Breaking Diabetes News: New Drug Reduces CV Death

EMPA-REG OUTCOME is a new cardiovascular-safety trial for a Type 2 Diabetes medication which is on the market under the name Jardiance (empagliflozin).

Approximately half of all deaths in people with Type 2 Diabetes are caused by heart disease.  So focusing on heart health and Diabetes is at the center of Research and the results of this class of drug (SGLT-2 inhibitor) reveal very exciting news. Previously many trials with this medication have shown cardiovascular safety, but for the first time a Study has shown that this medication actually cuts cardiovascular deaths.

This particular Study focused on high risk cardiovascular patients with Type 2 Diabetes.  It was seen that not only CV deaths were reduced, but over all deaths were lower in the group being treated with empagliflozin than those who were on a placebo (an inactive substance used to measure the control group).

There are theories as to why this occurs, but the mechanism remains unknown.  It could possibly be that the medication is treating mild heart failure, or preventing it from developing which could be preventing these high cardiac risk patients from suddenly dying, according to Dr. Inzucchi, the senior author on the trial. More research will need to be conducted.

Dr Pfeffer is an expert in heart failure.  He was lead author on the ELIXA trial and he said he never tries to determine mechanisms from studies such as EMPA-REG but stressed that empagliflozin “is clearly showing benefit.”

The full article on this Study is certainly worth the read.  This is an exciting time for Diabetes Research! Visit Medscape Here to Read the Full Article.


If you would like to participate in Clinical Research visit  We have done many Studies with empagliflozin in the past and could potentially be conducting more for Type 1 and Type 2 Diabetes!

World COPD Day

Twitter is a buzz with #WorldCOPDDay and several medical and pharmaceutical companies are finding innovative ways to bring awareness to this crippling disease. One of my personal favorites is the  “Make Twitter #COUGH” campaign, put on by Boehringer Ingelheim.

Today, on World COPD Day 2015, Boehringer Ingelheim is making Twitter #COUGH to raise awareness of this chronic lung disease.

As the world #COUGHs to raise awareness of COPD (chronic obstructive pulmonary disease), the hashtag will produce a noisy spike in tweets, simulating the sound wave of a COPD sufferer’s chronic cough – a key symptom of the disease.

“Boehringer Ingelheim is calling on Twitter users to help raise awareness of COPD.” said Professor Klaus Dugi, Medical Director and Managing Director UK & Ireland, Boehringer Ingelheim “We want to highlight the importance of supporting people living with this life-changing condition while also addressing and tackling the problem of late diagnosis and misdiagnosis, which can impact life expectancy and dramatically affect the quality of life of people affected by COPD.”

Here at Sestron Clinical Research, we are participating in the global initiative to help bring new COPD medications to market.

COPD is the third leading cause of death in the United States. More than 11 million people have been diagnosed with COPD, but an estimated 24 million may have the disease without even knowing it. COPD causes serious long-term disability and early death. At this time there is no cure, and the number of people dying from COPD is growing.

Help us bring awareness about this smoking related illness and help America breathe better. Tweet #WorldCOPDDay November 18th, 2015.

Global Site Solutions Summit

This past weekend the Global Site Solutions Summit was held in Amelia Island, FL.

This event included attendees from Clinical Research Sites, Sponsors, CRO’s, IRB’s and even presence from the FDA.  The entire gamut of alphabet soup! The collaboration of partners was truly exciting to witness. Topics of break-out sessions ranged from “preparing for an FDA audit” to “reducing the number of screen fails”. There was a record number of people interested in the new “Common Rule”, which will affect all of us involved in conducting clinical trials.  The streamlining process has begun with Christie advocating for us, the Sites.

A big Thank You to all who attended the event and made it such a raving success. See you all next year!


Visit The Society of Clinical Research Sites for all of the information. Don’t forget to check out @SestronResearch on Twitter and see the photos from the Conference and Gala.  Did I mention, the food was the best I’ve had yet? And there may even be some “selfies”!

Glucose Logs on your iPhone? It’s Here!

With a growing demand for streamlining technology and the record breaking use of cell phones being substituted for PC’s, this is a moment Diabetics have all been waiting for!

Are you sick and tired of juggling multiple devices such as lancets and glucometers?  Are you over lugging around multiple devices, just to monitor your blood glucose? Would you give anything not to have to stick your finger multiple times a day? Your wish may have come true.

