care.jsp

logbook
Summer Camp: Carb Counting, Inspiration, and a Special Torch
By James S. Hirsch

Nurse: “My name is Dorothy, but everyone calls me Bubbles. ” Sheryl (my wife): “Can I call you Dorothy?” Sheryl is a loving woman, but she doesn’t forge intimate bonds with anyone whose name evokes soap suds.

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didn’t quite understand the torch. In August, our family attended the Clara Barton Family Camp in Oxford, Mass. During the rest of the summer, the camp is for girls with diabetes – Camp Joslin for boys is a 10-minute drive away – but for five days in August, across 200 acres of woodlands, hiking trails, and playing fields, Clara Barton is the site for entire families to share bunks, count carbs, have a few laughs, and dry a few tears. About 30 families attended this summer, each typically with a diabetic child who is either too young or not quite ready for a diabetic sleep-away camp. (Many siblings attended as well.) Our son, Garrett, who was diagnosed three years ago, is now 6, so next year, he’ll be old enough for Camp Joslin. But as I said, I wasn’t sure about the torch. The camp has a gift shop, and Garrett bought a string necklace with a nickel-sized pewter ornament. On one side it said: “Barton 1932,” a lovely reminder of the camp’s opening year. Engraved on the other side was a torch, with five tiny stars billowing out like smoke. Did the torch symbolize how the camp is trying to blaze a trail for better care? Or to be a bright light for children with diabetes? Or was it a signal of our strength and vibrancy to everyone around us? Or was the flaming icon suppose to connect generations of patients who at this very camp – and beyond – have passed the torch of empathy, friendship, and love? I suspect Garrett just thought the fire was cool. Regardless, we didn’t have to worry about Garrett fitting in or having fun. He became fast friends with two high-spirited brothers, ages 4 and 6, who shared our cabin – on our first afternoon, the 4-year-old asked Garrett, “Will you be my best friend?” – and they were soon planning post-camp play dates. Which was fine, except we live in the Boston area; and they, in Los Angeles. Each cabin was assigned a nurse, who registered the families when they arrived. Our nurse, a stout woman with short-blond hair, came all the way from Texas. Nurse: “My name is Dorothy, but everyone calls me Bubbles.” Sheryl (my wife): “Can I call you Dorothy?” Sheryl is a loving woman, but she doesn’t forge intimate bonds with anyone whose name
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A long table stood with insulin vials, syringes, and alcohol swabs; and everyone was getting ready to draw up their doses and give their injections. It was all so… normal. My friend told me how for the first time in her life, she was no longer the outsider. So there was only one thing left to do. She wept.

evokes soap suds. Garrett had no such reservations. By the end of the first day, he was running around the cabin, squealing, “I want to blow Bubbles! I want to blow Bubbles!” Camps have a special place in the history of diabetes. The American Diabetes Association now accredits 122 of them, and I don’t know of any other childhood disease in which these “hospitals in the woods” – as they were first called – play such an important role. While the founder of the first camp, Dr. Elliott Joslin, was a visionary, I doubt that even he foresaw what he was bequeathing. After insulin was discovered in 1922, Joslin recognized the value in bringing together diabetic children in a camp setting where they could have fun but also learn the basics of diabetic self-management. While Joslin practiced in Boston, he was raised about 55 miles west, in Oxford, and his eponymous camp was founded nearby in 1927. In addition to medical staff and counselors, it had a laboratory with chemists who tested campers’ urine samples for sugar. In 1932, Joslin joined with the Universalist women to create a camp for diabetic girls, located on the grounds where the late Clara Barton was born. Barton, herself a Universalist, had been a pioneering nurse and teacher best remembered for founding the American Red Cross. One can only imagine the experiences of those diabetic campers so many decades ago. Nowadays, a family with a newly diagnosed child can be instantly connected, through the Internet, to hundreds if not thousands of families going through the same experience. Chat rooms, support groups, blogs – dare I say, even diaTribe – create a genuine community. But 20 years ago, let alone 75, a diabetic child was much more likely to feel isolated, detached, and alone. Except at camp, where all the things that made the child feel different were suddenly the norm. Actually, I don’t need to imagine what those children experienced long ago, because I experienced it myself when, in high school and college, I was a counselor at a diabetic camp in Missouri. In a poignant but typical story, a fellow counselor told me how she had arrived at camp late, and when she drove up, she looked down from a slight hill and saw the entire operation – more than 100 kids – gathered around, talking, laughing, carrying on. A long table stood with insulin vials, syringes, and alcohol swabs; and everyone was getting ready to draw up their doses and give their injections. It was all so . . . normal. My friend told me how for the first time in her life, she was no longer the outsider. So there was only one thing left to do. She wept. As I discovered at Clara Barton this summer, camp has changed a lot since then, just as diabetes has. When I was a counselor, everyone was on the same number of shots (two) and mostly the same insulins (Eli Lilly’s NPH and Regular), and we counselors, ready to save the world, would walk around with our clipboards, holding medical sheets with urine test numbers and a plastic bag with sugar packs for lows. At Clara Barton, the therapies were as different as the kids, who, collectively, had four different types of insulin pumps, at least that many daily injection routines, and God knows how many diets. The counselors were now walking apothecaries, hauling glucose meters, glucose strips, alcohol swabs, tiny lancets, and glucose tabs. The Family Camp cost $250 per person, plus a $50 registration fee. The facilities couldn’t have been nicer, with modern log cabins and dining hall, swimming pool, wellgroomed playing fields, a barn-like theater hall, a conference room, and offices. During the day, the kids had their own activities – sports, swimming, arts and crafts, instruction on health and diet – and even the siblings had special sessions to discuss having a diabetic brother or sister; Garrett’s older sister, Amanda, was one of the attendees. The parents also had break-out sessions. Some were more useful than others. We had, for example, a very good social worker who allowed us to vent our frustrations and who encouraged us to build a support network at home.
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On another occasion, we had a session for yoga. I thought they said “yogurt” so I got there early. The woman kept telling me to relax, but all I could think about were my emails. Disaster.

