DIA4RIBE - diaTribe 15 - Mar_Apr 2009.pdf · news, SymCare’s inTouch program, CGM reimburse-ment,...

I S S U E 1 5 • M A R C H / A P R I L 2 0 0 9

From the Editor ...............1

Quotable Quotes ............2

Test Drive (#1)..................2The new DexCom SEVEN PLUS

Test Drive (#2)..................5The Tethys prediabetes risk test

Learning Curve ................7Explaining anti-CD3 re-search for type 1 diabetes

Conference Pearls ...........10The 2008 ATTD meeting for diabetes device research

New Now Next ...............13 Recent FDA approval news, SymCare’s inTouch program, CGM reimburse-ment, the Tour de Cure Red Rider program, and the end of the Deltec Cozmo

Logbook ...........................16The Marathon Mom

Thinking Like a Pancreas 17Are you using G.I. Joe?

Trial Watch ......................19Bariatric surgery for type 2 diabetes and trials of two new type 2 drugs

in this issue

research and product news for people with diabetes

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®

from the editor

We’re glad to be able to celebrate a truly momentous season for people with diabetes. I’m referring to President Obama’s recent step to repeal limits on federal funding for embryonic

stem cell research, which opens the door for scientists to intensify their studies of alternative therapies like the creation of new islet cells for transplant. We’re confident that this increased research will help to

improve the lives of people with diabetes giving both patients and doctors another ‘tool in the toolbox’ for diabetes care.

While I’m on the subject, this month brings us the arrival of another highly anticipated tool for diabetes management—the next generation of the DexCom SEVEN! The new model (called the SEVEN PLUS) brings with it a host of important improvements over the old. Personally, I’m particularly excited about the new trend arrows, which are incredibly helpful to have from both the everyday management perspective and the long-term treatment optimization perspective. I also love the alarms for high and low and the 24 hour trend line, which somehow make me a little more disciplined about what I’m eating! It’s great to see so much progress with CGM, and in diabetes technology broadly. Take a look at this issue’s Test Drive for my personal experience with the SEVEN PLUS.

Thank you for all your feedback in our recent survey. It was so helpful to get your views and we’ve been busy integrating them. For example, you told us you wanted more of Test Drive and New Now Next -- in this issue, New Now Next is longer than usual and there are two Test Drive Columns -- the second is from my friend Amy on an excellent new prediabetes risk test from Tethys Bioscience. Now personally I wish I could take this! But I’ve firmly got type 1 diabetes through and through. The Tethys test examines risk for type 2, and in this day and age, almost everyone knows someone who might be at risk for developing type 2 diabetes (a sibling? child? parent? friend?). This test can help you find out a person’s chances of developing the disease in the next five years. Type 2 diabetes can be delayed or prevented with proper diet and exercise, so hopefully this test can help motivate those at high risk to improve their health. We’re giving away five free Tethys tests this month--to enter the giveaway, go to www.diatribe.us/tethystest.

Yours truly,

Kelly L. Close

To get your free subscription to diaTribe, visit www.diaTribe.us.

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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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diaTribe staffEditor in ChiefKelly L. Close

Managing EditorsKaku ArmahBrendan Milliner

Senior Advisor James S. Hirsch Contributors Daniel BelkinDana Lewis Gary ScheinerKerri Morrone Sparling Anita LyonsEllen UllmanNick WilkieAmy D. Baker

diaTribeadvisory board

Dr. Richard Bergenstal, MD Jennifer Block, RN, CDEDr. Zachary Bloomgarden, MDDr. Bruce Bode, MDDr. Nancy Bohannon, MDDr. Bruce Buckingham, MDDr. Wendell Cheatham, MD Dr. Steven Edelman Dr. Barry Ginsberg, MD, PhDJeff HalpernDr. Lutz Heinemann Debbie Hinnen, CDEDr. Irl Hirsch, MDJeff HitchcockDr. Lois Jovanovic, MDDr. Francine Kaufman, MDDr. David Kendall, MDDr. Aaron Kowalski, PhDDr. Harold Lebovitz, MD, PhDLinda Parks, CDEDr. William H. Polonsky, PhDMichael RobintonGary Scheiner, MS, CDEJane Jeffrie Seley, NP, CDEDr. Jay Skyler, MD Dr. Paul Strumph, MD Dr. William Tamborlane, MDVirginia Valentine, CDEDr. Howard Wolpert, MDGloria Yee, RN, CDEDr. Paul Zimmet, MD, PhD Dr. Bernard Zinman, MD Dr. Howard C. Zisser, MD

quotable quotesA Technology in Evolution“I can see the day when accuracy will be sufficient that regulators will accept that CGM values can be used for clinical decision making, that factory calibrations will be possible, that reimbursement will be a foregone conclusion, and that usage will be routine so that all patients and providers will need to know how to accomplish it.”

— Jay Skyler, MD (University of Miami Miller School of Medicine, Miami, FL) noting a bright future for CGM use.

Bringing Back Science“At this moment, the full promise of stem cell research remains unknown, and it should not be overstated. But scientists believe these tiny cells may have the potential to help us understand, and possibly cure, some of our most devastating diseases and conditions. To regenerate a severed spinal cord and lift someone from a wheelchair. To spur insulin production and spare a child from a lifetime of needles. To treat Parkinson’s, cancer, heart disease and others that affect millions of Americans and the people who love them.”

— President Barack Obama remarks during the signing of the Stem Cell Executive Order and Scientific Integrity Presidential Memorandum in Washington, DC on March 9, 2009.

Plans for Health“Any program that helps people with diabetes improve their control and rewards them for doing the right things is encouraging.”

— Martin Abrahamson, MD (Joslin Diabetes Center, Boston, MA) supporting the new health plan from UnitedHealthcare that provides extra financial and coaching support to individuals with diabetes or at risk of developing diabetes.

fingersticks

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test drive (#1) The DexCom SEVEN PLUST1/2

by Kelly Close

We last wrote about using the DexCom SEVEN continuous glucose monitor (CGM) in Test Drive of diaTribe Issue 5 (http://www.diatribe.us/issues/5/test-drive.php). Since then, DexCom has come out with its next generation CGM device called the DexCom SEVEN PLUS. As a reasonably faithful DexCom user (I’ve had my flirtations with other CGM systems historically), I was excited to be able to test the new SEVEN PLUS. The handheld still looks like the old SEVEN system, and the change in the new version mostly pertains to new software features.

Trend arrowsThe biggest and most exciting change for me is the introduction of rate of change arrows. These have been available on the Medtronic Paradigm and Abbott Navigator CGM systems and it was only a matter of time before they appeared on the DexCom system. These arrows give you a quick idea of where your glucose levels are headed, and how fast they

are changing. They make me much much smarter about what I eat (Tartine Bakery sees me less often) and how I exercise (such as it is), etc. There are seven types of arrows to describe whether your glucose is fairly stable (changing less than 1mg/dl/min) or increasing rapidly (changing more than 3 mg/dl/min) or moderately (changing between 1-3 mg/dl). For some context, a rate of decrease of 2 mg/dl/min means that after one hour, your glucose levels could drop 120 mg/dl! With an arrow like that, there’s no telling twice to test and treat if necessary. DexCom is the first system to offer information on rates of change of more than 3 mg/dl/min.

