in this issue from the editor e - diatribe · – dean kamen (president, deka research &...

from the editor

Earlier this month, the ADA released new estimates that places the cost of diabetes at a whopping $245 billion in 2012 – almost double the cost ten years ago in 2002. What’s driving this increase?

To start, 61% of that $245 billion is from hospital stays and prescription treatments of diabetes complications. Add the fact that millions more live with diabetes, and a startling picture emerges: while the per-person cost is troublingly high, much of the price results from poor blood glucose levels control. If we want to reduce that $245 billion, our public policy should focus

on preventing diabetes and on helping those with it stay as healthy as possible.

Though conversations on the growing prevalence of diabetes and obesity are beginning, they haven’t caused meaningful nationwide changes. Certainly, organizations like the Partnership for a Healthier America (PHA) promote wellness, and their work is terrific – Walmart revamping its supply chain with healthier foods and Disney removing sugary snacks commercials. However, PHA’s focus is corporate partnerships to end childhood obesity, and they can only go so far without substantive government policy changes and active involvement from all Americans.

I know such actions can be controversial – just look at the strong, polarized reactions to New York City’s recently overturned soda ban. I commend PHA and its corporate partners for their efforts, but our food policies present a strong headwind to meaningful change. The scope of the challenge is explored in Jim Hirsch’s Logbook on the best-seller Salt Sugar Fat.

Here is one idea: If we want to make a long-term difference in what people eat, we need to end federal corn subsidies – and, if I had my way, start subsidies for fruits and vegetables – but that’s an intensely political issue… or, at least, it would be if anyone ever discussed it.

Or think about physical activity: only 4% of elementary schools offer daily PE. PHA and Reebok will bring their BOKS PE programs to 1,000 schools by 2015. Amazing, but 60,000 elementary schools remain. It’s unreasonable to expect corporate partnerships to solve this problem – we need policymakers to get involved, and we as voters can ensure that happens.

We are living in a magic time, as we have the knowledge, medicine, and technology to bring the diabetes and obesity epidemics under control. Let’s start by taking responsibility for our nation’s children’s health – as First Lady Michelle Obama said at PHA’s Summit: “Now, we know that as parents, it’s not always easy to get our kids to eat what we serve them, but that doesn’t mean we ignore our responsibilities. I mean, we would never dream of letting our kids skip going to the doctor or learning how to add and subtract just because they don’t like it. And the same thing is true about eating healthy.”

That’s a compelling message about taking responsibility, but we as a society also need to make more ambitious changes. Fifty years ago, our nation’s willingness to set lofty goals built the Peace Corps and put astronauts on the Moon. Now, in 2013, it’s time to put that can-do focus toward solving one of the most pressing economic and public health issues we have ever faced.

Very best,

Kelly L. Close

I S S U E # 5 3 • A p r i l 2 01 3

from the editor ....................1Kelly on the alarming new data just released on diabetes costs and what we can do about it.

quotable quotes ..................2(S)he said what?!?

fingersticks ..........................2Top 3 reasons for our British mania…

new now next .....................3The FDA approved a new type of drug for type 2 dia-betes, what a controversial study on pancreatitis means for patients with type 2 dia-betes, exciting updates from Dexcom, and more.

Logbook ...............................7James Hirsch assesses the im-plications for diabetes from the bestseller Salt Sugar Fat.

adam’s corner ....................10Adam discovers why sleep is critical to diabetes control.

conference pearls ..............13The artificial pancreas in patients’ homes at the Annual Technologies & Treatments for Diabetes Meeting in Paris.

conference pearls ..............15Michelle Obama at the Partnership for a Healthier America.

trial watch .........................18Is a GLP-1 agonist better than an ultra-rapid insulin analog? How can we prevent hypoglycemia while driving?

in this issue

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

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D I AT R I B E # 5 3 • 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 EditorsAdam BrownMargaret Nguyen

Senior Advisor James S. Hirsch ContributorsMelissa AnHannah DemingJessica DongAmro El-AdleKira MakerNina RanGary ScheinerJoseph ShiversKerri SparlingEllen Ullman

diaTribeadvisory boardDr. Richard Bergenstal, MD Jennifer Block, RN, CDEDr. Zachary Bloomgarden, MDDr. Bruce Bode, MDDr. Nancy Bohannon, MDDr. Bruce Buckingham, MDDr. John Buse, MD, PhDDr. Wendell Cheatham, MDDr. Edward Damiano, PhDDr. Michael Dougan, PhD Dr. Steven Edelman, MD Dr. Satish Garg, MD Dr. Barry Ginsberg, MD, PhDJeff HalpernDr. Karin Hehenberger, MD, PhDDr. Lutz Heinemann, PhD Debbie Hinnen, CDEDr. Irl Hirsch, MDJeff HitchcockDr. Phillip Home, D. Phil, DMDr. Lois Jovanovic, MDDr. David Kendall, MDDr. Samuel Klein, MDDr. Aaron Kowalski, PhDDavida Kruger, BC-ADMDr. Harold Lebovitz, MD, PhDDr. William H. Polonsky, PhDMichael RobintonDr. Francesco Rubino, MDDr. Steven Russell, MD, PhDGary Scheiner, MS, CDEDr. Jane Jeffrie Seley, DNP, CDEDr. Jay Skyler, MD Dr. William Tamborlane, MDVirginia Valentine, CDEDr. Kenneth Ward, MDHope Warshaw, RD, CDEDr. Stuart Weinzimer, MDDr. Darrell Wilson, MDDr. Howard Wolpert, MDDr. Mark Yarchoan, MDGloria Yee, RN, CDEDr. Paul Zimmet, MD, PhD Dr. Bernard Zinman, MD Dr. Howard C. Zisser, MD

quotable quotes“I think there has to be a perception shift. Right now, the human body is thought of as a harbinger of disease. It’s not that. It’s imperative is to be healthy…If there was one lever to pull, we have to change the dynamic of excess intake of nutrient poor, highly concentrated sugar…How have we al-lowed our food system to be so altered?”

– Gail Christopher (VP, Kellogg Foundation, Battle Creek, MI) during the Building a Healthier America Summit in Washington, D.C., March 7-8, 2013.

“If airlines were run and regulated the way healthcare is, they would put a plane out there and not refill the tank, because they would not get reim-bursed for doing so. The airline would [only] get reimbursed once the plane crashes.”

– Dean Kamen (President, DEKA Research & Development Corporation, Manchester, NH) during the Building a Healthier America Summit in Washington, D.C., March 7-8, 2013.

“In all my years of clinical practice, severe hypoglycemia is more detrimental and more negative than anything – it doesn’t allow you to intensify manage-ment. Patients are not willing to listen to you and won’t come back into the clinic. I don’t understand why FDA does not realize that reducing severe hypoglycemia is far more important than a small rise in A1c.”

– Dr. Satish Garg (Barbara Davis Center, Denver, CO) discussing the tradeoff between devices that reduce hypoglycemia but have the potential to slightly increase A1c at the 6th International Conference on Advanced Technologies and Treatments for Diabetes, Paris, France, February 27-March 2, 2013.

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new now next

FDA Approves Invokana, a New Therapy for Type 2 Diabetes

The Food and Drug Administration (FDA) on March 29, 2013 announced its approval of Janssen Pharmaceuticals’ Invokana (canagliflozin), a new SGLT-2

inhibitor for type 2 diabetes. Janssen Pharmaceuticals is a part of Johnson and Johnson.This is the first approval in the US of an SGLT-2 inhibitor.