Garrett Hirsch – Brave “zip-liner” and torch carrier.

On another occasion, we had a session for yoga. I thought they said “yogurt” so I got there early. The woman kept telling me to relax, but all I could think about were my emails. Disaster. Being with so many others and living in such close quarters – there were 15 of us in our cabin, including three counselors – made us appreciate how smart and resourceful other families are. For example, one night at midnight, a girl in our bunk who was on the pump had a blood sugar of about 80 ml/dL – which is a bit risky while sleeping. I thought the parents would try to give her a snack. Instead, they suspended her basal insulin for an hour, slightly raising her blood sugar without disturbing her sleep. Brilliant. We now do that for Garrett. Some ideas were less practical. At one session, a woman with a diabetic daughter spoke to us about her very structured approach on running her household. Using Velcro, she attaches the carb count on every item of food in the kitchen – a depressing thought for those of us who barely have time to put the food away, let alone tally the carbs. But we gave the Velcro woman a lot of credit for her vigor. The camp director asked the parents to stay on the camp grounds, but I will say that five days, on camp grounds, can be a long time. By the third day, I was conspiring with another father, a house painter from Connecticut, to make a jail break for coffee at Dunkin’ Donuts. Some speakers tried to convey how much diabetes care has improved over the years, but the parents, in describing their own fears and heartbreak, made clear how far we have to go. One mother said her child was rejected from a private school because of diabetes. Another mother said her daughter once called 911 to ask for another mommy, because her mommy “was giving her too many shots.” A father recounted how his young son asked, “Who will take care of me if you’re not here?” Another mother said her son is going to help run a lemonade stand so he can find a “curse” for diabetes, so he can eat more carbs. But encouragement came from the diabetic counselors, some of whom spoke to us one night in a break-out session. They talked about their struggles with parents, school, and the entire balancing act of being a young adult and having diabetes. But they’ve all persevered, and they all discussed the indispensable role of camp – “a kick in the pants,” one counselor said, in forcing her to take responsibility for her own health. Camps push you to your limit – “adventure programs” include hiking to the top of Mount Washington in New Hampshire, 6,200 feet above sea level – and create enduring friendships. They also cast a completely different light on a daily struggle. The great thing about camp, one counselor noted, is that “diabetes doesn’t even exist here.” Said another counselor: “I love diabetes, because it’s made me who I am. If there was a cure, I wouldn’t want it.” In college, she wants to major in “recreational service so I can come to camp forever.” For all that camp may have changed over the years, the essentials remain the same. It’s about kids having fun – raising the flag each morning, playing games during the day, singing at the camp fire at night – and being with other kids just like them. One boy told his mother that he liked camp because for the first time, he didn’t have to pull his shirt down over his insulin pump. The highlight, for Garrett, was attempting the “zip line,” in which you strap a harness around your waist, climb 50 feet up a tree, stand on a platform, attach yourself to a cable that stretches between two trees, leap, and hang on as you zip down the line. You can’t really hurt yourself because you’re attached to a rope held by a counselor on the ground. Still, it’s difficult to climb the tree (you put your hands and feet on metal rods nailed across the trunk), it’s not easy pulling yourself onto the platform, and ultimately it requires a literal leap of faith.
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PHOTO COURTESY OF JIM HIRSCH

