NEWSLETTERMY

A typical study evaluating a drug for people with type 2 diabetes will involve a placebo, or dummy pill, as well as the actual drug. These types of studies are referred to as “double blinded.” The research subjects, the investigators, and the nursing staff do not know which (the drug or the placebo) was given to each study participant. This eliminates any potential bias and makes the data more meaningful.

Before any clinic or institution starts a clinical trial, an official independent body

called the Human Subjects Committee evaluates the study for safety based on early animal and human laboratory studies. Typically, these are done well before the large studies that you hear about. These committees and boards are very strict and will not allow any further study to be performed without the proper precautions in place and prior data showing its safety. In addition to that, each study has an External Data Safety Monitoring Board that has access to the data as the study proceeds

Fall 2013 Volume 45

Becoming a Research Subject (continued on page 2)

Dr. Edelman’s Corner

It’s Not Guinea Pig Stuff Anymore! The Pros and Cons of Becoming a Research Subject

In order for the pharmaceutical industry and device companies to get their products approved by the Food and Drug Administration (FDA),

they have to perform clinical trials with hundreds and often thousands of people at research sites across the United States and around the world.

INSIDE

Navigating the Maze of a Food LabelPage 3

The GRAde StudyPage 4

Giving Back Page 5

The Jerry Lund Story, Final InterviewPage 6

Ask A Pharmacist Page 8

Question of the Month Page 9

A Pathway to PreventionPage 10

Know Your NumbersPage 11

and they have the authority to stop any clinical trial if they see a safety problem. They can also stop a study if the results are so positive that it is just a waste of time to delay the findings. The entire process is extremely meticulous, decisions are made very carefully, and there is an enormous amount of detailed data analysis.

Well…what’s in it for you? Research advances our knowledge of medicine and the potential to have superior drugs and devices for people with type 1 and type 2 diabetes. There are also many personal benefits when it comes to getting involved. • You typically get a free, full history and

physical exam as well as an executive type of laboratory workup including: a chemistry panel, lipids, A1C, complete blood count, electrocardiogram, chest X-ray, etc.

• Very often you will receive glucose testing supplies if it pertains to the study and access to caregivers who know a lot about diabetes.

• Most studies will pay you a stipend for your time and travel expenses.

• If you do not have health insurance or good coverage with a large donut hole* (I love donut holes…especially the ones with the sprinkles) getting involved in a clinical study is really awesome.

• Often times people improve their A1C merely from the attention they get from the clinical research staff, even the placebo group.

What is the down side of getting involved in a study? • It is time consuming,

especially in the beginning. However, you are paid for every visit

2 My TCOYD Newsletter, Vol. 45

Board of directorsSteven V. Edelman, MD Founder and Director, TCOYD

Sandra Bourdette Co-Founder and Executive Director, TCOYD

S. Wayne Kay s2a Molecular, Inc.

Margery Perry

Terrance H. Gregg DexCom, Inc.

Daniel Spinazzola DRS International

Contributing AuthorsJanice Baker, MBA, RD, CDE Jennifer BraidwoodCatherine DeLueSteven Edelman, MDTiep LyCandis M. Morello, PharmD, CDELorrain Stiehl

TCOYd TeamSteven V. Edelman, MD Founder and Director

Sandra Bourdette Co-Founder and Executive Director

Jill Yapo Director of Operations

Michelle Day Director, Meeting Services

Michelle K. Feinstein, CPA Director of Finance and Administration

Antonio Huerta Director, Latino Programs

Jennifer Braidwood Manager, Outreach and Continuing Medical Education

Jimm Greer Manager, Multi-Media

David Snyder Manager, Exhibit Services

Robyn SemberaAssociate Manager, CME and Outreach

MyTCOYd NewsletterEditor: Jennifer BraidwoodAssistant Editor: Robyn Sembera Design: Hamilton Blake Associates, Inc.

MyTCOYD Newsletter is offered as a paid subscription of Taking Control Of Your Dia-betes. All material is reviewed by a medical advisory board. The information offered is not intended to constitute medical advice or function as a substitute for the services of a personal physician. On the contrary, in all matters involving your health, TCOYD urges you to consult your caregiver. ©2013 All rights reserved.