Alerts, alerts, alerts!The SEVEN PLUS has a number of new features including new 6-, 12-, and 24-hour screens in addition to the original 1- and 3-hour screens. You can now put in event markers for every-day things like food, insulin, hypoglycemia symptoms, alcohol, illness, stress, and different intensities of exercise. These options allow users the opportunity to incorporate a lot of “real-life” data that could make visits with educators and physicians all the more fruitful. I very, very much like the meal and insulin markers and use them all the time. While I don’t use all these alerts, it’s comforting to know

that they are there if I decide to use them.

Menu driven displaysYou know how inadequate your own phone can feel if you walk into an Apple store and try out the iPhone? That’s just about how it feels comparing the easier navigation on the SEVEN PLUS to the old SEVEN. It used to take multiple clicks of the down arrow to get to the 3-hour graph menu. Now it only takes a couple of clicks, which to me means that there’s a lower barrier to interacting more with the device. In addition, it’s much easier to insert blood glucose values for calibration (allows a new sensor adjust itself to your body so it can deliver accurate glucose trends) – just a couple of clicks and you are done.

A diagram of the different

trend arrows on the SEVEN

PLUS

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Less obtrusive transmitterWhile the size of the transmitter has not changed, the new transmitter sports a grey color, which blends in with light colored clothing much better than the previous black transmitter. What I would really love to see is a change in the color of the white adhesive tape that keeps the transmitter and sensor in place. I would go for transparent tape, ideally. It’s nice to have a less prominent transmitter, but it doesn’t help if the tape is obvious under clothing.

Suggestions for improvement

1. It’s still a little painful to insert for me personally, though less than it used to be.The system uses a 26-gauge needle, which is the smallest of all the systems, but maybe it’s just the manual action –I know many who don’t mind it, but for me, I’d love something I can feel even less!

2. Rate of change alarms could be even more customizable. Personally, I’d like to have an alarm when my sugar’s changing at 2 mg/dl/min AND 3 mg/dl/min—the new sensor has both, but you have to choose one or the other. And yes I realize not everyone wants all this information – but I’d like it so I know what food really hits my system the fastest. Right now, though, I have it on 2 mg/dl/min because I do want to make sure I turn the insulin on when I see this alert.

3. I’d like to see bluetooth connectivity for downloads. The WaveSense Jazz Wireless blood glucose meter has this ability – though it’s not yet approved - and it would be great to see it transferred to continuous glucose monitors. Having this capability would make the download process much simpler since it wouldn’t involve time spent looking for lost cables, or disconnecting other USB devices.

4. Please make the next DexCom compatible with my Mac. Seriously these are the two devices I use most and it would be great if they could “talk” to each other without the need to download complicated Virtual PC software like Parallels.

Overall impressionsI’m very optimistic about the SEVEN PLUS. I think that however much I loved the SEVEN, the SEVEN PLUS really represents a great improvement over the first-generation SEVEN, and both the trend arrows and the rate of change information in particular are big steps. I’ve found that the trend arrows really help me to improve my management—I got really good at not checking my blood glucose after eating cake, and then I got good at not looking at my CGM for 9 hours, but it’s awfully hard to ignore two arrows straight up (as long as you’re looking at your CGM)! It’s good for DexCom that they’ve integrated this feature, and now patients can get trend arrows regardless of the CGM brand they choose.

How you can get a SEVEN PLUSIf you are a SEVEN user and your current system is still under its 1-year warranty, DexCom will give you an upgrade for a reduced price of $199, and even if your warranty has expired, your insurance may well cover the new system. Otherwise, right now DexCom is selling the new system for a special introductory cash price of $799. If you’re not a current DexCom user, speak to your healthcare provider about a prescription. See this issue’s NewNowNext for more information about which insurance plans currently cover CGM.

“However much I loved

the SEVEN, the SEVEN

PLUS really represents

a great improvement

over the first-generation

SEVEN.

-Kelly Close

The handheld of the SEVEN

PLUS, showing the graph

screen and new trend arrow

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test drive (#2) The Tethys pre-diabetes risk test T2

by Amy D. Baker

The number of factors involved in type 2 diabetes makes it hard to talk about the risk of diabetes without talking about blood pressure and cholesterol in the same breath as blood glucose, LDL or HDL cholesterol, or insulin. The PreDx Diabetes Risk Test, created by Tethys Bioscience, applies that logic to the laboratory. This test measures seven biomarkers (chemical measurements of biological processes underlying type 2 diabetes) in order to calculate a risk score for developing type 2 diabetes within five years, on a scale of one to ten. diaTribe requested to test the PreDx test and Tethys was kind enough to offer us four free samples. People who take this test are characterized into three groups: low risk, moderate risk, and high risk. Individuals with low risk have a Diabetes Risk Score less than 4.5; those with moderate risk have a score greater than 4.5 but less than 8.0; and people with a score greater than 8.0 are considered to be at high risk.

We recruited a number of long-time friends of diaTribe, including Amy D. Baker, who leads this issue’s Test Drive. None of the participants had been diagnosed with either type 1 or type 2 diabetes at the time this article was written.

Amy Baker’s initial thoughtsThus far, adults I know who have revealed to me their type 2 diagnoses have also been found to have high blood pressure, central adiposity (that means they have extra weight around their abdomen), high body mass indices (BMI’s), and other such risk factors for metabolic and heart disease.

I would not have originally identified myself as at risk, but my bravado was cracked a little when a friend and I took the type 2 diabetes risk assessment published by the Finnish Diabetes Association (http://www.diabetes.fi/english/risktest/#). His score was lower than mine despite differences in BMI that I thought should have given me an edge. The fact that my father has been diagnosed with type 2 bumps me into a higher risk category, and I decided to stop leaning so hard on BMI and body shape as my leading indicators.

When diaTribe offered a select few of us a chance to take the PreDx test we jumped at it, each for our own reasons. In my case, I wanted to know if this should be higher on my list of things to worry about than it is currently. I am a professional woman in her mid forties raising a young child. Between my Blackberry and bath time there truly isn’t a lot of time to spare and I have stripped my life of all clutter and extraneous activities. This includes worrying about things I don’t need to. For the others, it was a combination of curiosity, age, ethnicity and awareness of the type 2 epidemic that drew them to it. One member of the group mentioned that he was nearly at the age at which his father had his first heart attack, adding that both his mother and brother had chronic high blood pressure.

Existing tests for prediabetesI knew from my work as a marketing consultant that there were three main ways you can currently test for pre-diabetes and they all have flaws. The three ways are:

Fasting glucose: Specific, convenient, but not sensitive. Essentially, this means that a glucose result between 100 – 125 mg/dl puts you firmly in the prediabetes camp, but there

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“In my case, I took the

test because I wanted

to know if [diabetes]

should be higher on my

list of things to worry

about.

-Amy Baker

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are many people who may still have good control of fasting glucose but poor control of glucose after meals, who would not be recognized using just this test.

Oral Glucose Tolerance Test (OGTT): Specific and sensitive, but inconvenient. In most cases a blood glucose level above 140 mg/dl will accurately let you know that you have impaired glucose tolerance. However, this test takes at least two hours to perform and possibly additional time to analyze the results.

A1c: Not specific, but sensitive and convenient. The test does not always accurately reflect glucose control particularly in recently diagnosed people. On the other hand, it is easily administered in the doctor’s office and results are readily available.