We think the approval is great news for two reasons: 1) This drug has a unique mecha-nism that other drugs lack, giving health care providers (HCPs) another option for pa-tients; and 2) this suggests the FDA is more open to approving more drugs – we were very worried since the agency did not recently approve Novo Nordisk’s insulin degludec.

To understand Invokana’s long-term effects better, the FDA required five long-term studies for the drug including a cardiovascular outcomes study (CANVAS), a bone safety study, two pediatric studies, and a pharmacovigilance program that will monitor side ef-fects. That’s a lot to require, but Janssen has the resources and is well on its way through CANVAS, its cardiovascular outcomes trial, that began in 2009 and will finish in 2018.

Though there is a lot of talk about too much spending on new drugs and technology, that is a misnomer. The average per-patient spending has not actually increased since Dia-betes Care, the main journal of the American Diabetes Association, began tracking the costs of diabetes in the late 1980s. What has gone up is overall spending since the num-ber of patients with diabetes has grown so much in the last decade in particular – it has increased from 6.5 million diagnosed US patients in 1987 to over 22 million in 2012. You can help slow down the increased spending by working with your HCPs to make sure that your care is “personalized” to what you need. Take a look at our patient guide (diaTribe.org/patientguide) and determine with your healthcare team how your care can improve.

To learn more about Invokana and this new kind of medication, see diaTribe #51 from January 2013, which focuses on SGLT-2 inhibitors. The issue features a learning curve about SGLT-2 inhibitor medications. It also includes our interview with Dr. Sanjay Kaul, noted cardiologist from Cedars-Sinai Medical Center, Los Angeles, and his thoughts on Invokana and the FDA Advisory Committee on Invokana. diaTribe also attended and covered the exciting meeting at the FDA, including a talk we gave urging for more alterna-tives for patients.

The FDA aproval is also good news for people with type 1 diabetes - it is thought that they may be able to benefit from this therapy, and there is work from various companies to see if this might help type 1 patients.–KC/NR/JD

The American Association of Clinical Endocrinologists and the Ameri-can Diabetes Association Respond to a Study Finding that GLP-1-Based Therapies Increase the Risk of Pancreatitis

A study in the Journal of the American Medical Association (JAMA) found that patients with type 2 diabetes who had been taking the GLP-1 agonists Bydureon (exenatide once-weekly) or Byetta (exenatide) or the DPP-4 inhibitor Januvia (sitagliptin) within the last two years had higher odds of hospitalization for pancreatitis than those who never used these drugs. In response to the study, the American Association of Clinical Endocrinolo-gists (AACE) and the American Diabetes Association (ADA) released a joint statement,

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Invokana is a new type of drug that causes the kidneys to eliminate excess sugar to decrease blood sugar.

www.diaTribe.org

This is the first approval

in the US of an SGLT-2

inhibitor.

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which argued that the study “does not provide the basis for changing treatment in people with diabetes,” and that we need to wait for results from “prospective randomized con-trolled clinical trials (RCT), the gold standard for evaluating treatments.” Prospective RCTs are designed to investigate cause and effect – they are designed up front to measure the impact on an “outcome” (like pancreatitis) from an “intervention” (in this case GLP-1 agonists or DPP-4 inhibitors), instead of analyzing data from different trials afterwards. This makes their results less likely to be confused by other risk factors, called confound-ing factors. The AACE and ADA rarely comment on clinical studies, and this suggests they are concerned the results could be misconstrued and cause people to stop their medica-tions.

In the JAMA study, researchers analyzed data from administrative insurance claims from seven Blue Cross Blue Shield Association Plans. They compared 1260 people with type 2 diabetes who had pancreatitis and took the drugs with 1260 others who did not (the control group). People from each group were matched based on age, sex, and diabetes severity. Their statistical model compared these groups and took into account possible confounding factors, which include previously taking metformin, high triglycerides, alco-hol use, tobacco abuse, obesity, and pancreatic cancer among others.

Since the study is based on administrative claims data, it has limitations. For example, the researchers could not know when patient information was not coded correctly: in-formation about patients’ tobacco or alcohol abuse or if they have obesity are not always reported. Dr. Philip Home (DM, PhD, Newcastle University, Newcastle upon Tyne, UK) noted an issue with the data: “Unfortunately the authors document that there are marked differences in the characteristics and findings between the treated and control groups. This represents a fundamental flaw in the study and means that any comparison is invalid and should not have been made.” This study is aimed at identifying safety risks, and along with knowing the study’s results, it’s important to understand its limitations.

Past studies of GLP-1 agonists (Bydureon, Byetta, and Victoza) and DPP-4 inhibitors (Januvia, Onglyza, Tradjenta, Nesina) – and their association with pancreatitis – give conflicting results about their safety, and this JAMA study adds to that list. However, most clinical studies do not suggest a link between the drugs and pancreatitis. When we spoke with Dr. Daniel Drucker (Samuel Lunefield Research Institute, Ontario, Canada), he said there is not currently a biological mechanism for how these drugs could cause pancreatitis. He is waiting for RCTs before making his own decision, and characterized administrative-database focused research as “weak and misleading”. Currently, AACE and the ADA are waiting on the results of ongoing RCTs with over 65,000 participants to get more information on whether the drugs increase the risk of pancreatitis. The FDA is also investigating this question and has opened its own safety review. In the mean-time, the AACE, ADA, and FDA recommend that people who are concerned about these drugs discuss the topic with their healthcare providers and not change their medications on their own. For background on GLP-1 agonists and DPP-4 inhibitors, see the learning curve from diaTribe #8). –MN/NR

Dexcom Announces Progress on a Pediatric Label for the G4 Platinum CGM and Development of New Remote Monitoring Product, Dexcom Share

In February, Dexcom submitted an application to expand the label for the G4 Platinum CGM (continuous glucose monitor) to pediatric patients who are as young as two years old. The FDA normally responds to these applications after 180 days, and we expect a de-cision from the agency during the second half of 2013. Currently, the G4 is only approved for those who are 18 years and older. Though some children are now using the CGM, they

T1

The AACE and ADA

released a joint

statement, which

argued that the study

“does not provide the

basis for changing

treatment in people

with diabetes.”

www.diaTribe.org

Currently, AACE and

the ADA are waiting on

the results of ongoing

trials with over 65,000

participants to get more

information on whether

the drugs increase the

risk of pancreatitis.

www.diaTribe.us


5

are using it “off-label,” and not all healthcare providers (HCPs) are comfortable prescrib-ing therapies in this way. CGM can be a tremendous help for improving glycemic control and avoiding hypoglycemia (see conference pearls from diaTribe #51), and most HCPs and researchers believe the G4 Platinum is currently the most accurate CGM on the US market. This approval would give greater access to children who currently have difficulty getting a prescription for the G4.

Dexcom is also working on a new remote monitoring product, Dexcom Share. The prod-uct is a cradle that holds the G4 Platinum receiver and plugs into a power outlet at a user’s bedside. Data from the G4 Platinum are then sent via the cradle (using Bluetooth) to a nearby smartphone. That phone then uploads the data to a web-based platform, where it can be monitored by parents/caregivers on their own cellphones. At the ATTD confer-ence, Dexcom showed a picture of a father on a business trip in a taxi, checking his phone with a sigh of relief that his daughter’s CGM reading was 150 mg/dl. Dexcom’s goal is to submit Dexcom Share to the FDA in the second half of 2013, meaning it could be on the market in 2014. Dexcom Share is similar in concept to Medtronic’s FDA-approved remote monitor mySentry – the key difference is that Share will send CGM readings to smart-phones and the web, while mySentry sends pump and CGM readings to a bedside monitor within 50-100 feet. –MN/AB

The American Diabetes Association estimates the economic burden of diabetes in 2012 to be $245 billion

Earlier this month, the American Diabetes Association (ADA) and the co-chairs of the Senate Diabetes Caucus, Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), announced the results of a study of the economic burden of diagnosed diabetes in Diabetes Care (2013). The ADA estimates that the cost of diabetes was $245 billion in 2012, including $176 billion in direct medical costs and $69 billion in reduced productiv-ity. The cost of diabetes is up 41% from 2007 and up 86% from 2002, and by our infla-tion adjusted calculations, up 21% from 2007 and up 46% from 2002 – still a substantial increase; these calculations only include people who are diagnosed with diabetes. Overall, more than one in five dollars spent on healthcare (23%) in 2012 was directed to care for people with diagnosed diabetes. The largest healthcare costs were related to hospitaliza-tion and diabetes complications: 43% for inpatient hospital stays and 18% for prescrip-tions to treat complications.