Becoming a Research Subject (continued from page 1)

SpecialAcknowledgements

Steven Edelman, MDFounder and DirectorTaking Control Of Your Diabetes

and the number of visits typically go down over the duration of the trial.

• You will need to get your blood drawn in the beginning, at the end, and sometimes in the middle of a typical study.

• You may be randomized to taking the placebo and not get the potential benefit of the drug being tested. If this happens you probably will not improve as much as the folks taking the drug being tested. However, if for some reason your diabetes control worsens, there are “rescue” protocols in place that will switch you over to the active, or real drug, or allow you to exit the study. There is also a human subjects bill of rights that allows you to withdraw from any study at any time. All of this is explained to you up front before signing up to be a research volunteer.

Now is an excellent time to be a research volunteer. I have been doing clinical research for over 20 years and I have seen so many positive things come out of the research, including advancement in oral medications, designer insulins, devices such as pumps, CGM and HGM, and many grateful subjects. It comes down to being educated about the study, asking questions, showing it to your own provider first, if desired, and weighing the pros and cons of getting involved.

It is not guinea pig research anymore.

* Most Medicare Prescription Drug Plans have a coverage gap (also called the “donut hole”). This means there’s a temporary limit on what the drug plan will cover for prescriptions.

Taking Control Of Your Diabetes 3

increasing the risk of heart and blood vessel diseases. Paying attention to the total fat in a food pays off because fat is the most concentrated source of calories (9 calories per gram). Eating too much fat can lead to unwanted weight gain or make it tougher for you to lose weight.

More on Sodium:In some people, sodium increases

blood pressure because it holds excess fluid in the body, placing an added burden on the heart. If your blood pressure is 120/80 Hg or above, your doctor may recommend a low-salt diet. The American Diabetes Association recommends 2300mg of sodium or less per day. If you have diabetes and hypertension, you should work with your health care team to see if further reduction of sodium intake is necessary.

Food Labeling (continued on page 5)

By Janice Baker, Rd, Cde

Fit to eat

Shopping for food can be stressful, confusing and certainly not

that helpful when it comes to blood sugar control! There are so many claims on food packages these days, such as “made with whole grain,” “lower in sugar,” and “good source of antioxidants.” The real challenge when doing your weekly shopping is to be able to wade through what’s real and what’s totally bogus. False claims can grab your attention, take your money and keep you wondering why your weight or glucose levels are not cooperating!

So, what do those food labels tell us?

Serving Size: Tells you the number of servings in the product

The information noted on the nutrition facts label is for one serving. Some packages and containers (even those that appear to be a single serving) contain more than one serving. Check this space on the label so you know what you are actually consuming.

Calories: Tells you how much energy (calories) is in a serving

The calories listed show the amount of calories in one serving of this food item. The label also shows how many calories come from fat.

Total Fat, Cholesterol, Sodium and Sugar: These are the types of nutrients that are in the product

At the minimum all products must list the amounts of total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugar, protein, vitamin A and C, calcium, and iron that are in one serving.

More on Fat:Under total fat, food labels must

list saturated and trans fat (consume close to zero grams of trans fats per day). These fats are closely associated with raising bad cholesterol levels and

4 My TCOYD Newsletter, Vol.334 My TCOYD Newsletter, Vol. 45

If metformin is not enough to help manage type 2 diabetes, a person’s doctor may add one of several other drugs to lower glucose (blood sugar). But while short-term studies have shown the efficacy of different drugs when used with metformin, there have been no long-term studies of which combination works best and has fewer side effects.

“GRADE is a novel and exciting study which has the potential of changing the future of therapy and management of type 2 diabetes,” said Robert Henry, MD, local principal investigator, chief of Endocrinology, Metabolism & Diabetes at VA San Diego Healthcare System. Also, working closely with Dr. Henry is Dr. Steven Edelman, Founder and Director of Taking Control Of Your Diabetes.