Diabetics rejoice! There is a new CGM (continuous glucose monitor), the Dexcom G5 mobile CGM, which has just been approved by the FDA on August 25th.  It has Bluetooth capabilities built right into it and transmits data to an app on iOS enabled smart phones.  It has been FDA approved for people as young as 2 years of age! This app can be synced with as many as 5 devices. That means parents and caregivers can stay up to date with their loved ones blood glucose levels in a convenient and streamlined way.

All of your glucose logs kept conveniently on you phone. Incredible!

If you don’t have an iPhone, don’t worry! Android is expecting to release their app at the beginning of the year.

To read the article on Medscape Click Here

High Cholesterol: Who’s at risk?

Sestron Clinical Research is beginning a Study on a new medication to lower cholesterol.  In light of this news, I wanted to share with you some risk factors, and how to determine your risk factors.

High Cholesterol in the United States

  1. 73.5 million adults (31.7%) in the United States have high low-density lipoprotein (LDL) also known as bad cholesterol.
  2. Fewer than 1 out of every 3 adults (29.5%) with high LDL cholesterol has the condition under control.2
  3. Less than half (48.1%) of adults with high LDL cholesterol are getting treatment to lower their levels.1
  4. People with high total cholesterol have approximately twice the risk for heart disease as people with ideal levels.
  5. Nearly 31 million adult Americans have a total cholesterol level greater than 240 mg/dL


What is cholesterol? Cholesterol helps you digest foods and build cell membranes. Your liver actually makes all the cholesterol that your body needs. Too much of it can put you at risk for heart disease and clog your arteries.

Are you at risk? One in 6 adult American’s have high cholesterol. Even children can have it.  Age, sex, and heredity are not factors that you can change, but there are risk factors that you can control.  Living a physically inactive lifestyle, being overweight, smoking, and eating unhealthy food- these are things you can change!

But I don’t have any Symptoms: Most people with high cholesterol do not have any symptoms.

How can I calculate my risk?

Step1: In order to analyze your risk, you will need to schedule an appointment with your Dr. for a simple blood test. They will look at you LDL (bad cholesterol), HDL (good cholesterol), Triglycerides, and Total cholesterol.

LDL should be under 100, HDL 40-59, and Total Cholesterol less than 200.

If this is you: Go celebrate your health!

If not, it’s okay.  You can get there!

Step 2: Identify the presence of factors that increase the risk of Coronary Heart Disease (CHD): Clinically diagnosed CHD, Symptomatic coronary arterial disease, Peripheral arterial disease, Abdominal aortic aneurysm

Step 3: Determine the presence of major risk factors: smoking, high blood pressure (greater than 140/90), Low HDL (less that 40), Family history of CHD, women over 55 and men over 45 yrs of age.

Step 4: If you have 2 or more risk factors, you may be in need of more than just lifestyle changes and require a medication to lower your risk.  It would be a good idea to see your Doctor.

Step 5: determine your goal!

Would you like to lower your risk? The Therapeutic Lifestyle Changes (TLC) feature:

  • Diet: Saturated fat <7% of calories, cholesterol <200mg/day
  • Increasing fiber (10-25) g/day) and plant stanols/sterols (Click Here for diet suggestions)
  • weight management – (Click here)
  • Physical Activity- we suggest starting by walking out your front door and picking a direction (right or left) and walking 10 min out and 10 min back, at least 3 times a week.  Then you can build up to the CDC’s recommendations for 2 hours and 30 min each week. (Click Here for the CDC recommendations)

It’s so simple! It takes 28 days to develop a habit. I challenge you – Try it for 28 days – then let me know about your successful new habit!

COPD… What is it and could you have it?

24 million Americans have COPD, but 12 million do not know that they have it. Are you one of the missing millions?

Sestron Clinical Research is currently conducting a trial for people with moderate to severe COPD.  I thought this would be the perfect opportunity to bring some awareness to this subject.

COPD– stands for Chronic Obstructive Pulmonary Disease. It is a disease that progressively gets worse over time, making it difficult to breathe. It can cause coughing that produces mucus, wheezing, shortness of breath, chest tightness, and other symptoms.

Smoking cigarettes is the leading cause of COPD. Other irritants such as air pollution, chemical fumes, or dust may also contribute to COPD.

Early detection is the key with this type of disease, since quitting smoking can greatly help reduce the problems associated with COPD.  Stress is another trigger that has been found to worsen the symptoms of COPDStress management skills are a great tool to help both your mind and body relax .