According to the ADA, the main reason for the cost increase is that there are now more people living with diabetes (the cost for treating each person has not increased): approxi-mately 22 million people had diagnosed diabetes in 2012, up a striking 27% from 2007. Additionally, more than seven million Americans are estimated to have undiagnosed diabetes, meaning a total of 29 million people have it (diagnosed and undiagnosed) in the US – for perspective, in 1986, there were 30 million people globally who had diabetes.

In the past five years, the percentage of costs due to medications for diabetes and diabe-tes supplies has remained stable (12% in 2012, 12% in 2007, and 13% in 2002). That only 12% was spent on medications and supplies also suggests that an effective way to reduce spending on diabetes is to target other areas driving these rising costs. Since the biggest bucket comes from hospital care, we hope to see more therapies and technologies aimed at preventing type 2 diabetes and at keeping people healthier and out of the hospital. –MN/HD

T1/2

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The ADA estimates that

the cost of diabetes

was $245 billion in

2012, including $176

billion in direct medical

costs and $69 billion in

reduced productivity.

www.diaTribe.org

The Dexcom G4 Platinum with its 20 feet range between the transmitter and receiver helps parents monitor their children’s blood glucose levels from a separate room.

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Novo Nordisk launches Tresiba (insulin degludec) in United Kingdom and Denmark

In March 2013, Novo Nordisk launched Tresiba (insulin degludec), its new once-daily basal insulin for type 1 and type 2 diabetes, in the UK and Denmark. Tresiba will be priced roughly 70% higher than the other leading basal insulins, Lantus (insulin glargine) and Levemir (insulin detemir), in the UK and about 49% higher than Lantus in Denmark. However, because the UK’s National Health Service has been able to negotiate the price of Lantus and Levemir down, Tresiba will still be only $3.63 per day there ($109 per month; for someone taking 50 units/day).

In phase 3 trials, Tresiba demonstrated a similar A1c reduction versus Lantus (insulin glargine), but with a 26% lower risk of nocturnal hypoglycemia. The insulin will come in two devices – a pre-filled FlexTouch pen or the refillable Penfill – and in two concen-trations (U-100 and U-200), allowing users to take a maximum of 80 or 160 units in a single injection. The latter dose is the highest possible in an injection on the market, and is useful for people with significant insulin resistance and high insulin needs who cur-rently must split their basal insulin injections. Another advantage of Tresiba is an option for more flexible daily dosing than is possible with current basal insulins. While Novo Nordisk is officially recommending that Tresiba be taken at the same time each day to get the best results from the drug, patients have the possibility of delaying or taking the injec-tion earlier as needed (as long as there is a minimum of eight hours and a maximum of 40 hours between the injections). For instance, if your last Tresiba dose was on Monday at 9 am, your Tuesday dose could be taken at 5 pm, and your Wednesday dose could be taken at 9 am again.

The FDA recently sent Novo Nordisk a Complete Response Letter (CRL) for Tresiba and Ryzodeg (Ryzodeg is a mixture of 70% Tresiba and 30% Novolog), asking for a pre-ap-proval cardiovascular outcomes trial (CVOT) to show if the insulin has an unacceptable safety risk for heart disease. See our Editor-in-Chief Kelly Close’s letter from diaTribe #52 to learn how the FDA’s response may affect future drug development. It will take some time to design the CVOT and find enough participants to enroll in the trial, but we will report back with further developments in Tresiba’s path toward approval. –MN/JD

Vivus Launches a Discount Save Now! Program for Qsymia

On March 1, Vivus started its Save Now! program, which sets a discounted price of $75 for one 30-day supply of the company’s weight management medication

Qsymia at the recommended dose (7.5 mg phentermine/46 topiramate per day). This program is in addition to their Get Started! program, which is a free 14-day trial of its starting dose (3.75 mg phentermine/23 mg topiramate per day), and those who are in the Get Started! Program can transition into the Save Now! Program. This should help both new and existing patients who want to use Qsymia.

As of the last update, only 25% of Qsymia prescriptions were covered by an insurer (this is increasing, but it’s still not where it could be, since the medication is so new). The program should also help those who are interested in trying the medication but have not done so because of cost concerns.

People who are eligible for Save Now! include those who live in the US and who are 18 years or older. Unfortunately, people who are in state or federally funded healthcare pro-grams – Medicaid, Medicare, Tricare, Veterans Affairs, Department of Defense, or Indian Health Services – do not qualify for the discount.

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An advantage with

Tresiba is an option

for more flexible daily

dosing. If your last dose

was on Monday at 9

am, your Tuesday dose

could be taken at 5 pm,

and your Wednesday

dose could be taken at

9 am again.

www.diaTribe.org

Tresiba is available at two doses, U-100 and U-200, and in two types of pens, the FlexTouch pen or the refillable Penfill.

Qsymia’s Get Started! and Save Now! programs give patients the opportunity to try their starting dose (3.75 mg phentermine/23 mg topiramate) in a free trial and their recommended dose (7.5 mg phentermine/46 mg topiramate) at a discounted price.

www.diaTribe.us


7

Qsymia is a weight management medication meant to be taken in conjunction with a weight loss plan and physical activity. Qsymia showed strong effectiveness in late stage trials, with patients losing 25 pounds on average. It is indicated for those who have a BMI above 30 kg/m2 or a BMI above 27 kg/m2 with at least one weight-related medical condi-tion (high blood pressure, type 2 diabetes, etc.). For more information on the drug, see our past articles on Qsymia or www.Qsymia.com. –MN

Logbook

T1/2 Salt, Sugar, Fat: A Food Culture in Need of Changeby James S. Hirsch

Years ago, in one of his stand-up routines, Jay Leno told of how he saw a can of “Cheez Whiz” at a convenience store.

“Here’s what I want to know,” Leno said. “How much ‘whiz’ is in ‘Cheez Whiz’?”

A better question nowadays might be: “How much ‘cheese’ is in ‘Cheez Whiz’?”

The answer: not much, and maybe none at all. It had real cheese when it was introduced in 1953, but cheese is no longer listed as an ingredient – a reformulation, apparently, to boost profits, if not taste. The food scientist who invented the spreadable says it now tastes like “axle grease.”

In Search of the “Bliss Point”

So reports Michael Moss in Salt Sugar Fat: How the Food Giants Hooked Us. An inves-tigative reporter for The New York Times, Moss takes long, relentless aim at processed foods and sugar-sweetened sodas, through which the unholy trinity of health hazards (salt, sugar, fat) is poisoning our diet. The villains in this tale are the mega food compa-nies that shamelessly market their products to children, misrepresent or deceive with their labeling, and spare no expense to bring consumers to their “bliss point.” No, that is not a reference to a spiritual epiphany or sexual ecstasy, but something better – as Moss writes, “the precise amount of sugar or fat or salt that will send consumers over the moon.”