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Could a little kid like Garrett do it? He pushed on an orange helmet, buckled in, and began his ascent up the tree, taking each step methodically but confidently. He hoisted himself onto the platform, connected himself to the cable, and with his buddies on the ground cheering him on, he jumped as far as he could. The torch, of course, signifies everything – those who carry it are the trail blazers of a poorly understood disease, they’re our beacons of inspiration and courage, and they are the anonymous children who pass the flame of hope to future generations. This I knew as Garrett sailed down the zip line. And just to show off, he inverted his 47-pound body so his toes were pointing toward the heavens. He was back on the ground soon enough, buoyant and fearless, still wearing his torch, heading into the woods at Clara Barton Camp, in search of a wonderful new path.

SUM Musings
Kerri Morrone has been living with type 1 diabetes for almost twenty years. She writes a much-trafficked diabetes blog, Six Until Me (SUM), and is an active member of the diabetes community. She is known for her tagline, “Diabetes doesn’t define me, but it helps explain me.”

When I was diagnosed, my diabetes wasn’t “mine” so much as it was my mother’s. Even though her pancreas worked, she had to act as though she were mine. The numbers on my meter meant something to her. She navigated the wilds of peaking insulins, like Lente and NPH, and she waited patiently for my injection of Regular to slowly bring my high blood sugar down into range.

Twenty-One Years
By Kerri Morrone

Diagnosis T1/2 The first symptoms of diabetes presented themselves when I was a little girl, with the classic bed-wetting. There was no diabetes in my family, so no one thought anything of it. “Maybe she’s just nervous about starting second grade.” The routine doctor’s visit. The urine test. The results. The middle shelf in the bathroom cabinet almost overnight went from holding hand towels to housing ketone strips. Boxes of syringes were piled high, like a diabetes warehouse. The test tubes were in the corner of the bathroom counter, where my mother would perform intricate experiments to see if the sugar content in my urine was too high. People ask all the time what my childhood with diabetes was like – I have to admit that I don’t remember much of a distinction. Asking what growing up with diabetes felt like is no different than asking what growing up in general felt like. My life, as far back as I can remember, has always included diabetes. There has been an evolution in my relationship with diabetes over the last 21 years, though. When I was diagnosed, my diabetes wasn’t “mine” so much as it was my mother’s. Even though her pancreas worked, she had to act as though she were mine. The numbers on my meter meant something to her. She navigated the wilds of peaking insulins, like Lente and NPH, and she waited patiently for my injection of Regular to slowly bring my high blood sugar down into range. My mother and father made sure that there were sugar-free desserts at family picnics, and they fought hard to ensure that their medical insurance covered things like test strips and insulin prescriptions. It wasn’t my battle. I experienced the lows, but I didn’t experience them alone. Regardless of whether or not she could actually feel the shakiness, my parents lived this disease with me. It didn’t become my battle until I realized it was actually there.
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When I was in 5th grade, another classmate had left a note in my locker about how she hated me because I was diabetic. It was the first time I had felt singled out, and it left a stain on my heart.