Below I am providing a personal story of a woman with COPD

When I quit smoking back on Jan. 16, 2005, I was using oxygen 24/7. I needed to take breathing treatments every four hours and was watching the clock for the next treatment. I was on 20 different medications, and up until five years prior, I had smoked two packs of cigarettes a day for 40 years. I coughed constantly and had a magnificent wheeze going most of the time. I was only 57 years old.

Before I quit, my smoker’s cough was diagnosed as stage III COPD (there are four stages). COPD covers conditions such as emphysema and chronic bronchitis. It is a progressive condition and will never go away once you have it.

I couldn’t walk to the mailbox. When I went to the market or Target or Walmart, I had to use one of those motorized carts. I couldn’t even unload all the groceries when I got home, only the perishables.

And then I quit smoking and immediately expected all these wonderful improvements. But it didn’t happen. I became frustrated, but I still kept at it.

Three months after I quit, I became ill with a lung infection that was resistant to several antibiotics. It took more than five months and three hospitalizations to get rid of it.

To be honest, if I had been smoking, I doubt that I would have survived the infection. During one of those hospital visits, I was also diagnosed with the beginning of congestive heart failure (CHF) and told that it was caused by my lung disease. Apparently, they go hand in hand. (Since that time, I have seen a cardiologist and I no longer have CHF).

Truthfully, I thought I was going to die soon and I had my lawyer draw up my living trust and will. I even wrote out what songs I wanted played at my memorial service. I had some heart-to-heart talks with my wonderful family, too. They were so afraid that they were going to lose me. I wasn’t depressed or morbid. I’m just one of those people who function better if I’ve got things arranged and organized. It gave me peace of mind.

And then, I decided to control this condition instead of having it control me!

I found a new personal doctor and a new lung doctor. I asked the doctor to cut out some of my medications and he cut them down to only nine — from 20.

And I didn’t smoke!

I researched heart disease on the Internet and signed up for the American Heart Association newsletter. I also subscribe to the American Lung Association newsletter. I began eating a heart-healthy diet and started a pulmonary rehabilitation class at my local hospital.

And I don’t smoke!

My lung volume (FEV1) has increased from 38 percent to 43 percent of the normal predicted value. At pulmonary rehab, I was able to exercise at a steady pace for 12 continuous minutes without a drop in my oxygen and I needed no supplementaloxygen. I no longer need any supplemental oxygen.

And I can walk to the mailbox again and shop without the motorized carts!

I can sing again! And I love to whistle! I can sing again! And I love to whistle!

And I don’t smoke!

I may not be able to ever get rid of this disease — but trust me, I’ve sure slowed it down. I plan to live every day of my life now!

I just hope that those of you who are struggling or playing around with quitting will finally realize that smoking is doing nothing but killing you, cell by cell. I hope you quit before you get sick with cancer or heart disease or lung disease.

All you have is now. It will determine tomorrow.

By “GrammaCC” | Medically reviewed by Kevin O. Hwang, MD, MPH

Read the article on: EveryDayHealth

You can see why early detection is so important!

Please take this 5 question risk screener — it takes less than a minute to find out if you are at risk for COPD. – at:

Millions have Diabetes and don’t even know it!

Everyone has to eat, right?  But did you know that most of the food you eat is turned into glucose?  Glucose is basically sugar, and that is what our body uses for energy.  The pancreas is an organ, located near your stomach, which makes a hormone called insulin.  Insulin helps the glucose enter into our cells- where it can be used by the body.  Diabetes is a disease in which blood glucose levels are above normal. When you have diabetes you have one of two issues:

1. Your body doesn’t produce enough insulin.

2. Your body can’t use the insulin it does produce the way it should.

When this happens the sugar builds up in your blood.

Diabetes can cause serious health complications including heart disease, blindness, kidney failure, and lower-extremity amputations.  Diabetes is the seventh leading cause of death in the United States.

Diagnosed and undiagnosed diabetes in the United States. Total: 29.1 million people or 9.3% of the population have diabetes. Undiagnosed: 8.1 million people (27.8% of people with diabetes are undiagnosed)

It is very important to know what your A1c is and to live a healthy lifestyle! Your Dr. can check your A1c with a simple blood test.  If you  live in GA, Sestron Clinical Research can help.

Visit the CDC website for more information!

Tim McGraw weighs in on Diabetes

Did you know 29.1 million people in the U.S. have diabetes?  8.1 million of those may be undiagnosed or unaware of their condition.  According to the American Diabetes Association 33% of those with type 2 diabetes have not reached their target A1C goals.  That means a staggering 7 million people are at a higher risk of many diseases due to high blood glucose, low blood glucose, or swinging between both.