Despite the various flaws in each of these tests, when used collectively, they offer a much better picture of one’s glycemic control. At separate times I have had the first two tests but not the third, and was curious to know what was better about the PreDx test. My assumption was that any diabetes risk test has got to be more sensitive, specific, convenient and affordable to trump tests we have already. I am delighted to report that the PreDx test covers all these bases with one exception – cost. It is sensitive, specific, convenient, and includes an added bonus of giving you information about your risk of developing diabetes in the next five years.

Risk of type 2 diabetesIn my case, the test told me that my risk for type 2 diabetes was low and I went home convinced I should focus on health improvements for a host of other reasons. I am not sure I would have paid out of pocket for this test, or even that I would foot the bill at its current pricing (~$750) in five or 10 years. I would certainly take it again once insurance companies begin to cover it and the cost is diminished to the cost of my normal co-pay for lab tests.

There is a current debate over the usefulness of telling a person that they are at risk for type 2 diabetes. It is difficult to make the necessary lifestyle and dietary changes needed when faced with such a diagnosis – let alone a risk of developing it in five years. I find that knowledge provided by this test is a gift, and knowing that I can be proactive about something to which most people would have had to react should be seen as a gift as well.

But I like knowing that there is an easy way to rule out the possibility of getting an unannounced, asymptomatic and painless disease that causes long-term complications if left unmanaged. There are so many things we do NOT get to affect in our lives, that the chance to know what you’re up against and tackle it early seems like a worthwhile investment. If some of my risk factors change, I will be back in their lobby, asking for another.

Who should take this test? My colleagues with whom I shared this Test Drive experience had quite a bit of input in terms of ideal candidates for this test. Some believed that there probably wasn’t much use in doing this test if neither you nor your physician believes you could be at any increased risk for diabetes or prediabetes (e.g., no family history of diabetes, normal blood pressure, normal cholesterol, normal blood glucose, not overweight etc.). Interestingly, though, over 25% of Americans have high blood pressure, over one third have high cholesterol, and a whopping two thirds of Americans are overweight. So… if you don’t have any risk factors that is great! But if you do, our group thought that the test might be useful, especially if you have a family history and one of the other risk factors. People who have been diagnosed

“The chance to know

what risks you’re up

against seems like a

worthwile investment.

I would certainly take

the test again once

insurance companies

begin to cover it.

-Amy Baker“

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with the metabolic syndrome or with prediabetes would greatly benefit from the test as a concrete justification for implementing lifestyle changes.

What about insurance coverage? We understand that the decision for an insurance company to cover a predictive test like this relies on whether or not they think that investing in this test will save them money down the road. The only way to figure that out is to see how many people actually do take action once they know they are at increased risk for diabetes. The rationale here being that the earlier you take action, the healthier you remain, and the fewer medical procedures that insurance companies must pay for.

If you would like to learn more about the test, go to http://www.tethysbio.com and click on “PreDx Testing.” In addition, diaTribe is offering five free tests in this month’s giveaway -- go to www.diatribe.us/tethystest to enter.

learning curve Anti CD-3: Stopping Type 1 Diabetes As It HappensT1

by Mark Yarchoan

What if type 1 diabetes could be turned-off right when it begins? This sounds like science fiction, but for over 25 years researchers have worked to understand how type 1 diabetes happens, in the hopes that the disease can be stopped immediately after it is diagnosed. These efforts may finally be bearing some fruit.

Although type 1 diabetes is likely to remain a life-long diagnosis in the foreseeable future, there is a new type of therapy is in clinical development that may slow the disease’s progression after it is diagnosed. This may prevent or delay the full-blown disease. The treatment, called an anti-CD3 monoclonal antibody, may make type 1 diabetes more manageable for people who are newly diagnosed and it offers hope that someday there may be a cure for type 1 diabetes. (It is not being tested in type 2 diabetes or in people with established diabetes.)

The Science Behind Anti-CD3Nobody completely understands what triggers type 1 diabetes, but scientists have learned that the disease is brought about when the body’s own immune system mistakenly attacks specialized cells in the pancreas, called beta-cells, which produce the hormone insulin. By the time type 1 diabetes is typically diagnosed, approximately 80% of beta-cells have been destroyed. This auto-immune destruction of pancreatic beta-cells continues until the person becomes completely dependent on insulin injections.

If the immune system could be stopped from destroying beta-cells when type 1 diabetes is initially diagnosed, many of the remaining functioning beta cells could survive and continue to secrete insulin. This would prolong the so-called “honeymoon period” shortly after the disease is diagnosed, during which it is relatively easy to maintain normal or near-normal glucose levels with a minimal amount of injected insulin.

This is just what anti-CD3 monoclonal antibodies aim to do. The therapy temporarily inactivates a type of immune cell called an “effector T-cell”, which is responsible for the destruction of pancreatic beta-cells. The therapy also increases the number of “regulatory

Artist’s illustration of an

anti-CD3 antibody binding

to a T-cell. The antibody

is x-shaped and shown in

green; the CD3-receptor is in

purple and gold.

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T-cells” that may control the number of attacking effector T-cells even after the anti-CD3 therapy is stopped. Through these two steps, there is hope that the progression of type 1 diabetes can be slowed and that the remaining damaged beta-cells will partially recover.

Results from the first trials of anti-CD3 therapy in people have been encouraging. In these studies, people treated with anti-CD3 therapy had significantly reduced insulin needs for four or more years compared to people who were given a placebo therapy. The benefits of anti-CD3 therapy were more apparent for people who began using the treatment immediately after their diagnosis, when fewer beta-cells had been destroyed. One study by Dr. Bart Keymeulen published in the New England Journal of Medicine in June of 2005 showed that in this early-treatment group, approximately 75% did not need insulin injections to maintain adequate glucose levels at 18 months after diagnosis. Although this may sound like a small window of freedom from a life-long disease, it can mean the difference between children developing diabetes in elementary school, when they are largely incapable of self-management, versus developing the disease when they become teenagers. Unfortunately, the treatment is rarely a cure, and almost everyone will require insulin injections after 2-4 years of therapy. However, one study by Dr. Sylvaine You in the journal Advancements in Immunology demonstrated that even four years out, the average insulin dose of people treated with anti-CD3 antibodies is about half that of matched controls.

The picture is not entirely rosy of course. For one, the convenience of an anti-CD3 intervention leaves something to be desired. The therapy is given as an intravenous (IV) infusion for several hours every day for several days, although there is hope that this will eventually be shortened. Reported side effects have been mild and short-lived and include flu-like symptoms. However the therapy is relatively new and has only been tested in a few hundred subjects. Therefore, there may be serious side effects or long-term risks in using anti-CD3 therapy that have not yet been teased out from the limited numbers of clinical trials.

Making Anti-CD3 a RealityTwo separate anti-CD3 drugs are in late-stage clinical trials in the US and Europe. One of these drugs is called otelixizumab and was developed by a biotech company called Tolerx, which is partnered with GlaxoSmithKline. The other anti-CD3 drug, teplizumab, was developed by the biotech company MacroGenics and its partner Eli Lilly. The development of both otelixizumab and teplizumab was aided by the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF).