A Child Learns I became aware of diabetes when I was in middle school. Or at least I remember becoming aware of the fact that I was the only kid in my class who was testing her blood sugar during quizzes. My friends walked me to the nurse’s office when I was low. My parents created classroom “care packages” that explained diabetes, low blood sugar symptoms, and emergency phone numbers, taking every precaution to make sure I felt like a “normal” kid. And I did, for the most part. When I was in 5th grade, another classmate had left a note in my locker about how she hated me because I was diabetic. It was the first time I had felt singled out, and it left a stain on my heart, a dark moment in my memory and one that I haven’t forgotten about, even now, so many years later. I locked it up and kept it close. There were other times when I felt oddly exposed as a diabetic, like when we learned about the pancreas in 4th grade and everyone turned around to look at me when the teacher mentioned “endocrine diseases like diabetes.” There was also the time I had low blood sugar just before lunch, and I had to eat my meal, after draining three juice boxes, in the nurse’s office. Or the time I faked a low to get out of having to perform the obstacle course in front of my classmates in my 8th grade gym class. It wasn’t until I attended a camp geared toward girls with diabetes – Clara Barton Camp in Massachusetts - that I met other kids like me. We compared stuffed animals. We talked about our silly middle school crushes. We also all tested out blood sugars together in the morning, and we took out insulin as a group at night. They, like me, didn’t look diabetic. But they were. Spending summer after summer at CBC as a kid proved that diabetes looked invisible on other kids, too, but it was there. I wasn’t alone. I acknowledged the fact that I was diabetic. And I became comfortable with saying it out loud.
The Adult Emerges Diabetic or not, the teenage years are riddled with expected angst. My battles about boyfriends and pontifications on prom dresses were happening alongside arguments with my mother about rogue blood sugars of 385 mg/dL. Fiercely independent and determined not to be owned by diabetes, or anything for that matter, I took over complete management of my disease in high school. This included gaining my license, which opened double doors of freedom. Like any high school kid, I tested the limits of curfews and curse words, but I also tested the limits of diabetic responsibility. Faced with managing my own numbers and much of my own schedule, I found myself rebelling against the constraints of my condition. I lied about the results on my meter, sometimes dabbing a bit of rubbing alcohol on the test strip to produce a lower result. I visited late-night fast food drive-thrus and drank beer at parties on the beach. Unfortunately, this spiral of rebellion continued into my college years, coming to a frightening peak as a junior, in the midst of my parents’ very troubling divorce and my A1c of over 11 percent. I was confused. I was lost. I was scared and overwhelmed and my frustration with life was taken out on my health. It took a letter from my endocrinologist, addressed to my primary care physician but mistakenly sent to my home, to rip me from my self-destructive path. I opened the envelope and skimmed along ... noting the typed-out elevated A1c, cholesterol levels, and a spike in my weight. I came to a paragraph that was hand-written in that curly, familiar script of my doctor. “Kerri is going through some difficult times at the moment. She spent most of her time in my office on the verge of tears. I am concerned.” It was a cold hand on my hot and tear-streaked face. And it started me on the road back to taking care of myself.
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Like any high school kid, I tested the limits of curfews and curse words, but I also tested the limits of diabetic responsibility. Faced with managing my own numbers and much of my own schedule, I found myself rebelling against the constraints of my condition.

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Owning Up Looking back now, it seems like it happened so quickly. It’s as though I blinked and my A1c dropped from 11-something to 6-something. But it wasn’t an overnight transformation, not by a long shot. There were several months of debilitating low blood sugars. There was one morning when the paramedics were called. There were discussions about the physical and emotional implications of insulin pumping. There was that one phone call to my endocrinologist in the middle of the night – “This is Kerri Morrone. I want to start pumping as soon as possible!” – and there were the long weeks of classes leading up to my transition to pump therapy. There were the many jobs after college where I battled for medical insurance. There was that first afternoon at the gym, followed by another, and another. I took control of my diabetes. I Took Control of Myself. Diabetes didn’t make me smart, but being regimented and dedicated to achieving results on a medical level may have made me work harder in school. Diabetes didn’t make me determined, but it may have contributed to my constant drive toward my ever-changing definition of success. Such perspective is gained from a chronic condition, regardless of its complications. It doesn’t define me, but the strongest parts of my personality may have been gently shaped by the perspective gained from having it. Diabetes didn’t make me love with such ease, but having tasted my own mortality makes every hug, every laugh, every kiss that much more needed and appreciated. I have lived with type 1 diabetes for twenty-one years. Fortunately, I’ve never had to live with it alone. I’ve had the luxury of a supportive family and friends, but hard as they tried to truly understand what it was like, they could only come so close. Two years ago, I Googled diabetes and retrieved a list of possible complications and a few advocacy Web sites in return. Far from my summers at Clara Barton Camp, yet yearning for that same sense of community, I stumbled upon a handful of people with diabetes who were writing blogs. I devoured every word, and then felt inspired to start my own. Writing about diabetes, sharing my experiences and emotions with people who have felt similarly, has made such a difference. Not feeling alone has helped me fully accept diabetes as a part of me, one that I can live with in relative harmony.

Diabetes didn’t make me love with such ease, but having tasted my own mortality makes every hug, every laugh, every kiss that much more needed and appreciated.

Glo’s diaTribe
Gloria Yee, RN, CDE is a certified diabetes educator at the Diabetes Teaching Center at the University of California San Francisco. Her clinical focus is diabetes technology. Gloria has type 1 diabetes.