The study will compare drug effects on glucose levels, adverse effects, diabetes complications and

quality of life over an average of nearly five years. Potential participants may be on metformin, but not on any other diabetes medications. During the study, all participants will take metformin, along with a second medication randomly assigned from among four classes of medications, all approved for use with metformin by the U.S. Food and Drug Administration.

Three of the classes of medications increase insulin levels. They are: sulfonylurea, which increases insulin levels directly; DPP-4 inhibitor, which indirectly increases insulin levels by increasing the effect of a naturally occurring intestinal hormone; and GLP-1 agonist, which increases the amount of insulin released in response to nutrients. The fourth type of medication is a long-acting insulin.

The GRAde Study

By Catherine deLue and Jennifer Braidwood

Participants will have their diabetes medications managed free of charge through the study, including at least four medical visits per year.

What differentiates GRADE from previous studies is that it will perform a head-to-head comprehensive comparison of the most commonly used drugs over a long period of time,” said David M. Nathan, M.D., of Massachusetts General Hospital, Boston. Nathan and John Lachin, Sc.D., of The George Washington University, Washington, D.C., are co-principal investigators.

“In addition to determining which medications control blood glucose levels most effectively over time, we hope to examine individual factors that are associated with better or worse response to the different medications,” Nathan said. “This should provide understanding of how to personalize the treatment of diabetes.”

GRADE (ClinicalTrials.gov number: NCT01794143) is supported under NIH grant U01DK098246. Additional support in the form of donation of supplies comes from the National Diabetes Education Program, Sanofi-Aventis, Bristol-Myers Squibb, Novo Nordisk, Merck, BD Medical and Roche Diagnostics.

dr. edelman’s VA San diego Healthcare System begins recruitment as part of a nation-wide long-term study of diabetes drug efficacy

H ave you been diagnosed with type 2 diabetes within the last five years? You might be interested in enrolling in the

Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study. This randomized clinical trial is a multicenter trial that is currently being conducted at 36 clinical sites around the country. The study plans to enroll 5,000 participants in order to compare the long-term benefits and risks of four widely used diabetes drugs in combination with metformin, the most common first-line medication for treating type 2 diabetes.

Learn more about the study and how to become a participant visit: https://grade.bsc.gwu.edu .VA San Diego Healthcare System GRADE study contacts:Catherine DeLue (858) 552-8585 ext. 6740Erik Castro (858) 552-8585 ext. 6449

More on Sugar:The sugars on the

label include naturally occurring sugars, such as sucrose in fruit and lactose in milk, as well as added sugars—those added to products during manufacturing.

As opposed to outdated advice that all sugar is “forbidden,” you don’t need to omit all sugars from your meal plan. Naturally occurring sugars found in fruit and dairy products are part of a well-balanced diet.

% daily Value: Tells you how much you are consuming based on a specific daily percentage

The % daily value is a guide to the nutrients in one serving of the product. For example, if the label lists 15% for calcium,

it means that one serving provides 15% of the calcium you need each day.

The percent daily values are based on a 2,000 calorie-a-day diet for healthy adults.

Footnote: Reminds you that the Percent daily Value is based on a 2,000 calorie a day diet

(continued from page 3)

The footnote contains a statement saying that nutrient values vary by a person’s particular caloric needs. If there is enough space on the package, the footnote includes a list of selected nutrient values for both 2,000 and 2,500 calorie-a-day diets. Keep in mind that many people, including women and older adults, or those trying to lose weight, may need less than 2,000 calories, while others may need 2,500 calories or more. So think of 2,000 calories a day as a general reference point.

Now get your shopping list ready and use this information to make wiser and healthier food choices this month!

Taking Control Of Your Diabetes 5

Walter and Carol McCauley attended their first TCOYD

Honolulu conference in 2003. “A friend of ours, who volunteers

at the TCOYD conferences in Honolulu, approached us and convinced us that we needed to attend the next time TCOYD was in town,” said Walter McCauley, a Maui resident, who has had type 2 diabetes for many years. Walter and his wife Carol have attended

a total of five TCOYD conferences since 2003. “We keep coming back because the conferences help us keep up with the current developments within the field of diabetes. It’s always a good refresher when it comes to diabetes management and keeping up with the best care strategies.”