Anti-CD3 drugs are unlikely to be approved in the US before 2012 because they have just begun a mandatory final round of clinical testing (called phase 3 testing). In the meantime, some people who are diagnosed with type 1 diabetes are choosing to enroll in clinical trials of anti-CD3 therapy even though the risks of the drugs are not entirely known.

One person who has participated in a clinical trial of an anti-CD3 drug is Marinda Maxwell, a mother of two who at the time of her diagnosis was 41 years old. This is indeed an unusual age to develop type 1 diabetes, although late-onset type 1 is becoming increasingly common and many doctors also believe that a number of people wrongly diagnosed with type 2 at this age actually have a form of type 1 known as LADA (latent autoimmune diabetes in adults). For Marinda, the decision to enroll in a clinical trial of anti-CD3 was motivated both by a sense of altruism and self-interest. “I wanted to help make advances in research”


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“Anti-CD3 is not my

ultimate goal for

diabetes. It makes

my diabetes more

manageable and that is

fabulous, but it is not a

cure.

-Marinda Maxwell,

an anti-CD3 trial

participant

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she told us in a recent interview. “At the same time, I knew that if I could maintain any beta-cell function, my diabetes would be easier to manage.”

Marinda enrolled in the clinical trial of the anti-CD3 drug otelixizumab ten months after beginning to take insulin injections. Her body began producing significantly more insulin after using the drug and the side effects of the therapy were minimal. “The Sudafed [they made me take] made me feel worse than the drug” she joked to her medical director. Although she is pleased with her experience, she emphasizes that anti-CD3 is not a magic bullet for type 1 diabetes. “Anti-CD3 is not my ultimate goal for diabetes. It makes my diabetes more manageable and that is fabulous, but it is not a cure. A life without diabetes at all - that is the ultimate goal.”

The slow enrollment of anti-CD3 trials has the potential to delay the approval of the first anti-CD3 drugs. These trials have been especially hard to fill because of their restrictive inclusion criteria: people over the age of 18 who have been diagnosed with type 1 diabetes less than 90 days before choosing to enroll. Marinda, who has been involved with the JDRF for over 11 years and was the JDRF International Volunteer of the Year in 2007, encourages others to follow her example and enroll in clinical trials for anti-CD3 drugs or other therapies for type 1 diabetes. “My hope is that people can realize the necessity for all clinical trials and search for one that might be applicable to them” she says. “It is the only way that we will get closer to the cure!”

Anti-CD3 Therapy TomorrowThe potential applications of anti-CD3 therapy do not end with newly diagnosed type 1 diabetes. In fact, the therapy could eventually be used to treat a whole host of autoimmune diseases that commonly afflict people with diabetes such as hypothyroidism and Graves Disease.

Anti-CD3 therapy may also be useful in the prevention of type 1 diabetes in people who have auto-antibodies (antibodies that attack one’s own cells) and are at high risk for getting type 1 diabetes in the future. As noted earlier, by the time type 1 diabetes is typically diagnosed, most of the patient’s beta-cells have already been destroyed. Some experts believe that anti-CD3 would be much more effective and might even prevent type 1 diabetes entirely if it were used earlier in the course of disease – before type 1 diabetes is usually diagnosed. A prevention trial using anti-CD3 therapy is expected to begin later this year in Europe.

Someday, anti-CD3 therapy may make a cure for established type 1 diabetes possible. One potential avenue to curing type 1 diabetes would be to transplant new beta-cells to make up for the ones that have been lost, a process known as islet transplantation. However, one of the hurdles facing islet transplantation is that the same process that destroyed the person’s own beta-cells could recur with the transplanted cells. This is where anti-CD3 drugs may come to play a role. The drugs could be used in place of general immunosuppressive drugs (used to protect transplanted cells) and in theory should have fewer side effects and be more effective as well. Of course, many hurdles remain in islet transplantation (most salient among them, the question of how to grow or extract enough cells to treat all people with type 1 diabetes). Additionally, anti-CD3 has not been tested for use with islet transplantation.

In the meantime, some people with type 1 diabetes say that the thing that excites them most about anti-CD3 therapy is the hope that it might help friends and family that are diagnosed

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Someday, anti-CD3

therapy may make a

cure for established

type 1 diabetes

possible.

“My hope is that

people can realize

the necessity for

all clinical trials and

search for one that

might be applicable

to them. It is the only

way that we will get

closer to the cure!

-Marinda Maxwell

www.diaTribe.us

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in the future. “I think it’s wonderful to see pieces of a possible cure for type 1 diabetes coming together,” says diaTribe editor Kelly Close. “And like many other patients who have had diabetes for decades, I’m also especially happy to know that today much better treatment alternatives exist at the time of diagnosis than I had – and certainly much, much better alternatives exist than all those who were diagnosed decades before me.”

Editors note: See Trial Watch in issue 12 for information on participating in a clinical trial of anti-CD3 therapy.

conference pearls The 2009 Advanced Technologies and Treatments T1/2

for Diabetes meeting (ATTD) The first major diabetes technology conference for this year was the Advanced Technologies and Treatments for Diabetes conference (or ATTD), held in Athens, Greece and bringing diabetes experts from all over the world. The biggest updates from this conference concerned continuous glucose monitoring (CGM) and progress towards a closed loop system using a pump connected to a CGM. We attended some presentations regarding a cure for type 1 diabetes, but this area of research continues to move very slowly.

Continuous Glucose MonitoringCGM systems continue to be a hot topic everywhere we go, and it seems like there’s more news for every issue! More and more researchers are studying CGM,

and they are definitely improving in terms of accuracy and ease of use. The accuracy improvements represent great news – the more evidence there is that CGM can help improve management, the more big insurance companies will continue to climb onboard and reimburse for CGM systems, making them more accessible to patients who can’t afford them on their own. Read this issue’s NewNowNext for a list of insurance companies who are reimbursing for CGM and how you can get more information. We know, of course, that there are still some major limitations because of all the people without insurance, with high deductibles, and in countries outside the US where CGM isn’t yet approved or reimbursed. We are glad the products are improving but sorry that insurance remains a barrier for some patients.

Diabetes technology expert Dr. John Mastrototaro, Vice President of Global, Medical, Scientific and Health Affairs at Medtronic, spoke at the conference and filled the audience in on some CGM improvements that the company has in the works. These include: 1) increasing the life of each sensor from three days to six days, 2) decreasing the startup time from two hours to 30 minutes, 3) reducing (or even eliminating) the need for traditional fingerstick calibration, 4) reducing sensor size and combining the sensor and insulin pumping site, and 5) improving the accuracy of the sensor. Of these improvements, we think that longer sensor life is closest to being ready, but Medtronic didn’t give any

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Dr. John

Mastrototaro, Vice

President of Global,

Medical, Scientific

and Health Affairs at

Medtronic, filled the

conference attendees

in on some CGM

improvements that

the company has in

the works.

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definite timelines - we imagine these are from near-term to long-term. We’ll be following this closely.

diaTribe Advisory Board member Dr. Lois Jovanovic of the Sansum Diabetes Research Institute (in Santa Barbara, CA), well-known as the world expert on pregnancy and diabetes, talked about her work using CGM systems during pregnancy. It’s well accepted that hypoglycemia and hyperglycemia during pregnancy increases the risk of birth defects, and it’s often very hard for pregnant women with diabetes to maintain the stellar glycemic control recommended by Dr. Jovanovic. But, one silver lining on glycemic control and pregnancy of late – Dr. Jovanovic has found that using CGM can dramatically help patients to detect hyperglycemia and hypoglycemia that they might not otherwise have noticed, allowing them to dramatically improve their glucose-management therapy (with their doctor’s help, of course) and protect their baby’s health. This applies to people who have type 1, type 2, and gestational diabetes (meaning diabetes that starts during pregnancy and then resolves).