It’s All in Your Head
By Gloria Yee

T1/2 living with it, it has been integrated into my daily life. I don’t really think about it…
Or do I? Just how much time and effort is spent on diabetes? On a normal day, I test about 9 times. It takes my meter 7 seconds to provide a reading. I can whip out my meter, prick my finger, and have my blood sugar result in less than 1 minute. (It takes longer to locate my meter. Why do they always make the case black?) That’s nine minutes, let’s round it up to 10. How about counting my carbs? That averages
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I have always recognized that diabetes is a big part of who I am. After 20 years of

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Wow...that’s kind of overwhelming. I’ve never seen it quite like this before. This mental checklist of to-do’s – I’m surprised it hasn’t taken over my life! No wonder I’m tired at the end of the day. No wonder there’s a book called Diabetes Burnout.

to about 30 seconds per meal. If I did that 6 times per day, that will be 3 minutes. Let’s round that up to 5. Then there’s the button pushing to deliver my insulin. Once again, 30 seconds times 6, that will be 3 minutes. Round up again to 5. 10 + 5 + 5 = 20. Twenty minutes? That doesn’t seem right. I must spend more than 20 minutes a day doing diabetes stuff. It certainly feels like it’s a lot more time! During a recent diabetes workshop, my patients and I were discussing the above. Those were just the visible chores. There’s got to be a lot more! There is, and we came up with the following list: 1) Check blood sugar 2) Count carbs 3) What kind of food? High fat? High protein? 4) Insulin on board – How much? How long? 5) Activities – Any physical activity coming up? Or just finished? 6) Health assessment – Am I feeling okay? Any recent lows? 7) Mental assessment – Am I upset about something? Would that affect my blood sugar? 8) Deliver insulin 9) Record keeping – I have to write it down or else I’ll forget. 10) Problem solve high & low blood sugars 11) Access to all diabetes supplies on person – Do I have enough test strips? Do I still have candy in my purse? 12) Appointments – Am I due for a check-up? Eye exam? 13) Prescriptions – Am I running low on supplies at home? How many infusion sets do I still have? How many vials of insulin? Will the insurance allow more test strips? Wow…that’s kind of overwhelming. I’ve never seen it quite like this before. This mental checklist of to-do’s – I’m surprised it hasn’t taken over my life! No wonder I’m tired at the end of the day. No wonder there’s a book called Diabetes Burnout. What am I going to do about this, this THING, this MONSTER, this list I’ve created? First, I’m going to meditate more. Second, I’m going to thank my family. I know they share some of this mental burden. Third, I’m going to print out the list, and keep it in a visible place in my office. My respect for living with diabetes grows. Fourth, ummm, I think that’s enough lists for the day.

test drive
A short page from my Alli Diary
By Alisa Bekins

T1/2 approved the first ever over-the-counter weight loss drug, orlistat
(Alli). It was first approved in 1999 (then called Xenical) for prescription use only – sales didn’t take off the way they were expected perhaps due to side effects. Now that the drug is available in an over-the-counter form, it has been flying off the shelves. Alli is sold in 60 mg capsules—half the dosage of Xenical, at a cost of about $50 for a one month supply. Here at diaTribe, our Director of Operations, Alisa Bekins, has been on Alli for two months, and she shares her experiences with us below. Rationale: As I stare into the mirror, I wonder what I have been thinking for the past six years. I was 40 pounds lighter then, and my back problems were intermittent. Now, my

In February 2007, the Food and Drug Administration (FDA)

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back problems are limiting me to walking for exercise. This is a wakeup call for me. I am going to go on a serious diet, supplemented by Alli. Week 1 – Mental Management: Taking Alli requires some getting used to. I have to get used to taking three pills throughout the day and one in the evening. I’ve programmed my Blackberry to remind me so that I don’t forget. The biggest challenge has been changing my diet. In order to reduce the risk of the notorious gastrointestinal side effects, Alli users are advised to severely restrict the consumption of fat. I’m eating only about 1,200 calories a day- down from 1,900 calories a day. I’m also walking for about an hour a day. Week 3 – Going steady: It’s only been three weeks, but I can already see results! I’ve lost about 9 pounds total. I have to admit that it’s becoming easier to stay focused. Surprisingly, I have no side effects even though I heard a lot of stories of bad side effects from people on Xenical – I think it’s because I’m following directions and I’ve been eating a super low-fat diet. To be honest, I’m scared about what will happen if I deviate from a low fat plan, especially if I’m eating out at a restaurant – what could possibly be worse than a bathroom emergency in a restaurant? I’m sticking to salads Week 8 – Results: I’m 22 pounds lighter and down two sizes of jeans since started! I doubt I can keep this up. I now weigh myself every Monday in the morning. Although I’m delighted with my progress, I have to wonder how much of the weight loss is caused by Alli, and how much of it is caused by my behavior ... — More to come on new combination drugs to fight obesity when our neuroscience expert, Mark Yarchoan, tells about the recent Obesity Society Conference in New Orleans.