Walter and Carol have generously donated to

TCOYD many times throughout the years. “We donate because it’s a very worthwhile cause. The staff at TCOYD are extremely dedicated. It’s a small organization, so I know my donations have made, and will continue to make a big difference.”

Because of people like Walter and Carol, TCOYD is able to continue our mission of educating and empowering individuals with diabetes. “People should donate to TCOYD because of the simple fact that it’s a great organization and like I said before, it’s a great cause. There are good people at TCOYD and they are really making a difference in the lives of people with diabetes.”

TCOYD sends a generous thank you to Walter and Carol for their many years of dedication and continued support of our work.

If you would like to make a donation to TCOYD please visit our website at tcoyd.org and click on the “Giving” tab.

By Jennifer Braidwood

“We Keep Coming Back”Giving Back

Interview #6 August 9, 2013Current Weight: 202BP: 122/72A1C: 5.9Total Cholesterol: 155LdL: 91

6 My TCOYD Newsletter, Vol. 45

“It’s been a rough two months. My last interview was in May after my trip to China, when I fell off the wagon and since then, it’s been so hard to get back on. I was having so much success and the success kept coming and coming. I remember thinking, ‘Man, this is great and so easy!’ You know what? I lost focus. I thought I could eat more and snack more. I thought I didn’t have to keep this rigid diet anymore. I was convinced that my metabolism

had changed because of exercise and I was fooling

myself. I got to a place where I was comfortable and, well, I just stopped

doing the things I knew I needed to do. Now, I’m going back the other way.”

For the last 11 months, Jerry has proudly been advertising his weight loss to friends, family, TCOYD, his co-workers and, most importantly, to anyone that

reads our newsletter each quarter. “I’ve stopped telling people. I’m not going to tell anyone I gained a pound or I’ve gained two pounds. So I’ve shut it all off for the last two months,” said Jerry. In reality, it’s not just a pound or two, it’s a whopping seven pounds, and that’s a lot in two months. “Sorry all you people out

there who thought this was so easy. Even though I thought it was different this time, it’s exactly the same as all the other times I’ve lost weight. I’m falling back into my old ways.”

Our Executive Director quickly realized that this interview was going to be vastly different from the five she had done previously. For the first time, Jerry needed some serious help getting back on track and reigniting his motivation. She offered him this bit of advice, “a secret to success is realizing that you are going to fall off the wagon periodically, but, the key is to get back on track quickly. The next time you fall off, find a way to get back on sooner. Things happen, life happens! It’s human nature.” There was silence and then she continued, “it wouldn’t be a bad idea to put those same things in place that you did at the beginning of all of this. Checking in with me every day, calling or texting your doctor on a regular basis. Having the same system in place that really worked.”

It’s important to remember that not every diet and exercise plan is going to be perfect and easy day in and day out. There are going to be days where you don’t follow all the rules, so to speak. The first couple of months are usually the easiest because you’re motivated and excited, but soon enough, like most things in life,

By Jennifer Braidwood

‘‘A TCOYD Extreme Diabetes Makeover:The Jerry Lund Story - Final Interview

I’ve put back on seven pounds.” It was the first thing Jerry Lund said into the tape recorder on August 9, 2013 when Sandra Bourdette,

Executive Director for TCOYD, sat down with him for his sixth interview. The vibrant, bold, and unstoppable Jerry that we have all gotten to know through his Extreme Diabetes Makeover these last 11 months has been dangerously slipping back into his old ways.

Taking Control Of Your Diabetes 7

the novelty wears thin. There is an important lesson we can all learn from Jerry: diet, exercise and living a healthy lifestyle, is a journey with no end, with no stopping point.

“I have to keep moving on and pushing forward. The ultimate goal is to stay on the journey and keep getting healthier. There was a starting point, September 26, 2012, but there is no ending point. It’s not the results, it’s the process and maybe I was focusing too much on the results. Reestablishing a plan and acting on it is what I need to do. I’ll tell you what, when I’m done with this interview I’m going straight to the grocery store do to my weekly shopping.”