Talk to your doctor about CGM if you fit into any of these categories and are pregnant or thinking about becoming pregnant. Planning is key - internal organs begin development in humans within the 3rd to 8th weeks in utero (this is called organogenesis) and so ideally, blood glucose control ought to be very good before pregnancy begins. Dr. Jovanovic recommends that patients work with their doctors and diabetes educators to get an A1c of “well below 6.0%” (she prefers around 5.0 – 5.5%) prior to pregnancy for those with established type 1 or type 2 diabetes. Although this is a major challenge for virtually anyone with diabetes, fertility, as she says, is a wonderful motivator – and CGM can be an incredibly helpful tool on this path.

The Artificial Pancreas—revisitedThis meeting was filled with compelling talks about the artificial pancreas—some projects are further along than others, but overall there is clearly meaningful forward progress. We were particularly impressed by two presentations, one by Dr. John Mastrototaro and the second by Dr. Eyal Dassau also of the Sansum Diabetes Research Institute. These talks were focused on efforts to refine the computer program (algorithm) that will be used to give automatic insulin dosing from an insulin pump based on glucose readings from a CGM. Dr. Mastrototaro gave a very interesting presentation about the work Medtronic is doing to close the loop. Medtronic has a working algorithm that has been tested in three different trials. Closed-loop (i.e. automatic glycemic control without human intervention) studies using this algorithm have shown good nighttime glucose control, which is really exciting – basically, this is easier than daytime control because there aren’t outside factors like food and stress that the system has to address. During the day, the system still has challenges coping with carbohydrates from meals. To help solve this problem, the company has added features that let you tell the system when you’re about to eat a meal and give manual meal boluses (this is called a hybrid closed-loop system). In a study done at Yale University by diaTribe Advisory Board member Dr. Bill Tamborlane and his team, a person who started at an A1c of 7.1% (certainly good control) was able to increase his ‘time in the zone’ from 58% to 82% using a trial closed-loop system. We want this! Exercise is, of course, another variable that can affect blood glucose near to the time of exercise as well as hours later. Researchers are still designing systems that can easily handle the effects of exercise.

Dr. Dassau presented an alternative idea for an algorithm that may be better able to control blood glucose automatically. Essentially, Dr. Dassau’s idea is to have a specific

This meeting was

filled with compelling

talks about the

artificial pancreas—

some projects are

further along than

others, but overall

there is clearly

meaningful forward

progress.

www.diaTribe.us


type of algorithm (called MPC, for model predictive control) that is in direct control of administering insulin, and then have that algorithm watched by a second algorithm called the ILC (iterative learning control) that would ‘learn’ the ups and downs and general patterns of a person’s blood sugar over the course of a day and fine-tune the performance of the MPC algorithm. Although it’s more complicated, this type of approach has performed exceptionally well in computer models. Even when researchers simulated variations in meals without giving any notice to the algorithm, the system was able to avoid (simulated) hypo- or hyperglycemia 96% of the time! This is only a simulation, but gives important insights for real patients. We think that this technology shows great promise for use in future closed-loop systems. However, the important question of patient safety is still an issue, and it seems that safety will be harder to prove with more complicated algorithms than with simpler ones.

Slow Progress Toward a CureCures for type 1 diabetes were not a primary focus at this meeting, but were addressed during several talks. We’d like to fill you in on a new approach that you may not have heard about. We note there isn’t really news here yet in terms of establishing successful treatment but for anyone who wants to read about what’s in early research on this front, read on ...

The new treatment idea is to make a diabetes ‘vaccine’. As you may be aware, type 1 diabetes is an auto-immune disease, which means that a person’s immune system inappropriately recognizes his insulin-producing beta cells as foreign and destroys the cells. Dr. Tihamer Orban, a researcher at the world-renowned Joslin Diabetes Center in Boston, has devised an injectable drug that is designed to desensitize a newly diagnosed patient’s immune system to insulin, stopping the attack on their beta cells. The drug doesn’t work like a typical vaccine (which introduces a foreign substance into your body), but more like the shots available to protect people from hay fever or pet allergies. He’s already completed a two-year phase 1 trial in newly diagnosed type 1 patients. Phase 1 trials are designed to show whether the treatment is safe – phase 2 trials should show the efficacy, or whether it works. We’ll be watching to see what happens next. To read more about Dr. Orban’s work, go to http://www.joslin.org/732_1832.asp.

Dr. Yong Zhao of the University of Illinois is working on the same problem but taking a very different tack. His research group has discovered that the T cells that are responsible for immune attack on the pancreas in diabetes, can be suppressed using stem cells from a person’s umbilical cord. For the tests he’s done in mice so far, he removes T cells from the animals and exposes them to the stem cells. The T cells are then reinjected into the mice. The exposure to stem cells seems to diminish the T cells’ response to insulin and is believed to reduce T cell attacks on the pancreas. His group has shown that this treatment can completely normalize the blood sugar levels of diabetic mice, and he thinks it would be safe and even low-cost when applied to humans. It’s impossible at this point to say where his team’s work might lead, but it’s likely that the diabetes community will start to see more stem-cell-based trials in the next few years with the progressive steps taken by President Obama thus far. In our view, it’s too early to say which, if any, of the various approaches will succeed or when such treatments are likely to become available. But, we wanted diaTribe readers to know what was happening in early research. Two promising companies that we know of are currently working on diabetes vaccines: Bayhill Therapeutics and Diamyd Medical.

12

It’s much too early to

tell whether diabetes

vaccines will be

successful--later

stage results will tell

us more.

www.diaTribe.us

NewNowNext Onglyza...the next Januvia? On April 1st, diaTribe traveled to Washington DC to observe the regulatory T2

discussions on a new diabetes drug awaiting approval in the US (and Europe). The new drug, called saxagliptin, is a new kind of DPP-4 inhibitor, the same class of drug as Januvia. At the meeting, the FDA brought a panel of physician and research experts (called the Advisory Committee) to discuss the safety and efficacy of the drug and give recommendations about whether or not it should be approved. After a full day of sometimes heated discussion, the panel voted overwhelmingly to recommend that the drug could be approved. The final decision is still in the hands of the FDA, but the agency almost always agrees with the panel in the end. That said, the FDA recently postponed its decision date by an additional three months, likely due to resource constraints at the FDA. Regardless, it seems likely that saxagliptin (which, if approved, will be called Onglyza) will soon be available for your doctor to prescribe—so far it appears to be a safe drug with moderate efficacy that is very similar to Januvia.