Profile
Stephen Covey and the 7 Habits of Highly Effective People with Diabetes
An international authority on leadership, family, and organizational values, Dr. Stephen R. Covey is perhaps best known for his self-help book, “The 7 Habits of Highly Effective People.” Less well known is that his wife has diabetes. He was hired by Bayer to write “The 7 Habits of Highly Effective People with Diabetes.” Visit http://www.diatribe.us/ issues/6/profile.php to read the whole story.

7 Habits of Highly Effective People with Diabetes
1. Be Proactive. Choose your actions and take responsibility for them. 2. Begin with the End in Mind. Create a vision for you life, based on what is more important to you. 3. Put First Things First. Prioritize your tasks based on what is truly important. 4. Think Win-Win. Build strong relationships with others by helping them succeed as well. 5. Think First to Understand, then to be Understood. Listen with your mind and heart, then make yourself understand. 6. Synergize. Build relationships with others to help you make progress in every area in life. 7. Sharpen the Saw. Keep all parts of yourself sharp: physical, mental, social, and spiritual.

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trial watch
Study comparing the safety of Insulin VIAject and Regular Human Insulin in type 1 patients and type 2 patients. http://www.clinicaltrials.gov/ct/show/NCT00542724;jsessionid=F080ED2E3C4A9435E 5324239F49256BA?order=2 - Type 1 study http://www.clinicaltrials.gov/ct/show/NCT00542633;jsessionid=F080ED2E3C4A9435E 5324239F49256BA?order=1 - Type 2 study The purpose of these two trials is to see how Biodel’s Insulin VIAject stacks up against regular human insulin (Humulin) based on the degree of their effects on A1c in type 1s and type 2s respectively. Early data suggests that VIAject, the ultra rapid-acting form of injectable human insulin for mealtime use currently being tested, may allow better mimicking of the action of insulin in non-diabetics. Each study is looking to enroll 400 patients between (18-70 years) who have been diagnosed with diabetes for at least one year and have A1c values of under 10.5 percent. The type 2 study will be conducted in California, Delaware, Florida, Georgia, Louisiana, Maryland, Massachusetts, New York, Texas and Washington. Please contact 1-888-5246335 (provide reference NCT00542633) for more information. The type 1 studies will be conducted in multiple centers in California. Please contact 1866-322-0041 (provide reference NCT00542724) for more information.
T1/2

Joslin’s 50 year Medalist study This is a great opportunity for people who have been living with insulin-dependent diabetes for over 25 years. The Joslin Diabetes Center has a program to recognize people who have been on insulin for 25, 50 and 75 years and to celebrate their commitment to diabetes management. In particular, 50 year medalists are invited to participate in a study to help researchers assess which factors in the blood (if any) affect a patient’s risk for developing complications. For further information, please contact the study coordinator, Alysha Berger, at 617-713-3481 or email her at alysha.berger@joslin.harvard.edu. You can also visit http://www.joslin.org/733_Medalist.asp to learn about how to nominate yourself or someone you love for a medal. Remember, you do not have to be a Joslin patient to participate.
T1/2