Here at Sestron Clinical Research we provide an opportunity to connect with our doctors, receive diet and exercise counseling, and participate in Clinical Trials for Type 1 and Type 2 diabetes.  You may be wondering why we list participating in a Clinical Trial as a way help someone reach their target A1C goals.

Did you know that most diabetics who participate in a Clinical Trial have a better chance of reaching their target A1C? Research Site’s often have a better ability to provide one-on-one time to get to know you and help you overcome the hurdles you face as an individual with certain lifestyle challenges.  If you live in the Atlanta, GA area we can help. Visit our website

If you are in the Peach State: Tim McGraw is coming to Atlanta in November for the Kicks Country Fair!

Even if you are not in the Peach State, keep reading!

Why do we care about Tim McGraw (besides the fact that he is a great country artist)?

Merck and the ADA have teamed up with Tim McGraw.  They are running the American’s Diabetes Challenge: “Get to Your Goals” to help people with diabetes work with their doctor to get to their A1C goal.

If you have diabetes, take the challenge. Pledge to work with your doctor to set and reach your own A1C goal. Also, be sure to learn if you are at risk of low blood glucose, known as hypoglycemia, and how to help reduce that risk. Friends and caregivers are encouraged to challenge their loved ones to take the pledge and help support the millions of Americans living with this disease.

The American Diabetes Association recommends that people with diabetes have an individualized A1C goal. The goal for many adults with diabetes is less than 7 percent. A higher or lower goal may be appropriate for some people. You should speak with your doctor about what goal is right for you.

Did you know that diabetes disproportionately affects different ethnic groups?

  • 13.2% of all African-American adults live with diabetes
  • 12.8% of all Hispanic adults live with diabetes

“I’ve seen first-hand how type 2 diabetes impacts Americans from all walks of life. It’s affected my family, friends and fans. I’m a strong believer in making healthy choices, so I’m encouraging all Americans to join me and challenge their family and friends with diabetes to work with their doctor to get to their A1C goal. Together, we can make a difference.” – Tim McGraw

Talk to Your Doctor to Know Your A1C

Before your appointment, prepare yourself: Be prepared to talk about how your treatment plan is working for you. Be prepared to set an A1C goal. Your doctor will help set your goal that is right for you. Here are some important questions to address with your doctor.

  • What is my A1C and what should my goal be?
  • What are the signs and symptoms of high and low blood glucose?
  • Do I need to make any changes to my diabetes management plan?
  • What are the benefits and possible side effects of the medicine(s) I’m taking?
  • What are the possible causes of high and low blood glucose?

American Diabetes Association. “American’s Diabetes Challenge.” Diabetes. ADA, 1 Apr. 2015. Web. 15 July 2015.

Accept America’s Diabetes Challenge


Do you have questions about Diabetes, Clinical Research, or anything else that we have discussed on our blog?

Leave a comment below!  Other readers and/or our staff may be able to help.

For Diabetes friendly recipes, visit our Facebook Page! CLICK HERE

Diabetes and Alzheimer’s Disease: Could there be a link?

We know that diabetes care has been improving and patients with diabetes are living longer.  In turn, Doctor’s have an older patient population to observe.  Sestron Research recently discovered that leading Doctors around the country have noticed a high percentage of Type 1 and Type 2 diabetics with Alzheimer’s Disease.   Have you ever forgotten where you put your keys? Or wondered if you’ve lost your mind, until you discover your glasses on top of you head? Did you notice a little voice in your head asking “Could this be Alzheimer’s?”.  This is certainly a natural fear, since no one wants to lose their independence.  But if you are a diabetic, or someone you know and love has diabetes, you may want to read this article from Medscape.

Type 1 Diabetes Linked to Increased Dementia Risk

Pauline Anderson

July 23, 2015

WASHINGTON, DC — Older patients with type 1 diabetes (T1D) have more than an 80% increased risk for dementia compared with those without diabetes, a new study suggests.

Previous research showed that older people with type 2 diabetes (T2D) have about a two-fold greater risk for dementia compared with people without diabetes, but the current study is the first to look at dementia risk in elderly adults with T1D.

“There has been a paucity of work in type 1 diabetes because only recently have they been living longer, and living long enough to be at risk for an age-related neurocognitive dysfunction,” Rachel Whitmer, PhD, senior scientist, Division of Research, Kaiser Permanente, Oakland, California, told Medscape Medical News.

Dr Whitmer presented the results here at the Alzheimer’s Association International Conference (AAIC) 2015.

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Landmarks in Diabetes: 1995 to 2015

Welcome to the first blog post of Sestron’s Clinical Research News Room.  We are very excited to begin sharing some great resources for information on Clinical Research with you.  We will also share related materials regarding medical advances in the treatment of many diseases we are conducting Clinical Trials on here in Marietta, GA.  The first article I would like to share comes from Medscape.  It covers the some of the greatest game changers in diabetes over the past 20 years.

At Sestron we are conducting clinical trials using the newest medications for the treatment and maintenance of Type 1 and Type 2 Diabetes.  We hope these medications will make the list for “Landmarks in Diabetes” for the 21st century.

Visit our website: to see what trials are currently available to you for participation.

Read Medscape’s Article below!

Editor’s Note: To commemorate Medscape’s 20th anniversary, they asked several experts to describe how the management of diabetes has evolved over the past 20 years.

The discovery of insulin in 1921 and the availability of home blood glucose monitoring in 1981 perhaps represent the greatest advances thus far in the world of diabetes. But in the past 20 years, numerous incremental developments have also remarkably improved the prognosis and quality of life for patients with both type 1 and type 2 diabetes.

“Twenty years ago, every minute of every day there were patients in my lobby with below-the-knee amputations, seeing-eye dogs, or white canes. Today this is so rare, I am convinced that we are only beginning to understand what the natural history of diabetes will be in the 21st century,” says John Buse, MD, PhD, professor of medicine, dean for clinical research, and chief of the Division of Endocrinology at the University of North Carolina School of Medicine, Chapel Hill. In contrast, he says, “The prognosis for a normal lifespan free of disabling complications, I think, is excellent for people living with diabetes today.”

Of course, progress is often cumulative, and the advances over the past 20 years were built on earlier progress, such as the 1993 landmark Diabetes Control and Complications Trial and the Lower Extremity Amputation Prevention (LEAP) program. The former study found that maintaining blood glucose levels as close to normal as possible slowed the organ damage that often occurs in diabetes. The latter study established the use of the monofilament as an easy, in-office test for foot sensation, notes Charles Clark, MD, professor emeritus of medicine and now associate dean for continuing medical education at the Indiana University School of Medicine.

Looking back over the past 20 years, five particular advances stand out for their role in improving the lives of people with diabetes.

Metformin: The Game Changer

In the United States, 2015 marks the 20-year anniversary of the arrival of the first oral medication for type 2 diabetes that does not cause hypoglycemia. Metformin had been available outside the United States for over a decade, but its approval here was delayed while the US Food and Drug Administration (FDA) focused on removing a related but more toxic compound, phenformin, from the market.

Today, metformin still is used as first-line therapy for type 2 diabetes, owing to its relative efficacy, safety, and low price as a generic.

Add-on glucose-lowering medications offer the advantages of weight loss and improved blood pressure levels. In 2005, the FDA approved the first glucagon-like peptide 1 receptor agonist (exenatide), followed in 2006 by the first dipeptidyl peptidase 4 inhibitor (sitagliptin); the first sodium/glucose cotransporter 2 inhibitor (canagliflozin) arrived in 2013.

For type 2 diabetes, the biggest advance is “the sheer number of effective drugs that have been developed within the past 15 years,” says Cyrus Desouza, MBBS, professor and chief of the Division of Diabetes, Endocrinology and Metabolism at the University of Nebraska Medical Center. “Physicians treating type 2 diabetes have never had so many choices and combinations as now,” he continues. “From a patient’s perspective, this has led to better diabetes control and hence decreased microvascular complications.”

Still, lingering long-term safety questions, the high cost, and the moderate (at best) ability of these agents to lower blood glucose mean that there is plenty of room for further innovation in the years to come.

As Dr. Clark sees it, “Once you had metformin, everything else was incremental. Metformin was the game changer.”

Glucose Monitoring and Insulin Pumps

Continuous glucose monitoring (CGM) has revolutionized the care of type 1 diabetes, and it has also allowed for better troubleshooting in some patients with type 2 diabetes. CGM can provide information on daily glucose fluctuations and how those numbers are affected by everyday activities and stress levels. It also plays an integral part in emerging technology billed as an “artificial pancreas,” partnering with continuous sensing technology to form a closed-loop glycemic control system that includes an insulin pump and controlling algorithms.

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