The FDA and Liraglutide On April 2nd, right after the saxagliptin meeting, the FDA Adivisroy Committee T2

discussed liraglutide, a once-daily injectable medication for type 2 diabetes that works in a way similar to Byetta--it’s a member of the GLP-1 class. We’ve been looking at this drug with anticipation for a long time now; its convenient dosing may offer advantages for patients, all else equal. However, this time the Advisory Committee was tied on the issue of whether or not liraglutide was approvable, based on concerns about a specific cancer in laboratory animals - while there is no increased risk of that cancer has been seen in people taking liraglutide, the committee voted that they couldn’t rule out the risk. Because of the tie, there is a delay for liraglutide — we aren’t sure yet what the FDA will do based on the Advisory Committee’s recommendation. Liraglutide recently received a positive opinion from regulatory authorities in Europe, and we would expect to see it on the market there in the next couple of months. We’ll look to see if this has any impact on the FDA’s decision.

Be inTouch with your diabetes management We’d like to tell you about a new diabetes management program from J&J’s T1/2

SymCare branch that has just received FDA approval this month. The program, called inTouch, is designed to help you and your doctor share information about your diabetes and help you maintain better control. It helps to promote education about diabetes, allows you to upload information from your glucose meter and get online coaching from nurses, and has a reward system that gives you Amazon gift cards when you meet diabetes management or educational goals. SymCare is designing trials using the inTouch program that will study whether it succeeds in improving diabetes management in the real world—we think the technology has promise, and we’re very curious to hear what they discover. In general, we think information technology has the potential to change diabetes care for the better, and inTouch seems like a first step in that direction. The inTouch program is currently being offered through employers, so ask your company about the new program. So far, inTouch only works with OneTouch meters, but the plan is to eventually open it up to other brands as well. If you sign up for the program and aren’t using a compatible meter, the SymCare team will give you a new meter free of charge. For more information, point your browser (and your boss) to http://www.symcare.com.

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www.diaTribe.us

CGM Reimbursement If you’re a regular diaTribe reader, you probably know that we’re big fans of T1/2

Continuous Glucose Monitoring (CGM)—devices that let you see your glucose levels in real-time and watch whether they’re going up, down, or remaining steady. We think that these devices can help people with type 1 and type 2 diabetes improve blood glucose control – even if it already appears to be really good!

However, truth be told, these are expensive devices and few people can afford to pay for them out-of-pocket. We thought it would be helpful to publish a list of insurance companies that have begun to offer favorable CGM coverage. Here’s the list, according to the Juvenile Diabetes Research Foundation (JDRF), strong proponents of CGM technology:

• Aetna—Will cover CGM for all patients with type 1 diabetes over age 25 or under 25 with severe hypoglycemia

• CIGNA—Will cover CGM for patients with type 1 diabetes with severe hypoglycemia AND for type 2 patients with recurrent severe hypoglycemia who meet a specific c-peptide threshold (talk to your doctor)

• Highmark Blue Cross Blue Shield and Humana—Will cover for type 1 patients with severe hypoglycemia or hypoglycemia unawareness (if you don’t notice when your blood sugar is severely low)

• Kaiser Permanente in CA—Will cover for all patients with type 1 diabetes who meet specific Kaiser coverage criteria

• United HealthCare—Will cover patients with type 1 diabetes who have not achieved optimum control (most people are probably eligible)

• Wellpoint/Anthem—Will cover patients with severe hypoglycemia or those who are pregnant

If your insurance company is on this list and you meet the criteria, you should ask your doctor about CGM, particularly if you have hypoglycemia unawareness or frequently unpredictable glucose levels. If your insurance company is not on the list, they should be, in our view, and the pressure is on, as all the big five “heavyweights” have approved CGM in some way.

Now, there’s one clear thing missing – most of this coverage is for type 1, even though we’ve heard from a number of type 2 patients that CGM may be helpful for them as well. The reason coverage is more limited for type 2 patients is because not enough studies have been done, and the benefits of CGM in type 2s are not as certain. We think there’s a clear message to companies – please do some more type 2 studies to find out if CGM can be beneficial!. In the meantime, a growing number of healthcare providers are offering CGM rentals for their type 2 patients. This makes great sense to us. If your A1c is over 7%, it might really help you to get into better control, and even if you don’t have a high A1c, it might help you avoid serious highs and lows. For type 2s who have never tried CGM, we might recommend a physician-based system first - we will be writing about this more in diaTribe #16. If CGM isn’t available, of course, you can get some of this information from a few days of taking 12-24 fingersticks every day, but CGM might be a better bet – ask them and ask them again!

By the way, the JDRF is a great resource to find out if your insurance company covers CGM, even if it’s not on the list above—go to http://www.jdrf.org/index.cfm?page_id=111281.

We really appreciate the work of the JDRF, which has done critical research to help persuade insurance companies to cover CGM devices. You can also visit the Children With

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www.diaTribe.us

Diabetes Insurance forum and join discussions or learn about what strategies have worked well for others at http://forums.childrenwithdiabetes.com/forumdisplay.php?f=57

Tour de Cure Red Rider program The Tour de Cure is a series of cycling races held by the ADA each year to fund T1/2

diabetes research. As we pointed out in Issue 13’s NewNowNext (http://www.diatribe.us/issues/13/new-now-next.php), there are many ways for everyone to participate in the Tour de Cure (racing, tandem biking, unicycling, you name it) but if you have diabetes, there’s another way to ride…in style. The Red Rider program gives every person with diabetes who signs up for the race a free signature bright red jersey or T-shirt. The idea is to visibly recognize the strength it takes to live with diabetes, and to foster a sense of community between riders. In addition to the jersey, people with diabetes can join Team Red, made up of other Red Riders and their supporters. To sign up, all you have to do is tell your local Tour coordinator that you’d like to be registered as a Red Rider when you sign up. If there’s no Team Red in your area you can start one as a captain or join the diaTribe team! We’ll be riding June 14 in Silicon Valley and Novo Nordisk CEO Lars Sorensen will be riding that day as well – if you would like to meet him, let us know at [email protected] as he promised to make time to meet the diaTribe riders! For more information about Red Riders, visit http://tour.diabetes.org/site/PageServer?pagename=TC_redrider.

No more Cozmo In case you haven’t heard, Smiths Medical recently decided to leave the insulin T1/2

pumping business and stop selling the Deltec Cozmo insulin pump. If you’re already a Cozmo customer, this probably won’t affect you immediately—Smiths has agreed to honor all existing warranties and provide customer service until the end of the warranty period. However, sooner or later you’ll need to change pumps. We’re sad to see the Deltec go, but there are plenty of other options available for pump users.

Medtronic has already started a new Medtronic Cares program to help make it easier for you to switch to a Medtronic pump. The program will give you a reduced price on a Paradigm REAL-Time pump with a two-year warranty, as well as 30 days of supplies. Animas and Insulet have just launched similar deals--Animas will lower the price of a OneTouch Ping to $900 and give you up to $700 for trading in your current pump, and Insulet has a special Omnipod starterkit for as little as $50.

To learn more from Smiths, go to www.delteccozmoupdate.com. To find out more about the Medtronic Cares program go to http://www.MedtronicDiabetes.com/cares, for more information about the Animas program go to www.animascorp.com/For-Deltec-customers.aspx, and for more on the Insulet program go to www.myomnipod.com/support/Cozmo/.

DiabetesMine Design Challenge Last month, diabetes advocate Amy Tenderich hosted her annual Diabetes Design T1/2

Challenge, giving you a chance to win funding to help you develop your ideas for new diabetes products or web applications. Entries took the form of either a 2-minute video or a 2-3 page document describing people’s ideas and showing a prototype with supporting graphics. The contest is now over, but you can view the contest details by going to http://www.diabetesmine.com/designcontest.

15


A group of Red Riders

sporting their jerseys

The Deltec Cozmo insulin

pump, which was recently

discontinued by Smiths

Medical.

www.diaTribe.us

logbook The Marathon Mom: A Long Journey of Love and T1/2

Sacrificeby James S. Hirsch

Some stories have a Hollywood ending, but those are so predictable. This story has two. It begins sometime last year, in a Boston suburb, when a group of parents with diabetic children meet to discuss with a magazine reporter the increase in kids diagnosed with the disease. One of the parents is Ray Allen, the Boston Celtic All-Star, and his wife, Shannon; their son Walker was diagnosed in June of last year.

Ray talks about his efforts to inspire others, just as he had inspired Shannon to run the Boston Marathon for a second time. Shannon says she had raised money for a different important cause in 2008, but next year, in 2009, she’d raise funds for the Joslin Diabetes Center in Boston, where Walker receives his care. In fact, she would be captain for a team of runners for Joslin. They’d run for the kids. They’d run for the clinic. They’d run for the cure. Who’s in? Hands start to rise.

Neither my wife nor I attend that meeting, but our 8-year-old son goes to Joslin, and we hear about the marathon challenge. Sheryl had run the Boston Marathon in 1997 and had wanted to do it again. Now she has the reason. With more than a dozen other parents and friends of Joslin, she’ll join the Joslin team. Everyone is supposed to raise $5,000. One small step for the Joslin, one giant leap for the cure.

The training will begin in the dead of winter, five long months before the April 20 race.

* * *

I have a theory that if they ever find a cure for diabetes, it will be the parents of diabetic children who find it. I don’t mean that the parents will be in the labs, doing the science. But they will be the ones raising the money, making the phone calls, writing the letters, urging the politicians, and holding the scientists accountable.

I’ve spoken to quite a few parents over the years and recognize their singular contributions. There was, for example, the mother in the 1960’s who, fearful that her son would have a bad low, would drive to his school and park on the street during his recess. She would just watch him, each day, to make sure he was okay. Before home glucose monitors, urine tests were used to determine approximate blood sugar levels. So what to do with a diabetic baby? Mothers would squeeze the baby’s wet diaper to get the drops.

Parents with a very young diabetic child are understandably reluctant to leave the child with a babysitter. One couple wouldn’t hire a babysitter for five years, so when they wanted to see a movie, the father went alone on Friday night, the mother went alone on Saturday night, and they talked about it on Sunday.

Sometimes parents must go to extraordinary lengths to treat lows. One mother who couldn’t get her hypoglycemic 5-year-old daughter to eat or drink had to speed to a corner store, in the snow at night, so the girl could choose something to consume. She chose chocolate milk but still balked at drinking, so the mom asked if she wanted to go to an empty parking lot and spin “broadies” on the snow and ice. The girl agreed but would only

16


I have a theory that if

they ever find a cure

for diabetes, it will be

the parents of diabetic

children who find it.

www.diaTribe.us

drink if her mother spun the car, so the night wore on, with the car skidding crazily across the slick asphalt. Spin, drink. Spin, drink.

* * *

These thoughts cross my mind as I watch Sheryl do her training. Like most of the Joslin runners, she is no longer in her 20’s or, truth be told, her 30’s. She normally runs on the weekends, but for several months, she wakes up at 5 a.m. three times a week, bundles up, and runs before going to work. Then she does a longer run – 10, 12, 14, 21 miles – on the weekend. Her stamina builds.

But she suffers nagging injuries – a problem with her hip, shin splints, blisters. She worries that the hip will force her to stop. She goes to different doctors and trainers, accumulating medical bills, looking for answers. But there are no answers, except to say she isn’t 40 any more and she isn’t even 45. She meets with one running specialist who works on her form and gives her some advice on tackling the steep climbs. “Don’t look at the top of the hill,” he tells her. Too daunting. The despair alone will stop you. “Keep your head down,” he stresses, “and take one step at a time.”

To read the rest of Sheryl’s inspiring run through Boston, go to www.diatribe.us/issues/15/logbook.php...

thinking like a pancreas Are You Using G.I. Joe? T1/2

by Gary Scheiner

In last issue’s Learning Curve, we explained the glycemic index (GI), and talked a little bit about how it can help you improve your diabetes management. For this month’s Thinking Like a Pancreas, we asked our resident management expert Gary Scheiner to tell us his thoughts on the GI based on his many years of experience with diabetes management.

Remember the song “War,” sung emphatically by the band “War”: War… what is it good for? Well, many people hold similar esteem for the

concept of glycemic index. What good is it really? After all, some say the glycemic index is imprecise, inconsistent and limited in practicality. Or is it?

Glycemic Index (GI) refers to the rate at which carbohydrates convert into blood glucose. Pure glucose is given a GI score of 100; everything else is compared to the digestion/absorption rate of glucose. The tables on the left show the GIs of a few common foods.

For a more comprehensive list of glycemic index values, take a look at the online version of this article or pick up a copy of:

The Ultimate Guide to Accurate Carb Counting • by Gary Scheiner, 2007 (www.amazon.com/Ultimate-Guide-Accurate-Carb-Counting/dp/1569242747)

or

New Glucose Revolution Low GI Guide to Diabetes• by Jennie Brand-Miller, J, 2006 (www.amazon.com/Glucose-Revolution-Guide-Diabetes-Authoritative/dp/1569243352)

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Food GI

Peanuts 15

Kidney Beans 23

Apples 38

Chocolate Cake 38

Food GI

Bagels 72

Corn Flakes 83

Baked Potatoes 85

Instant Rice 87

Low GI Foods

High GI Foods

Sheryl, James’s marathoner

wife, and their son Garrett

www.diaTribe.us

What the numbers represent is the percentage of carbohydrate that turns into blood glucose in the first two hours. Foods with a high GI (greater than 70) tend to digest and convert to blood glucose the fastest, with a significant blood glucose “peak” in 30-45 minutes. Foods with a moderate GI (45-70) digest a bit more slowly, resulting in a less pronounced blood glucose peak approximately one to one and a half hours after they are consumed. Foods with a low GI (below 45) tend to make a gradual appearance in the bloodstream. The blood glucose peak is usually quite modest, and may take several hours to occur.

Most starchy foods have a relatively high GI; they digest easily and convert into blood glucose quickly. Exceptions include starches found in pasta and legumes. Foods that have dextrose in them (i.e. cake mixes, cookies, crackers, custards) tend to have a very high GI. Fructose (fruit sugar) and lactose (milk sugar) are slower to convert into blood glucose. Table sugar (sucrose) has a moderate GI because it contains a combination of glucose (which is very fast) and fructose (which is slower). Foods that contain fiber or large amounts of fat tend to have lower GIs than foods that do not.

What Is It Good For?Why is glycemic index important? Because the effect of dietary carbohydrates is what really matters. In general, lower GI foods tend to make blood sugars easier to control. They enhance satiety and help to curb appetite. They serve as excellent fuel sources in preparation for endurance exercises, and they can also be used after very intense workouts to prevent delayed blood sugar drops.

High-GI foods tend to work best for treating hypoglycemia. Nobody wants to wait a long time for their blood sugar to come up when it is low, so consuming a food that converts into blood glucose quickly makes a world of sense. It is best to consume high-GI foods immediately prior to short bouts of exercise in order to prevent hypoglycemia. During illness, high-GI foods are ideal because they digest very easily, requiring the stomach to do as little work as possible. For those with gastroparesis (a nerve condition causing very slow digestion), high-GI foods are recommended to prevent nausea and post-meal hypoglycemia.

For those who take insulin, knowing the glycemic index of a food helps in determining the optimal time to take mealtime insulin. Foods with a high GI (greater than 70) tend to raise blood sugar the fastest. For these types of foods, it is best to take mealtime rapid-acting insulin 15-20 minutes prior to eating. This will allow the insulin peak to coincide as closely as possible with the blood sugar peak. Taking insulin for high-GI foods just before or while eating would produce a significant after-meal blood sugar “spike”, as the insulin action would lag behind the blood sugar rise by about half an hour.

Foods with a moderate GI (approximately 45-70) as well as most “mixed” meals digest a bit slower, with a slightly less pronounced blood sugar peak approximately 60-90 minutes after eating. Taking rapid-acting insulin 15-20 minutes before eating these types of foods could produce a low blood sugar soon after eating. It is best to take mealtime insulin immediately prior to consuming foods with a moderate GI. With low-GI (below 45) foods, the blood sugar “peak” is usually quite modest, and may take several hours to appear. Taking insulin prior to eating foods such as pasta or yogurt is likely to lead to hypoglycemia about one hour later, followed by a delayed blood sugar rise. Instead, try taking the insulin 10-15 minutes after eating. A second option is to split the rapid-acting insulin into two parts: half given with the meal, the other half about an hour later. A third option is to take Regular insulin with the meal, rather than a rapid-acting

18


In general, lower GI

foods tend to make

blood sugars easier to

control. They enhance

satiety and help to

curb appetite.

www.diaTribe.us

analog. One other option, available to insulin pump users, is to extend the bolus delivery over 60-90 minutes.

A Matter of AccuracyHow accurate is the glycemic index? Given the degree of inter-individual variability in digestion and the impact of mixing foods with different glycemic index values in the same meal, there is no way to tell exactly when a specific food or meal will cause the blood glucose level to peak. What glycemic index is good for is categorizing foods according to their relative impact: fast, moderate, and slow.

When looking at complete meals, the main source of carbohydrate should dictate the rate of blood glucose rise. For example, a meal where pasta is the primary carbohydrate should be treated as low-GI. A meal where potato is the major source of carbohydrates should be treated as high-GI. And don’t forget to take the fat content and size of the meal into account. Higher-fat meals will produce a slower blood glucose rise regardless of the nature of the carbohydrate, and larger meals usually take longer to digest than smaller meals.

So while it is true that subtle differences between GI values mean very little, major differences can certainly be used to your advantage. And we can use all the advantages we can get!

Editor’s note: Gary Scheiner MS, CDE is Owner and Clinical Director of Integrated Diabetes Services, a private consulting practice located near Philadelphia, for people with diabetes who utilize intensive insulin therapy. He is the author of several books, including Think Like A Pancreas: A Practical Guide to Managing Diabetes With Insulin. He and his team of Certified Diabetes Educators work with people throughout the world via phone and the internet. Gary has had type 1 diabetes for 24 years and can be reached at [email protected], or toll-free at 877-735-3648.

trial watch Advanced Medical Therapy versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes T2

ClinicalTrials.gov Identifier: NCT00432809http://www.clinicaltrials.gov/ct2/show/NCT00432809

Bariatric surgery is gaining popularity in the treatment of both obesity and type 2 diabetes. This surgery treats obesity by either restricting the amount of food a person can eat, by reducing the ability of the intestine to absorb nutrients, or both. Interestingly, however, some types of bariatric surgery are more effective at treating type 2 diabetes than doctors would guess based on weight loss alone. In this study, two types of bariatric surgery are being compared, laparoscopic Roux-en-Y Gastric Bypass (RYGBP) and laparoscopic sleeve gastrectomy. Both of these types of surgery have been shown to cause weight loss, but to date there has been no in-depth scientific study to determine which is more effective at resolving type 2 diabetes. To be considered for this study, patients must have type 2 diabetes with an A1c of more than 7.5% and a BMI of greater than 27 and less than 43 kg/m2. For information about enrolling in the trial, contact Chytaine Hall at [email protected] or by phone at 216-445-3983. A good place to learn more about bariatric surgery is at http://www.mayoclinic.com/health/gastric-bypass/hq01465.

19


While it is true that

subtle differences

between GI values

mean very little,

major differences can

certainly be used to

your advantage.

www.diaTribe.us

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes PatientsT2

ClinicalTrials.gov Identifier: NCT00680745http://www.clinicaltrials.gov/ct2/show/NCT00680745

This study investigates the efficacy and safety of dapagliflozin, a new type of medication for type 2 diabetes. Dapagliflozin is an inhibitor of an enzyme called SGLT-2, which is responsible for removing glucose from the urine and putting it back into the bloodstream. By blocking SGLT-2, dapagliflozin increases glucose excretion in the urine and lowers blood glucose levels. The study is testing dapagliflozin in addition to the sulfonylurea glimepiride (commonly known as Amaryl or Diapride) compared to glimepiride alone.

To be included in the study, you must be older than 18 years of age, have type 2 diabetes with an A1c between 7.0%-10.0%, and currently taking a sulfonylurea like Amaryl or Diapride. You are not eligible if you have type 1 diabetes, liver disease, or kidney failure or dysfunction. This study will be analyzing changes in A1c, body weight, blood glucose levels, and will monitor the side effects of dapagliflozin. The study lasts for 48 weeks. For more information, contact [email protected]. As we understand it, even though this study isn’t for people with type 1, this class of medicine is being tested in type 1 patients in other studies.

A Study of Taspoglutide versus Exenatide for the Treatment of Patients with Type 2 Diabetes Mellitus Inadequately Controlled with T2

Metformin, Thiazolidinedione or a Combination of BothClinicalTrials.gov Identifier: NCT00717457http://www.clinicaltrials.gov/ct2/show/NCT00717457

We think that one of the most promising drug classes available to treat type 2 diabetes is the glucagon-like peptide (GLP-1) analogs. GLP-1 is a hormone produced in the intestines that helps to regulate insulin secretion and glucose metabolism, and it helps to lower blood sugar levels while also producing weight loss. This study compares the safety and efficacy of a new GLP-1 analog, taspoglutide, to exenatide (Byetta).

To be eligible for this study you must be between 18 to 75 years of age and have type 2 diabetes with an A1c between 7.0%-10.0%. You must have been on metformin and/or pioglitazone (Actos) or rosiglitazone (Avandia) for at least 12 weeks. Lastly, you must have a BMI between 25 kg/m2 and 45 kg/m2 (or between 23 and 45 kg/m2 if you’re Asian) and have maintained a stable weight for at least 12 weeks prior to screening. If you enroll, you will be randomized to receive taspoglutide once per week or exenatide twice daily. Both medications need to be injected. During the study, researchers will measure changes in your A1c, body weight, natural insulin production, and a subset of patients will also be monitored for changes in glucose, insulin, c-peptide, and glucagon levels during a meal tolerance test. For more information, please call 1-800-526-6367.


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