Obesity and Diabetes Prevention Through Science Enrichment (DKENERGY) http://clinicaltrials.gov/ct/show/NCT00541879?order=14 You have heard it from your physician, you have heard it from your educator and you will keep hearing it from diaTribe; adoption of healthy lifestyle changes can prevent or reverse type 2 diabetes and obesity. The aim of this study is to see if elementary school children can be equipped with the knowledge and the skills to prevent these two conditions. It will look primarily at diabetes knowledge and prevention behaviors in children after one to three years of education. What an excellent study! As a secondary outcome, the study will see the children shift their knowledge to their parents. It is being sponsored by Colorado State University and is recruiting 1,000 participants. It is expected to be completed by September 2009. The children should be between 6-13 years and need not have any metabolic conditions. Please contact L. Arthur-Campfield, PhD, on 970-491-3482 or at campfield@cahs.colostate.edu or Francoise Smith, MS on 970-491-7889 or at fsmith@cahs. colostate.edu for more details.
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what we’re reading
Run, Don’t Walk, to Pick Up The Little Diabetes Book YOU Need to Read! We strongly encourage you to go pick up The Little Diabetes Book YOU Need to Read. This quick-reading, constructive book will serve you well in devising or refining your diabetes game plan. The authors are a fabulous team - Martha M. Funnel, a well-known diabetes educator at the University of Michigan, and Michael A. Weiss, a type 1 businessman who has been a past chair of the ADA. They are clearly friends and by the end of the book, you will feel like they’re your friends too. Throughout the volume, little, gray boxes feature “Marti speaks” and “Mike speaks,” offering personal highlights from the two. You look forward to these as they help refine your care. The authors’ personal experiences with diabetes are vast, and I found their insights constructive in helping refine my own plan. The book’s core is the authors’ top four life steps for living with diabetes - a highly condensed, but still helpful, blueprint. #1: Learn all you can about diabetes and yourself. That means learn not just the facts, but also learn more about yourself and what you can take on, your feelings, desires, needs, what will make you feel more in control, and what you can manage. #2: Identify the three guiding principles: role, flexibility, and targets. We loved reading about the role of the patient from the authors’ perspectives - they are all about self-management and they urge patients to consider the extent to which they want to manage their diabetes. Knowing this is possible is terrific. Also, we loved seeing flexibility and targets in one sentence - we learn that targets are critical, but that they are a starting point and that we as patients can gain even more flexibility in exchange for a little more work. The authors talked about targets in terms of not just diabetes but also blood pressure, cholesterol, and weight - lest we forget! #3: Formulate your self-management plan. They go through the “how” of self-management and demonstrate how to develop a solid game plan - I wish I had read this 20 years ago! #4: Experiment with and evaluate your plan. This is more about flexibility and about working toward targets creatively - it was terrific from our perspective to see the experts urge this. Mike’s words in particular really resonated – he learned through “trial and error – mostly error!” Our favorite part of the book was the last chapter, titled Staying the Course – it’s all about the realities of diabetes - reading this made me feel quite motivated about what I could do to improve my care - thanks so much to these authors.
T1/2

IMAGE COURTESY OF MARTHA FUNNELL

Look out for the “Marti speaks” and “Mike speaks” gray boxes throughout the text of this terrific volume

My TCOYD Newsletter • For the remainder of the Taking Control of Your Diabetes (TCOYD) conferences this year, diaTribe subscribers will receive an exclusive 10 percent discount on the participant registration fee! Please call 858-755-5683 or 800-9982693 to obtain your discount. The more people you sign up, the better the discount gets so bring friends! The next conferences will be in Milwaukee on November 17, and then of course there is the monumental San Diego conference on December 8. • The TCOYD conference was founded and is currently directed by our very own advisory board member, Dr. Steve Edelman. Dr. Edelman is an incredibly respected thought-leader in diabetes treatment, research, and education who knows first hand what it means to live with type 1 diabetes. Every three months, he releases an excellent publication called My TCOYD Newsletter, with some fascinating stories often involving his own patients. Here, we highlight last quarter’s issue of My TCOYD Newsletter.
T1/2

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For the remainder of the Taking Control of Your Diabetes (TCOYD) conferences this year, diaTribe subscribers will receive an exclusive 10 percent discount on the participant registration fee! Please call 858-7555683 or 800-998-2693 to obtain your discount.