“It’s kind of like meeting someone and falling in love. You are so excited at first, everything is new, then eventually you just get used to each other and the novelty wears off,” said Jerry Lund during his final interview. Jerry’s love affair with his revolutionized lifestyle of healthy eating and working-out has officially lost its luster. It’s a very real fact that Jerry’s journey with diet and exercise is no longer intensified by massive drops in weight, waist size, blood sugar and blood pressure. Almost

a year after he started his Extreme Diabetes Makeover with TCOYD he is realizing that he is now embarking on an entirely different journey, a journey that will be much harder than his initial quest to take control of his diabetes, his weight and his life. “The challenge is over. I’m not climbing that mountain anymore trying to reach the top. I’ve reached it.” The daunting question that Jerry faces is, now what? And, the answer to that question is something Jerry is still trying to figure out.

“Losing 70 pounds, that’s exciting. Having your blood sugar go from 180 to 90 and having your blood pressure drop from 160/110 to 120/70, that’s exciting. It was easier to stay focused. The results were great and that added more to my focus, but now it’s completely different. It’s more about the long-term process, about maintenance.” Let’s be honest, maintenance isn’t very exciting and, as Jerry is figuring out, can be difficult. But, it is an absolute necessity when it comes to lasting weight loss and good health. “I need to completely buy into good eating and exercising and understand that it’s not just about losing 70 pounds, following a plan for eight months and then stopping and gaining it all back. I’ve done that plenty of times in the last 40 years. I’m not going to do it this time.”

During the interview, our Executive Director shared her own thoughts with Jerry about the year-long process they went through together. “We are ending this with lots of questions, things to ponder

and a sense of uncertainty as to what exactly the next steps are. We aren’t going to have a tidy little ending to this story because the story doesn’t end. This is the beginning of something new.”

Jerry and Sandy continued to talk about the importance of identifying self-sabotaging behaviors and how pivotal it is to be aware of those behaviors that could potentially lead Jerry back to the person he was before his Extreme Diabetes Makeover. “I do know one thing about myself for sure and that is that I am a closet eater. I’ll only eat a donut when no one else is around. I’ll have a cheeseburger on my way home from work when I’m by myself. Eating bad food when I’m alone is my biggest problem.” The fact that Jerry is able to identify this behavior is a very good thing and will help him continue to have the awareness he needs to recognize these behaviors and not give in as he continues into the next year of his life. “In a year from now, if I am in the shape that I am in now, that would be a very good thing,” Jerry said at the close of his final interview. “I did make a promise to myself that I would never wear elastic shorts again and remember, I sold all my fat clothes!”

Everyone at TCOYD would like to wish Jerry Lund much luck as he embarks on the next year of his life, a new man, who’s a lot lighter and much healthier than he was a year ago. We send lots of encouragement your way and thank you for letting us be so involved in your incredible journey!

Interview #7 September 17, 2013Current Weight: 201BP: 122/72A1C: 5.9Total Cholesterol: 155LdL: 91

8 My TCOYD Newsletter, Vol. 45

P eople with type 2 diabetes just got a brand new oral medication

option for treating diabetes that does not cause weight gain or hypoglycemia (low blood glucose). In March 2013, the FDA approved Invokana (canagliflozin). Along with improved glucose control, Invokana offers the benefits of weight loss and blood pressure reduction.

What is Invokana?Invokana is the

first drug in a new class of diabetes drugs called SGLT-2 inhibitors. It helps rid your body’s excess blood glucose through urination. Invokana has been shown to be more effective at lowering AIC than older drugs like glimepiride and even new ones like Januvia (sitagliptin). Clinical trials showed its A1C lowering abilities to be 0.9-1.2% when used alone, or an additional 0.7-0.9% when added on to other medications, such as metformin. Because of its novel mechanism, Invokana provides two benefits over other diabetes medications. First, Invokana does not work by increasing your body’s insulin levels, so weight gain and risk for hypoglycemia are very low compared to other diabetes drugs. In

fact, most patients taking Invokana reported clinically significant weight loss. Second, through its unique mechanism of action, Invokana can also help reduce blood pressure.