With brain scans showing that humans are hard wired for decadent foods (so are rats), we are at a massive neurological disadvantage in resisting Krispy Kremes and Big Gulps and Frosted Flakes. Food companies, Moss explains, have “discovered that the brain lights up for sugar the same way it does for cocaine.”

Propelled by an excerpt in the Times, Salt Sugar Fat became an instant best-seller, and Moss himself has made the media rounds to explain how food makers and their lobbyists, in cahoots with supermarkets and with the acquiescence of government, are seducing us to put ever more empty calories into our bodies. “There is nothing accidental in the gro-cery store,” Moss writes. The processed foods and sugar-sweetened sodas “are knowingly designed – engineered is a better word – to maximize their allure.” The title of Chapter 1: “Exploiting the Biology of a Child.”

www.diaTribe.org

Salt Sugar Fat: How the Food Giants Hooked Us is written by The New York Times investigative reporter, Michael Moss.

www.diaTribe.us

Implications for Diabetes

Is any of this relevant to the diabetes world? I think yes. Food, of course, plays a central role in the disease, as our high-calorie culture has contributed the obesity epidemic that is driving type 2 diabetes while complicating the efforts of anyone with diabetes to maintain normal blood sugars. By focusing on the apparently addictive properties of processed food – and the willful efforts by companies to manipulate those properties – Salt Sugar Fat shifts responsibility away from the individual and implies that more direct interven-tion by government is necessary. The book is part of a slow but growing movement, evi-denced most recently by New York Mayor Michael Bloomberg, to change our acceptance of junk food as an immutable fixture of our nutritionally deprived landscape. If that ever happens, the diabetes world would be the better for it.

Free Candy

A quick anecdote: My hometown outside of Boston has a Walgreens, and like any retail drugstore, it displays all kinds of candy and wrapped cookies, brownies, or even cupcakes right next to the cash register. You can’t buy anything in this Walgreens without being tempted to purchase its most unhealthy products. Fair enough. We live in a free country with free markets, and if this is how Walgreens wants to maximize its profits, so be it.

But last year Walgreens began offering a promotion: “buy one candy bar, get a second one free.” The cashier, in fact, encouraged me to take advantage of the free candy. It is one thing to make Hershey bars cheap and accessible, but now the drug store is literally giv-ing them away. Which raises a question: if a convenience store had that same promotion for a pack of Marlboros, or if a liquor store had that promotion for a bottle of Jim Beam, what would the response be? I suspect, outrage. We will permit those sales of tobacco and liquor to qualified buyers, but any seller who tried to give them away for free would be pil-loried, and it would be bad for business.

That is the subtext to Salt Sugar Fat. The volume itself doesn’t really break new ground. Other books have described the transformation of our diet through a blend of sophisti-cated food science and brilliant marketing, combined with an understanding of how our brains and emotions work. Salt Sugar Fat hews closely to that science, but what stands out is how deeply it reaches into the companies themselves in explaining their dogged ef-forts to increase consumption of Banana Split Crème Oreos and Chocolate Marshmallow Kisses and Stacy’s Cinnamon Sugar Pita Chips.

Getting Addicted to Salt

For example, Frito-Lay’s former chief scientist showed how the company used math-ematical equations to manipulate the high salt and fat content in chips to create the “ideal snack” – ideal for sales, that is, not health. (“People get addicted to salt,” the food sci-entist acknowledges to Moss.) Scientists at Nestle are fiddling with the distribution and shape of fat globules to affect their absorption rate and “mouth feel.” Self-delusion also seems part of the mix. The inventor of Oscar Mayer’s “Lunchables,” a nutritional disaster for children, showed Moss the company records that described the fat-laden meat and cheese with innocuous terms like “product delivery cues.”

Then there is Cargill, which is altering the physical shape of salt so it hits the taste buds faster, improving what the company calls its “flavor burst.” Cargill, in fact, earns the tri-fecta – it is the world’s leading provider of salt and also produces sugar and fat. And with $134 billion in annual revenue, it sells them all with zeal. So promiscuous is the overcon-sumption of its products that by the time Cargill is introduced in the book, it might as well be selling nuclear missiles to the Taliban.


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What stands out

about Salt Sugar

Fat is how deeply

it reaches into the

companies themselves

in explaining their

dogged efforts to

increase consumption

of Banana Split Crème

Oreos and Chocolate

Marshmallow Kisses

and Stacy’s Cinnamon

Sugar Pita Chips.

www.diaTribe.org

“There is nothing

accidental in the

grocery store,” Moss

writes. The processed

foods and sugar

sodas “are knowingly

designed – engineered

is a better word – to

maximize their allure.”

www.diaTribe.us

9


The country’s overall nutrition numbers tell the story: Americans now eat 33 pounds of cheese and cheese products per year, per person, which is triple the consumption rate of the 1970s. We now consume 22 teaspoons of sugar a day, three times as much as we did in 1970.

The Tobacco Model

So where does that leave the diabetes community? For all the evidence he’s marshaled, Moss himself does not offer any real recommendations, beyond saying that we have the power to buy these products or not buy them. The deeper question is whether salt, sugar, and fat will ever occupy the same place in our consciousness as tobacco – products deemed worthy of restriction and subject to special taxes or other punitive measures to reduce consumption.

The challenge, compared to tobacco, is obvious. Cigarettes are a discreet, identifiable item smoked for pleasure. Once a national consensus emerged that they were addictive and should be restricted, the policies to curb advertising and sales were relatively easy to implement. Salt, sugar, and fat, however, are all necessary to survive. It is their overcon-sumption that is dangerous. You could ban the advertisement on kids’ TV shows of, say, Coke and Snickers, but what about potato chips, fruit juices, and McDonald’s? They can be just as unhealthy.

Any government intervention would necessarily be arbitrary – and that is precisely what undid Mayor Bloomberg’s effort to ban in New York sugar-sweetened sodas larger than 16 ounces sold by restaurants, movie theaters, push carts, and sports areas. A Manhattan judge ruled the policy “arbitrary and capricious.” The outcome was also a reminder of the power of the food and beverage industries, which opposed the ban. The mayor vows to fight on.

Recommendations for Change

Not all is lost. A former Kraft executive named Michael Mudd, whose efforts to reform his company were featured in the book, believes we have several options to improve the qual-ity of our foods. As he recently wrote in The New York Times, we could make the follow-ing changes:

• Levy federal and state excise taxes on sugar-sweetened beverages and a few categories – snack foods, candy, sweet baked goods – that most undermine health. (He doesn’t say how such a tax would be implemented.)

• Federal guidelines for marketing food to children were proposed as voluntary in 2011 but, thanks to food industry lobbyists, they were blocked by Congress. Revive those guidelines and make them mandatory.

• Communicate more actively through prominent disclosure of calories on menus and vending machines and front-of-package labeling systems to encourage healthier food choices.

None of these would be easy to adopt or implement, and as a country, I don’t believe that we are ready to embrace them. What is most important for now – and what Salt Sugar Fat might contribute to – is a change of attitudes toward these products. Smoking has declined in part because it has been stigmatized. We don’t need to stigmatize all pro-cessed foods and sodas, but we do need to associate public scorn with the 32-ounce soft drinks, oversized cookies, and the most egregious examples of salt, sugar, and fat poison-ing our diet. Ideally, laws would not prohibit drug stores from giving away chocolate bars. Embarrassment would.

9

We now consume 22

teaspoons of sugar

a day, three times as

much as we did in

1970.