• In the last six months, there has been much ado about the FDA and its involvement with GSK’s Avandia, Takeda’s Actos, Abbott’s Navigator, Amylin’s Byetta and Symlin, and Merck’s Januvia. In some cases the FDA has been slammed for not being thorough enough while it has also been lambasted for dragging its feet in the regulatory process. Dr. Edelman writes a fair and objective piece discussing the FDA review processes. He describes the Research and Development (R&D) process using a colorful analogy for drug development: “ Developing drugs is sort of like the restaurant business; for every ten new attempts, only one is successful.” He describes the progression from animal studies to drug testing in humans and submission of hordes of data analysis to the FDA. New Drug Applications (NDAs), he quips, are more of a pain than filing taxes and involve enough paperwork to require the services of a delivery truck. Even after the FDA approves a drug six to twelve months later, the battle is not won. The quality of the manufacturing plant must also meet FDA standards of sanitation and production. The facility may have to be prepared even prior to drug approval – an investment flushed away if the drug is not approved. He concludes with a grateful nod in the direction of pharmaceutical companies in saying, “It is important to understand the complexities of drug development and to have an appreciation of what it takes for a pharmaceutical company to bring an advance to the pharmacy shelves.” • One of the highlights from this edition was the frank and often humorous interview with Dr. John Buse, president of the American Diabetes Association as of September 2007. The interview kicks off with a very funny anecdote about Dr. Buse’s first ADA conference as a boy (his mother is a researcher). Bored from the adulttalk at the meeting, the 12-year-old wandered off and was found “standing on tip-toe, peering through a paint-stripped patch on the window of a strip club.” In talking about his practice, Dr. Buse described his role as searching for complications and thinking creatively to help patients overcome particular issues. “Education immunizes patients from less than excellent medical care,” he said. “If patients know what they need, they can find a doctor who can help.” Dr. Buse was drawn to diabetes after contact with their plight during medical school and residency. At a time when syringes required boiling and sharpening and diabetic complications ran rampant, Dr. Buse took on the disease as a challenge, following in his parents’ footsteps. At the end of the interview, he emphasized the need to extend the capabilities of primary care physicians given the shortage of endocrinologists. We loved his concluding definition of a good primary care physician as someone who can take charge of their patient and concurrently recognize when a specialist needs to be called in. If you see a primary care doctor, you might ask him or her at what stage of your diabetes or in what circumstances he might suggest you see a specialist. • In a brief advice segment called Know Your Numbers, Dr. Edelman stresses the importance of recognizing trends in your blood glucose readings during periods that you and your health care team have recognized as periods of good management. As such, you will be better able to catch blood glucose trends that seem to be straying. This would be a great way to put yourself in the driver’s seat and prompt conversations with your health care provider to address your concerns. He adds that it is important to record unusual circumstances that you think accompany any unusual blood glucose results. • TCOYD TV comes on four times every month and reaches 11.5 million viewers per each broadcast, plus online access. With one season under their belts, Dr. Edelman and his team are working to bring you an outstanding second season covering hypoglycemia, pregnancy, skin issues and sleep disorders related to diabetes. Season one covered burnout, practical approaches to exercise, diabetes and the law, and our favorite episode, “Food is not a four letter word.” See the programming schedule, links to all episodes as well as cable schedules by visiting http://www.ucsd.tv/schedule/index. asp?keyword=13444. Please send questions/comments to info@TCOYD.org.

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NewNowNext
Update on the Changing Diabetes Bus We wrote about the bus in Issue 5 of diaTribe (http://www.diatribe.us/issues/5/ new-now-next.php) when we saw it at the ADA meeting in Chicago. We crossed paths with it again when we were at the EASD conference in Amsterdam and at ISPAD in Berlin. We learned that it was just coming from Baltimore and will proceed to the U.K. and Ireland and be in New York City in time for World Diabetes Day. The goal is not only to spread awareness but to carry out diabetes/prediabetes screenings as well. Over 16,000 people have already been screened on the tour, and the bus has had over 73,000 visitors, as of the end of September. Check it out at: http://diabetesbus.novonordisk.com/Diabetes/DiabetesBus/frontpage-default.asp
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IMAGE COURTSEY OF BIOSECTOR2

IMAGE COURTESY OF PATTON MEDICAL DEVICES

Patton Medical Devices I-Port A smart innovation, the I-Port acts as an insulin delivery channel directly through subcutaneous tissue. Once the I-Port is applied, you can then use a needle or insulin pen to deliver insulin or Symlin or Byetta without the need for new shots to the skin. The needle stays above the skin and the I-Port delivers through a small channel. A single patch can take 75 injections and can be worn for 72 hours. It is also small enough to be hidden under clothing and pledges to limit bruising and increase compliance to injection therapy. The I-Port is available by prescription. Patton Medical also provides demos and information at: http://www.pattonmd.com/product/howitworks.php.
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Cube up your food Here’s a potentially elegant little invention that might make portion control easier: food storage trays with pre-sized cubes to help you measure, freeze and store your food in precise amounts and keep track of exactly how much you’re putting into a meal you’re cooking or how much you’re eating. The 32-ounce trays are available individually or in a set of three, with cubes divided into two-cup, one-cup or half-cup portions. We see this as innovative, yet simple. It could be very helpful in carb counting by improving the accuracy the age-old tradition of SWAGing (scientific wild-ass guessing) the number of carbs in a portion.
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diaTribe publishes information about diabetes products and research. This information is not a substitute for medical advice and should not be used to change treatment or therapy. diaTribe urges readers to consult with professional care providers in all matters relating to their health.

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