The idea for treating diabetes with an SGLT-2 inhibitor came by studying individuals with a defective SGLT-2 gene. These individuals

with non-functional SGLT-2 transporters had higher levels of glucose in urine, but experienced no long-term consequences. The lack of long-term consequences was the basis for developing Invokana.

How does Invokana Work?

When urine first forms in your kidneys, it is filled with glucose. As urine

travels through your kidneys, this extra glucose is pumped back into the blood by a transporter called SGLT-2. Invokana works by blocking the action of this transporter. By doing so, it allows the glucose to be urinated out and decreases the

overall blood glucose. In addition, blood pressure is lowered because glucose draws water with it into the urine. This reduces blood volume and leads to a decrease in blood pressure.

A common concern might be that glucose in urine damages the kidneys; this, however, is a misconception. High blood glucose damages blood vessels and capillaries, including those in the kidneys. When the kidneys don’t receive enough oxygen, the cells die and holes are formed, which can cause diabetic nephropathy (kidney damage from diabetes).

How Is Invokana Used?Invokana is an oral diabetes

medication used with a healthy diet and exercise. Ivonkana comes as a 100mg and 300mg tablet and should be taken before the first meal of the day. Usually people start with 100mg

Ask a Pharmacist

Table 1. Tips for Preventing Yeast Infections

Personal Hygiene

• Clean genital area daily using a mild, unscented soap and water.

• Use toilet paper by wiping from front to back (away from the genital area).

Clothing • Don’t wear tight fitting clothing.

• Use cotton underwear since it breathes better and won’t hold in moisture.

• Change out of wet clothing or bathing suit immediately.

By Candis M. Morello, Pharmd, Cde, FASHP and Tiep Ly

Urinating down Your A1C

By Steven edelman, Md

Taking Control Of Your Diabetes 9

daily then increase to 300mg daily if a further A1C reduction is needed.

Is Invokana Right for Me?Currently, Invokana is FDA

approved for patients with type 2 diabetes only. People who are likely candidates are those taking more than one oral diabetes medication. Based on clinical trials, Invokana appears to be equally or more effective than old drugs like glimepiride and new ones like Januvia. Patients on these drugs can consider talking to their doctors about switching. Those concerned about weight and blood pressure may also benefit from Invokana’s weight loss and blood pressure lowering effects. Clinical trials showed the drug reduced body weight by 2-3% and blood pressure reduction of about 4mmHg over a six month time period.

Before starting Invokana, have your health care provider do tests on your kidney function and potassium levels. Invokana is not to be used in those with severe renal failure or those with high levels of potassium in their blood, a condition called hyperkalemia.

While Invokana provides many benefits, there are some side effects. The two most common were increased risk for urinary tract infections (UTIs)—especially in those with a history of UTIs—and increased urination. With more glucose exposed to the genital area, some patients, mainly women, may experience yeast (fungal) infections.

Iam a 28-year-old female with type 1 diabetes that was diagnosed 10 years ago. I was recently informed of a study

where I would get Victoza (Note: also called liraglutide, an injectable incretin currently approved for people with type 2 diabetes) or a placebo injection for three months. If I were to become a study participant, I would have access to a continuous glucose monitor as well as all the test strips and I really need a new glucose meter. My A1c is 7.6% and I am 10 pounds overweight but, otherwise, I’m pretty healthy. I do have a general doctor and rarely get to see a diabetes specialist. How do I know if this study is right for me?

Answer: There have already been a few studies using Victoza in folks with type 1 diabetes. Those study results have shown improved A1C, reduced variability of glucose values measured by a CGM device, weight loss and reduced insulin requirements. This has prompted NovoNordisk, the makers of Victoza, to conduct more studies in hopes of an official FDA approval to move forward with the use of Victoza in people with type 1 diabetes. If you get selected for the placebo group and not the actual drug, you probably will not see any major improvements in your diabetes, however, you will get the same free evaluation and supplies as all the other research volunteers. I would suggest looking at the protocol, number of visits, and the safety concerns. Discuss any concerns with the staff and with your own doctor if you want another medical opinion. Once you get all the information you can make an informed decision.