The deeper question

is whether salt, sugar,

and fat will ever

occupy the same place

in our consciousness

as tobacco – products

deemed worthy

of restriction and

subject to special

taxes or other punitive

measures to reduce

consumption.

www.diaTribe.org

What is most

important for now –

and what Salt Sugar

Fat might contribute

to – is a change of

attitudes toward these

products.

www.diaTribe.us

10


adam’s corner

Can Getting More Sleep Improve Blood Sugar Control? What One Month of Tracking My Sleep Revealed

by Adam Brown

Twitter summary: Get more sleep! I use more insulin+ have worse BGs w/ less sleep. Academic studies show less sleep negatively impacts diabetes+much more.

“Adam, you can sleep when you’re dead,” said one of my friends who seemed particularly fond of sleep deprivation. Funny, but I couldn’t help recalling the years of advice we’ve all heard to get more sleep. So I began wondering – is the more-sleep bandwagon just public health rhetoric, or is there really something to it?

In the past few months, this issue has gained a lot more atten-tion, (see below), especially as sleep relates to diabetes. This article summarizes my personal experience tracking my own sleep over the past two months, a research review of sleep and diabetes, and strategies to improve your sleep.

The Surprising Results from Tracking My Sleep

I recently visited a friend who works for Teach for America in Miami. His schedule requires him to wake up before the sun rises, meaning a lot of very tired mornings. He’s a big fan of an iPhone app called Sleep Cycle, and after he told me about it, it got me hooked. The app uses the iPhone’s accelerometer to sense movement as you sleep, and it has two great features: 1) it allows you to track your sleep very easily, and 2) it has an “intelligent” alarm clock that awakens you when you’re in light sleep.

The ability to easily and painlessly track my sleep was my favorite part of the app. It gives time in bed and a “sleep quality score” (0-100%). To assess the impact of sleep on my dia-betes, I compared my Sleep Cycle data to my blood glucose and insulin pump data. The results of tracking my sleep over a month were fascinating. While I cannot say the results below show a causal effect (formal academic studies below do that), I believe two things back them up: First, I tested for nearly a month, meaning day-to-day variability washes out over time, at least to some extent. Second, I generally keep my diet/exercise consis-tent and independent of my sleep (i.e., on days when I feel tired, I generally eat the same things and exercise the same amount). The results also back up my anecdotal experience.

I needed 24% more insulin on days following less than seven hours of sleep – in other words, the less sleep I got, the more insulin resistant I was. On nights with less than seven hours of sleep, I used an average of 31 units of insulin the following day, compared to an average of 25 units of insulin on days when I get more than seven hours of sleep. Based on all the research I read on sleep and diabetes, this was the result I was most expecting to see.

My highest blood glucose of the day was even higher on days following little sleep. My maximum blood glucose averaged 180 mg/dl on days following less than seven hours of sleep, compared to 163 mg/dl when I got more than seven hours of sleep. Since

T1/2

www.diaTribe.org

The less sleep I got,

the more insulin

resistant I was.

To assess the impact

of sleep on my

diabetes, I compared

my Sleep Cycle data

to my blood glucose

and insulin pump data.

The results of tracking

my sleep over a month

were fascinating.

www.diaTribe.us


11

I always control pretty tightly to a target blood glucose of 100 mg/dl, I did not expect to see dramatic differences in overall average blood sugar – indeed, my glucose averaged 112 mg/dl on days following less than seven hours of sleep vs. 107 mg/dl following seven or more hours of sleep.

My glucose was 21% more variable when I did not sleep enough. My standard deviation of blood glucose was 44 mg/dl on nights with less than seven hours of sleep compared to 36 mg/dl when I got seven or more hours. For those unfamiliar with stan-dard deviation, it’s a statistical measure that some diabetes researchers use to show glyce-mic variability (the ups and downs of blood glucose; more glycemic variability is worse). Many studies indicate higher levels of glycemic variability are associated with negative consequences (e.g., oxidative stress and cardiovascular concerns) independent of average blood glucose. diaTribe columnist and Gary Scheiner recommends aiming for a standard deviation of less than one third your average blood glucose level.

These differences were even more extreme when I compared my best night of sleep to my worst night of sleep. On my best night, I got nine hours of sleep, compared to a little over three hours on my worst night. The real differences came in peak blood sugar, and total daily insulin dose: 146 mg/dl and 23 units of insulin (best night) vs. 204 mg/dl and 35 units of insulin (worst night). My glucose was also 50% more variable following the low-sleep night (a standard deviation of 51 mg/dl vs. 34 mg/dl).

How Much Sleep Do You Need?

Age Sleep Needs

Adults (>18 years) 7-9 Hours

Teens (10-17 years) 8.5-9.25 Hours

School-age children (5-10 years) 10-11 Hours

Preschoolers (3-5 years) 11-13 Hours

Toddlers (1-3 years) 12-14 HoursSource: National Sleep Foundation

What Does Research Say About Diabetes and Sleep?

Just two weeks ago, the CDC released a report called “Insufficient Sleep is a Public Health Epidemic.” Reading the title alone is daunting enough, though the third sentence into the introduction is the real kicker: “Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases such as hypertension, [type 2] diabetes, depression, and obesity, as well as from cancer, increased mortality, and reduced quality of life and productivity.” Yikes. Here’s a smattering of the studies I found linking too little sleep to adverse effects. For a great overview (warning: it’s very science-y) read a free article from the Sleep Medicine Review by Dr. Kristen Knutson and colleagues (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1991337/).

1. Impaired diabetes control: In a 2006 study, sleep duration and quality were “significant predictors” of A1c in 161 patients with type 2 diabetes. In fact, for every three hours of perceived sleep debt (the difference between patients’ preferred and actual amount of sleep), the predicted A1c was 1.1% more than the median. Another study in people with type 2 diabetes asked patients to fill out a sleep questionnaire and compared it to their A1c. Poor sleep quality was “significantly correlated with worse glycemic con-trol.” A different study in young people with type 1 diabetes found that sleepiness and/or poor sleep habits correlated with reduced quality of life, depressed mood, lower grades, and lower standardized reading scores. (All these studies, by the way, were from serious journals and I was excited to see so much learning in this area.)

www.diaTribe.org

Persons experiencing

sleep insufficiency

are also more likely

to suffer from chronic

diseases such as

hypertension, [type 2]

diabetes, depression,

and obesity, as well as

from cancer, increased

mortality, and reduced

quality of life and

productivity.

–CDC“

“

www.diaTribe.us


2. Greater insulin resistance: A study published in Diabetes Care found that one night of four hours of sleep decreased insulin sensitivity by 14-21% in people with type 1 diabetes. In a 2010 study in people without diabetes, results were comparable – just a single night of sleep deprivation caused greater insulin resistance.

3. Weight gain and increased calorie intake: A recently published study is perhaps the best example of this phenomenon. In it, 16 healthy people underwent five days of insufficient sleep (no more than five hours per night) and five days of adequate sleep (up to nine hours per night). The study was impressive in that it tracked participants’ calorie intake in a laboratory setting (where they had unlimited access to food), and the study required each group to undergo periods of both insufficient and adequate sleep. Overall, insufficient sleep led to an average of nearly two pounds of weight gain – astonishingly, that happened over a five-day period! Interestingly, while sleep-deprived participants burned about 5% more calories, they were over-eating above and beyond the increased metabolism. For a more on the study, read coverage from The New York Times (http://well.blogs.nytimes.com/2013/03/18/lost-sleep-can-lead-to-weight-gain/) or the study itself.

Five Strategies to Improve Your Sleep1. Track your sleep. If you have a smartphone, use an app like Sleep Cycle (iPhone)

or Sleep as Android. You might be surprised by what you find. If you don’t, spend 60 seconds a day tracking it when you wake up – write down the time you go to bed each night.

2. Try some quiet meditation. Before I go to bed each night, I spend five or ten minutes sitting up straight with my eyes closed, focusing on my breathing. It’s a won-der how quickly this makes you tired. Sleep Cycle allows you to add custom “Sleep Notes,” and one of mine is meditation. According to the app’s statistic, on nights when I checked the box “Meditated Before Bed,” my sleep quality was about 5% higher. (Sleep quality is calculated based on total time asleep and movement during sleep: for more information see Sleep Cycle’s FAQ.

3. Exercise! If you want a great, low-cost way to feel tired, try some hard exercise! On nights following exercise, I’m always far more tired than when I’m sedentary all day. This is also a sleep note – exercise days tend to boost my sleep quality about 5-10%.

4. Avoid caffeine near bedtime or even in the second half of the day. This tip comes straight from the National Sleep Foundation “Healthy Sleep Tips.” The NSF recommends avoiding caffeine within six to eight hours of going to bed.

5. Optimize your sleeping environment. Tracking my sleep helped me focus on it more than I had in the past. I changed my pillow and bought a warmer blanket, both of which seemed to help me sleep better. Other tips include finding a comfortable mattress, limiting light and screen exposure, and making sure your room temperature is comfortable.

Tracking my sleep over the past month has been a really illuminating and valuable experi-ence. I always knew getting sleep was important, but looking at the numbers and scien-tific research made it crystal clear.

Sweet dreams!

12www.diaTribe.org

Interestingly, while

sleep-deprived

participants were

burning about 5%

more calories, they

were over-eating

above and beyond the

increased metabolism.

Before I go to bed

each night, I spend five

or ten minutes sitting

up straight with my

eyes closed, focusing

on my breathing. It’s

a wonder how quickly

this makes you tired.

www.diaTribe.us

conference pearls

T1/2 Advanced Technologies & Treatments for Diabetes (ATTD) 2013

by Margaret Nguyen, Adam Brown, and Kira Maker

In March, we were privileged to attend the Sixth Annual International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). The conference was held against the beautiful backdrop of Paris, France, and we had a terrific time learning about new diabetes technology and research. The meeting discussed a great number of studies on the artificial pancreas as well as new continuous glucose monitoring (CGM), blood glucose monitoring, and insulin pump technologies, plus a variety of other topics related to diabetes medication and the treatment of complications. The following is our report on the most exciting developments, including new products from Medtronic and CeQur. As a reminder, the artificial pancreas (or “closed loop”) takes readings from a CGM, processes them through a mathematical algorithm, and directs the insulin pump on the dose it delivers. For more information on the artificial pancreas, see learning curve in diaTribe #39.

Artificial Pancreas At Home Studies

Though we have learned about a few overnight and at-home artificial pancreas studies in the US, some ambitious and exceptional studies are being carried out internationally. Three of the most interesting came from Dr. Roman Hovorka’s group at the University of Cambridge in the UK and from the DREAM consortium (Diabetes WiREless Artificial Pancreas ConsortiuM), a group of researchers from three hospital centers in Israel, Slove-nia, and Germany.

30,000 Hours of Closed-Loop System Data

Dr. Roman Hovorka presented the Cambridge team’s work on three home studies using the FlorenceD closed-loop system. FlorenceD uses a first-generation Abbott FreeStyle Navigator, a Dana R Diabecare pump (with Bluetooth), the Companion (an investigation-al device to communicate with the pump), and a small tablet running a predictive algo-rithm. The CGM sends data every minute and automated insulin adjustments occur every 12 minutes. The team’s at-home studies began in July and importantly, have patients wearing the closed-loop system over long periods of time – two of the overnight trials range from three to four weeks (one with adolescents and one with adults) and a third day and night trial lasts for a week. Surprisingly, there is no remote monitoring during the home studies! To ensure safety, Dr. Hovorka and his team conducted extensive computer simulations prior to beginning the studies. Additionally, the participants are extensively trained on how to respond if errors occur during the experiment.

The preliminary results from the study are encouraging. While Dr. Hovorka did not share any statistics on time-in-range (which we were dying to get), the individual patient glucose profiles showed good control with in-range blood sugars. We were impressed, especially given the length of the studies. The system has a few important real-world limitations including the need to carry a tablet, limited battery life, and the need to stop closed-loop control in order to deliver a bolus. We look forward to discovering the stud-ies’ final results and learning how the Cambridge team will improve upon its system and perhaps eliminate these limitations.

13


www.diaTribe.org

ATTD was held in Paris, a beautiful backdrop for our learnings about diabetes technology.

The team’s at home

studies began in July

and importantly, have

patients wearing the

closed-loop system

over long periods of

time – they had two

overnight trials that

lasted three to four

weeks.

Surprisingly, there is

no remote monitoring

during the home

studies!

www.diaTribe.us

The DREAM Team’s Investigations of the Artificial Pancreas

On day one of ATTD, the prestigious New England Journal of Medicine released a pub-lication from Dr. Moshe Phillip (Tel Aviv University, Petah Tikya, Israel) and colleagues’ DREAM 3 study, an artificial pancreas study at an overnight diabetes camp. We first cov-ered this study at last year’s ATTD. It reported significant reductions in hypoglycemia and hyperglycemia when patients were on the closed-loop overnight compared to sensor-aug-mented pumps (SAP). The closed-loop system is called the MD-Logic Artificial Pancreas System (MDLAP), and consists of the Medtronic Paradigm Veo pump, Medtronic Enlite continuous glucose sensor, Bayer Contour-Link blood glucose meter, and a real-time remote monitoring system.

At this year’s ATTD, Dr. Revital Nimri (Schneider Children’s Medical Center of Israel, Petach Tikvah, Israel), presented results from the ongoing DREAM 4 trial. The study advances on DREAM 3 by taking the MDLAP into patients’ homes. Initial results show significantly fewer nocturnal hypoglycemic events: participants using MDLAP spent just 0.6% of their night in hypoglycemic ranges while those on standard pump/CGM therapy had low blood sugars for 9% of the night on average. Time in the range of 70-140 mg/dl was also significantly higher on closed-loop therapy: 57% versus 40%.

We’re pleased to see closed-loop studies moving out of controlled hospital settings and into the real world. We believe the artificial pancreas has potential to improve glycemic control (especially hypoglycemia) while minimizing the burden placed on patients and caregivers. In short, less time thinking about diabetes, and more time living life!

New Devices from Medtronic and CeQur

Many companies displayed their new product prototypes at ATTD in the Exhibit Hall, and Medtronic and CeQur had some of the most exciting developments at the conference.

Medtronic showcased two exciting products we had never seen in person before. The first was a combined CGM sensor and insulin infusion set under a single patch. From a top view, it looks like a CGM transmitter fused with an insulin pump infusion set. The un-derside view looks like an insulin infusion catheter and a CGM sensor separated by about half an inch. The combo set is inserted with a single insertion device. We think patients will appreciate the added convenience of integration and less on-body space – of course, this also means the CGM could only be used for three days, since insulin infusion sites need to be changed every three days. The device is still in development and there is no timeline on when it might be approved.

Medtronic also showed off a mobile hub that wirelessly and automatically sends pump and sensor data to the web-based CareLink platform and smartphone applications. This “Connected Care” system would alleviate the need to manually upload data and could also send alerts to loved ones about high and low blood glucose readings. Like the combo set, there is no timeline on when it might come out, though the potential bodes well for diabetes care being better shared.

CeQur’s PaQ insulin delivery device for type 2 diabetes was another highlight of the ATTD exhibit hall. The round device is about the size of a business card and the thickness of a smartphone, and it holds 330 units of insulin (up to three days). PaQ is a simple patch delivery device that is worn on the body (similar to the OmniPod). It will have a pre-set basal rate and a small on-device button that can press through clothing to deliver boluses. This insulin delivery device received a CE Mark for approval in Europe in late November 2012; we are awaiting further word about the US regulatory process.


14

Participants using

the artificial pancreas

spent just 0.6%

of their night in

hypoglycemic ranges

while those on

standard pump/CGM

therapy had low blood

sugars for 9% of the

night on average.

www.diaTribe.org

Medtronic’s integrated CGM sensor and infusion set that has both insertion sites under one patch.

Medtronic also displayed its Connected Care system that automatically uploads data and sends alerts about high and low blood glucose readings to caregivers.

www.diaTribe.us

For most people with type 2 diabetes, insulin pump therapy does not require all the custom features that pumps for type 1 diabetes normally have. However, there is only one other simplified insulin delivery device on the market: Valeritas’ once-daily V-Go Dispos-able Insulin Delivery Device. Considering that over 50% of 502 type 2 patients in one sur-vey reported skipping injections occasionally (20% omitted doses regularly), we’re always excited to see new delivery devices that make taking insulin easier.

conference pearls

T1/2 The Partnership for a Healthier America’s Building a Healthier Future Summit 2013

by Margaret Nguyen and Adam Brown

The Partnership for a Healthier America (PHA) held its second Building a Healthier Future Summit on March 7-8, 2013, in Washington, D.C. The meeting addressed a chal-lenging problem: how we can end childhood obesity. We enjoyed a celebrity-filled lineup of speakers that included First Lady Michelle Obama, Newark Mayor Cory Booker, and New York Giants quarterback Eli Manning (go to https://www.youtube.com/watch?v=WZw0Aw_jbbI to for the summit’s speeches).

Michelle Obama – How We Can Help Parents Improve their Children’s Health

Mrs. Obama was the most highly anticipated speaker for the summit. Her speech focused on three major topics: parents have the biggest impact on children’s nutrition and activ-ity; marketing healthy foods is responsible and profitable; and parents are role models and should care for their own health too. The continued theme during her talk was that parents, who are incredibly busy raising a family, are the ones who make most of the health decisions for children. She believes the public and private sectors can work togeth-er to make “the healthy decision the easy decision,” especially through smart marketing. Collaborating with PHA, businesses like Darden Restaurants, Disney, and Walmart are prioritizing healthier foods through selecting products they choose to advertise and how they feature them. These companies are still in the initial stages of the changes they can make, but we salute the early steps they have taken to promote healthier choices.

The First Lady also discussed encouraging policies and programs that are now in place. The Let’s Move! Active Schools initiative will invest more than $70 million dollars to pro-mote physical activity and to bring PE back to schools. Additionally, Reebok announced a “groundbreaking investment” of $30 million over the next three years to expand their support of organizations and initiatives that engage children and adults in physical activ-ity. They are also renewing their pledge to the BOKS kids program. This is a before-school program that gets kids active before classes, and it’s based on research that shows physi-cal activity helps students learn better in schools.

Her last message was a reminder to parents not to forego caring for themselves. She em-pathized with parents as she reminded everyone (to laughter) that she “didn’t always live in the White House.” She remembered when “a grocery shopping trip required a finely honed plan of attack.” Mrs. Obama explained that she understands the pressures parents face to truly take care of everything for their families, from the financial costs of providing for a family to safeguarding their children’s health. At the same time, she asked that we re-orient this type of thinking and “make being healthy truly a family affair.”

15


www.diaTribe.org

First Lady Michelle Obama spoke at the Building a Healthier Future Summit and talked about the different ways in which we can work together to end childhood obesity.

www.diaTribe.us

All Star Speakers

Mayor Booker gave one of the most rousing speeches of the conference, emphasizing how pressing and important the issue of childhood obesity is. As he explained it, obesity is “eating away at the foundations of our children, consuming their potential and their dreams, raising the costs of living, [and] lowering the quality of life.” Despite this grim outlook, he cautioned against cynicism, and argued that it is not a question of “can we?” but “do we have the collective will?” to better the health of our nation’s children. Last, he called for setting specific and actionable goals for public-private partnerships. This was certainly a theme of the conference and the primary goal of PHA.

During the summit, Reebok also announced its dedication to help children become more active with talks by BOKS Founder and Executive director Kathleen Tullie and BOKS Ambassador Eli Manning. Both speakers were welcomed with loud applause for their involvement in the program. The before-school program was available in 200 elemen-tary schools in 2012, and Reebok has promised to help expand BOKS to more than 1,000 schools by 2015. With less than 4% of elementary schools providing daily physical educa-tion and only 57% scheduling a regular recess, BOKS serves a huge unmet need for young students to have more daily physical activity. Reebok has already donated $5 million to BOKS over the past three years and has pledged to commit $2 million each year (of its $30 million total dontation) over the next three years to ensure that BOKS is able to expand to its target number for schools.

60 Minutes of Exercise a Day for Kids

Dr. Howard Koh (MD, MPH), the Assistant Secretary for Health in the US Department of Health and Human Services, introduced a session on the 2008 Physical Activity Guide-lines Midcourse Report. These guidelines for children and adolescents recommend at least one hour of physical activity a day. The Midcourse Report identified evidence-based strategies to increase physical activity among youth. A 2011 survey of students from the Youth Risk Behavior Surveillance System found that 42% of children and only 8% of ado-lescents practiced moderate- to vigorous-intensity physical activity for 60 minutes each day in five of the past seven days before the survey. It is clear that increasing exercise time should be a major goal for all caregivers and that we still have a long ways to go in order to reach it.

The report also has a corresponding one-page infographic and factsheet that can help parents and schools. It summarizes the key findings and guidelines in the report, and can provide caregivers with a better understanding for how much physical activity their kids should engage in. Though this information applies to our children, it’s a reminder of how important physical activity is for all of us.

From One Mom to Another – A Parent’s Take on Michelle Obama’s SpeechBy Catherine Newman

Catherine Newman edits ChopChop, an award-winning nonprofit magazine with a mis-sion to inspire kids to cook real food with their families. She is also the author of Waiting for Birdy, the etiquette columnist for Real Simple, a contributing editor at FamilyFun, and the blogger behind benandbirdy.blogspot.com, where she writes about parenting her kids and feeding her family.


16www.diaTribe.org

A 2011 survey of

students from the

Youth Risk Behavior

Surveillance System

found that 42% of

children and only

8% of adolescents

practiced moderate-

to vigorous-intensity

physical activity for 60

minutes each day.

It is not a question of

“can we?” but “do

we have the collective

will?” to better the

health of our nation’s

children.

www.diaTribe.us

I got to meet up with Kelly and her crew at the Building a Healthier Future Summit in Washington DC, and it was a fantastic couple of days of focusing on the health and well-being of our country, our kids, and ourselves. We shared lots of information, listened to many experts, and mostly (if I can speak frankly here) waited for the closing event, which involved all of us getting to see Michelle Obama speak.

As I listened, boy, was she playing my song. The theme of her talk was parents – us – as the first and best role models for our kids: “At the end of the day,” she said, “when it comes to the health of our kids, no one has a greater impact than each of us do [does] as parents. We know that families play a uniquely important role in the work that we’re all doing. And that’s one of the things I want to focus on today – what all of us can do to bet-ter empower families who want to make healthy choices for their kids.” To that end, she explained, “One of the most important things we can do for our children’s health is take care of our own health.” Which is not, of course, breaking news – but it is always a little bracing to be reminded of it, right? This quote, in particular, reaffirmed my great love for the First Lady: “We can’t lie around on the couch eating French fries and expect our kids to eat carrots and run around the block.” Bummer.

When my kids were small, I used to think of my obligation to myself in terms of that airplane-mandated suggestion to “put on your own oxygen mask first before helping oth-ers.” “Exactly,” I would think, as I ate a slice of cold pizza, standing in front of the open refrigerator, while some baby or other complained from the kitchen floor. “I will help you next,” I thought, as I brewed a second cup of coffee before pushing peas and carrots through a strainer, pouring out Cheerios, and scrambling an egg into tender, protein-rich curds. And yet, I could go an entire day up until dinner time without ever sitting down to eat anything. I could – and still can – feel paradoxically too stressed to pursue the very thing (yoga, say, or a run) that would most relax and energize me. I could – and thank-fully don’t any longer – eat all of somebody’s leftover Goldfish crackers while they were napping and call it lunch. We all talk the talk, right? But it’s still so hard to take care of ourselves in the way that would truly enable us to take the very best care of our kids, and to model for those kids the exact healthy habits we would give anything for them to have. And I’ll tell you this: get in the habit of eating healthy, because the older your kids get, the more they watch and understand, and the more inclined they will be to actually – and yes, both my 10- and 13-year-old have done this – call you a hypocrite.

So please, if not for you then for your kids: Commit to three healthy meals a day. (I often eat what I call “Mama Lunch” in the middle of the day: it’s a ginormous salad I make in a 8-quart stainless-steel mixing bowl, filled with chopped kale, canned tuna, sliced celery, pickled jalapenos, pinto beans, feta, and other weird stuff I like, because the kids aren’t eating it!) Commit to half an hour of movement, even if it’s walking your kids into town to look at comic books or doing the Sweatin’ to the Oldies Richard Simmons exercise tape you keep renewing at the library. Commit to snacks that fuel rather than deplete you. Mrs. Obama describes “real and meaningful change” as “our moral obligation to our children” – it is, and we know that. Which is why when I arrived home, I did the very thing I’m always recommending other people do: I gathered, prepped, and made all of my favorite healthy snacks so that, when hunger strikes, I won’t raid the goody bags my kids brought home from a birthday party. Role modeling 101, but you have to start somewhere.


17www.diaTribe.org

When it comes to

the health of our kids,

no one has a greater

impact than each of us

do [does] as parents.

– Michelle Obama““

One of the most

important things

we can do for our

children’s health is

take care of our own

health.

– Michelle Obama“

“

Commit to half an

hour of movement,

even if it’s walking

your kids into town to

look at comic books

or doing the Sweatin’

to the Oldies Richard

Simmons tape.

www.diaTribe.us

Roasted ChickpeasRoasted chickpeas are one of my very favorite snacks: they’re cheap, they’re addictively tasty, they’re full of protein and fiber, and they have a glycemic index that is nice and low. Also, they’re a fantastic substitute for croutons in a salad. I’m in love with Old Bay sea-soning right now, because no matter what I put it on, it ends up reminding me (in a good way) of peel-and-eat shrimp. If that doesn’t speak to you, use a different seasoning – I made them with curry powder for years before trying something new.

Ingredients

1 (15-ounce) can chickpeas, drained, rinsed, drained again, and spread on paper towels to dry

Olive oil cooking spray

½ teaspoon kosher salt (or more to taste)

Optional seasoning of your choice: Old Bay, curry powder, garlic powder, chili powder, etc.

Directions

Heat the oven to 350oF. Spread the chickpeas on a foil-lined rimmed baking pan, spritz them with the cooking spray, and shake them around. Bake them for about an hour to an hour and a half, shaking the pan once or twice so that they brown evenly. When they’re done, they should be quite brown and crunchy. Spritz them again with the oil, shake them around, and then add the salt and a few dashes of your seasoning. Pop back in the oven for 3 minutes, then cool (or don’t) and eat!

Makes about 1 cup, which is four dense servings. (There are 1.5 cups of chickpeas in the can, but they shrink when you roast them.)

Glycemic Index: 28

Carbohydrates: about 15 grams of carbohydrates and 5 grams of fiber per 0.5 cup serving

trial watchEfficacy and Safety of Lixisenatide Versus Apidra (Insulin Glulisine) on Top of Lantus (Insulin Glargine) with or without Metformin for Type 2 Diabetes (GetGoal Duo-2)

ClinicalTrials.gov Identifier: NCT01768559http://www.clinicaltrials.gov/ct2/show/NCT01768559

This phase 3 trial compares lixisenatide (Lyxumia, a once-daily injectable GLP-1 agonist) against a rapid acting meal-time insulin (Apidra, insulin glulisine) for how well they can improve A1c and weight for type 2 diabetes. These drugs will be taken in addition to Lan-tus (insulin glargine) and perhaps metformin, depending on the medications the partici-pants’ already take. The basic idea is to see if a GLP-1 agonist can regulate blood sugars after meals either the same or better than a rapid-acting insulin analog. This would give patients more choices for medications.

T2

18


www.diaTribe.org

Is a GLP-1 agonist

better than a ultra-

rapid insulin analog?

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In the study, participants using Lantus will either add lixisenatide once a day, Apidra once a day, or Apidra three times a day. The study lasts for 41 weeks with a 26-week treatment period. In order to enroll in the study, participants must be 18 years or older, have been diagnosed with type 2 diabetes for at least one year before their screening visit, taking a basal insulin for at least 6 months, and have a stable basal insulin regimen within the last three months, among other criteria. The exclusion criteria include being younger than 18 years old, having an A1c of less than 7.5% or greater than 10% if taking a basal insulin alone or with metformin, having an A1c outside of 7.5-10% if taking a basal insulin with another oral antihyperglycemic drug (e.g., a sulfonylurea or DPP-4 inhibitor), and others listed on the trial site. There are 33 locations recruiting for the study in AZ, AR, CA, CO, GA, IL, IN, KS, MD, MI, NJ, NY, NC, OR, PA, TN, TX, VA, and WI as well as sites in Canada. If interested in enrolling, please send an e-mail with your site number found on the ClinicalTrials.gov site to [email protected]. –MN

Identifying Driving Risk Factors in Type 1 Diabetes and Their Reduc-tion via Internet Program (DiabetesDriving.com)ClinicalTrials.gov Identifier: NCT01563887

http://clinicaltrials.gov/ct2/show/NCT01563887

Hypoglycemia is the largest risk associated with insulin therapy and it can cause danger-ous problems with daily tasks such as driving. Researchers at the University of Virginia are studying how to prevent hypoglycemic events while patients are driving. The goal of this study is to determine if online classes focused on reducing hypoglycemia while driving can help decrease the number of related driving accidents. The study lasts for two years; participants attend five one hour classes for eight weeks, update driving journals once a month, and complete three driving surveys. In order to participate in the study, volunteers must be 18-70 years old, have been diagnosed with type 1 diabetes for at least one year, have started taking insulin within a year of being diagnosed, measure blood glucose at least twice a day, and have internet access, among other criteria. The following characteristics disqualify you from the study: having type 2 diabetes, not taking insulin, not driving, not having a driver’s license, and not having access to the internet. If inter-ested in enrolling, please contact Dr. Thomas Banton at [email protected], and read their ClinicalTrials.gov site or their study’s site for more information. –MN

T1


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How can we prevent

hypoglycemia while

driving?

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in this issue from the editor e - diatribe · – dean kamen (president, deka research &...

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