A special thanks to all of our Facebook fans who sent in questions for Dr. Edelman!

Question of the Month

Urination down Your A1C (continued on page 12)

10 My TCOYD Newsletter, Vol. 45

By Lorraine Stiehl

Not only is TCOYD focused on improving

the lives of everyone with diabetes through educational and motivational conferences and continued support, we are committed to bringing new medical advances to patients with diabetes and to help prevent this disease in future generations.

TCOYD is pleased to be partnering with the National Institutes of Health-funded Type 1 Diabetes TrialNet, www.diabetestrialnet.org. TrialNet is a network of 18 clinical centers working with more than 200 screening sites around the world. This network is dedicated to the study, prevention, and early treatment of type 1 diabetes.

delay or Prevent Type 1 diabetes for Individuals At-Risk

Type 1 diabetes is an autoimmune disease in which the immune system attacks and destroys the cells in the body that produce insulin. Proteins called autoantibodies are markers of the destruction. TrialNet offers a screening test that can detect these autoantibodies in the blood up to 10 years before someone is diagnosed with type 1 diabetes. A major goal of TrialNet is to delay or prevent diabetes in

individuals who have these autoantibodies.Relatives of

individuals with type 1 diabetes have approximately 15 times greater risk for developing the disease than individuals with no family history. TrialNet offers the screening blood test at no cost to family members of individuals with type 1 diabetes.

Your relatives may be screened if they are:• 1 to 45 years old and have a

brother, sister, child, or parent with type 1 diabetes (first degree relative)

OR• 1 to 20 years old and have a

cousin, aunt, uncle, niece, nephew, half-brother, half-sister, or grandparent with type 1 diabetes (second degree relative).

Your relatives will learn the results of their blood test in four to six weeks.

Only 5 out of every 100 people tested will have autoantibodies and children under 18 years of age who do not have autoantibodies may be retested every year to see if their risk has changed. If their blood tests show that they have autoantibodies,

TrialNet will invite them to have further blood testing at a study center. These tests will tell TrialNet if they can join a prevention study.

TrialNet’s Pathway to PreventionIf your relatives are found to be at risk

for developing type 1 diabetes, a number of prevention studies are in progress.

Oral Insulin Prevention Trial— For Individuals at Moderate Risk

TrialNet is repeating an earlier study using oral insulin (taken by mouth, not by injection). The prior study (completed by the Diabetes Prevention Trial-Type 1) suggested that oral insulin may help delay type 1 diabetes for four or more years in individuals with higher levels of insulin autoantibodies. Volunteers who join this study will take one capsule each day for a limited time, visit a study site for blood tests every six months, and return at other times as needed.

CTLA-4 Ig (Abatacept) Prevention Trial—For Individuals at Moderate Risk

Abatacept (also known as Orencia) is currently approved by the US Food and Drug Administration (FDA) for treatment of rheumatoid arthritis which is an autoimmune disease like type 1 diabetes. In a prior TrialNet study, subjects with newly diagnosed type 1 diabetes who received Abatacept kept producing their own insulin longer than people in the study who did not receive Abatacept. Volunteers who qualify and are enrolled will receive 14 doses of Abatacept or placebo over the course of 12 months. The drug will be given through a vein (IV infusion) over 30 minutes. All volunteers will be monitored one to five years after the treatment

TCOYd in Motion

A Pathway to Prevention

By Steven edelman, Md

Taking Control Of Your Diabetes 11

Taking Control Of Your Diabetes is Generously Supported By:

Silver Corporate Sponsors

Platinum Corporate Sponsors

Gold Corporate Sponsors

Know Your Numbers

A 15-year-old boy who has had type 1 diabetes since the age of six is treated with Lantus at bedtime. Additionally, he carefully and accurately

figures out how much Novolog he needs to take before each meal by counting the carbohydrates in that meal. His CHO:insulin ratio is 1:10. By taking a look at his logbook you can see that his post-breakfast numbers are through the roof almost every day (commonly above 300 mg/Dl).

Breakfast Lunch dinnerBefore After Before After Before After

SAT 121 362 186 161 179SUN 97 410 159 212 187

MON 116 299 113TUeS 159 351 149Wed 126 320 225 118THUR 84 281 261 145

FRI 162 427 144 197

After a thorough dietary history, it was discovered that his typical breakfast consisted of orange juice (8 oz), a bowl of cold cereal (his favorites are Trix and Captain Crunch) with 1% milk, and two pieces of toast with diet jelly.Potential solutions for bringing down his post-breakfast numbers are:• More protein in the meal and less refined carbohydrates• Change the CHO:insulin ratio• Add Symlin before breakfast and, potentially, his other meals, too

period to assess their overall health and to determine the effects of the treatment to their immune system and beta cells.

AntiCd3 (Teplizumab) Prevention Trial – For Individuals at High Risk

Teplizumab is a medication that has shown promise in preserving insulin secretion in people with newly diagnosed type 1 diabetes. This study is testing whether Teplizumab can help to delay or prevent the onset of diabetes in individuals at high risk. Volunteers who join the study will visit a TrialNet site to receive the two-week study treatment. They will return for follow-up tests and monitoring approximately every six months.

All study volunteers may be eligible for reimbursement for time, effort and travel expenses.

TCOYd National Conference Screening Opportunities

TCOYD has arranged for TrialNet to screen at all of our upcoming TCOYD National Conferences.

If you have family members who are not within driving distance of one of our TCOYD National Conferences, TrialNet screening locations may be found at www.DiabetesTrialNet.org/locations

New! Online Screening OpportunitiesFamily members may now

conveniently participate in free screening online. After completing a consent form online, a kit will be sent to the family member’s home. This kit can be taken to any Quest lab to facilitate the blood draw needed to screen for autoantibodies.

NonprofitOrganizationU.S. Postage

PAIdSan Diego, CAPermit No 1

TCOYD is a not-for-profit 501(c)3 charitable educational organization.

For schedules, bios, trailers and more, visit www.tcoyd.org

Taking Control Of Your diabetes1110 Camino Del Mar, Suite “B”Del Mar, CA 92014 | www.tcoyd.org

Tel: (800) 998-2693 (858) 755-5683 Fax: (858) 755-6854

TCOYd Conferences & Health Fairs 2014 Schedule

February8 NativeAmerican, Pala,California March8 Sacramento,California April12 Honolulu,Hawaii May17 Raleigh,NorthCarolina June7 Washington,DC September6 Missoula,Montana September27 DesMoines,Iowa October18 Amarillo,Texas November8 SanDiego,California

12 My TCOYD Newsletter, Vol. 45

See Table 1 for tips to prevent yeast infections. Be sure to contact your medical provider should you experience genital itching, redness, or skin flaking, since you will need treatment with an anti-fungal agent. Similar to blood pressure medications, Invokana can cause dizziness and lightheadedness due to the reduced blood pressure effect it has. This might be an important consideration for senior patients who already have adequate blood pressure control. Finally, those

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Urinating down Your A1C

with very high levels of cholesterol should note that Invokana has been shown to increase both your LDL (bad cholesterol) and HDL (good cholesterol).

Bottom LineInvokana is a great new drug

for those with type 2 diabetes and shows much promise. By allowing urination of excess glucose, it provides a three-prong attack on the important health concerns of most diabetic patients. This includes

lowering blood glucose, weight, and blood pressure. While it’s not a cure for diabetes, when coupled with a healthy diet and exercise, Invokana appears to provide a formidable new weapon in the fight against diabetes.

Submitted by:Candis M. Morello, PharmD, CDE, FASHP; Associate Professor of Clinical Pharmacy and Associate Dean for Student Affairs at UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences and Clinical Pharmacist at VASDHS

Tiep Ly, 3rd Year Student Pharmacist at UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences.