Coconut Butter: Health Hoax or Health Miracle?

By Rob Leighton - Share your opinion!

Extra virgin coconut butter – it’s one of the trendier nutritional ingredients. Coconut oil is advanced for its ability deliver fast energy without affecting blood sugar. Its use is touted as a way to speed up the metabolism making weight loss easier. It is being sold as essential oil for addressing certain forms of cognitive decline and dementia.
Coconut oil also is a saturated fat that does cause an increase in cholesterol levels. For 4-6 hours after a meal, it also has been shown to hinder our arteries’ ability to relax and dilate. It may contribute to insulin insensitivity, and – despite the antioxidant levels of extra virgin coconut oil – is likely somewhat inflammatory.
Health aside, extra virgin coconut oil/butter is a great for baking! Flaky and crusty cakes, pies and other baked goods without out the animal products.

The good, the bad, and the delicious.

We have long known that some fats are healthier and some are harmful—with saturated fats (SFAs) generally falling into the harmful category. Coconut butter is substantially a saturated fat, but……
….The saturated fat in coconut is different from that of most other fats and oils, not only saturated kinds, but also the polyunsaturated and monounsaturated fats. While most dietary fats are composed of long-chain fatty acids, coconut butter is composed largely of lauric acid, a medium-chain fatty acid.
Without going into the chemistry, the key point to understand is that lauric acid can be absorbed directly into the body and even directly into the cells, undigested. Other fats and oils must first be broken down. The lauric acid thus can serve as quick, no-sugar source of energy.
For some time, coconut oil has been known to be a useful source of energy for selected groups. Coconut butter has been shown beneficial for infants, individuals with difficulty digesting fats, and possibly for athletes requiring a quick burst of energy.

And Cholesterol

Coconut oil, like other saturated fats and trans fats, does increase cholesterol levels.
Adding 10 percent or 20 percent coconut oil in the diet for one to two weeks increased cholesterol levels, including LDL cholesterol levels, as well as total triglycerides in the blood.[i]
In India, coconut butter has been used widely by much of the population. Heart disease in India is among the highest in the world. Indian researchers sought to determine the effects of blending a polyunsaturated fat (PUFA), like those found in vegetable oils, with the coconut butter. Cholesterol levels were reduced between 5 percent and 21 percent, when the amount of coconut oil was reduced by blending in PUFAs. The authors of the Indian study concluded that the atherogenic (the artery blocking build of plaque) potentials of a coconut oil can be significantly decreased by reducing this oils intake by blending it with the polyunsaturated vegetable oils.[ii]

And Arterial Dilation

Another study also found that coconut oil compromised how the arteries functioned for four to six hours after a meal when compared with polyunsaturated fats.[iii] The coconut oils adversely impacted the arteries ability to relax and dilate. These results are the similar to those found for any saturated fats

And Blood Sugar Regulation

High-fat diets, particularly those rich in SFAs, also have been shown to reduce the body’s ability to regulate blood sugars. These diets are associated with a decline in the body’s ability to use insulin effectively. One study compared three types of diets: a diet high in medium-chain fats like the lauric acid found in coconut oil, a diet high in long-chain fats, and a low-fat diet.[iv]
Both high-fat diets led to the less effective use of insulin compared to the low-fat diet. The effect, however, was less significant with the high medium-chain fats.[v], [vi]
In another study, however, only the long-chain SFAs affected insulin levels. The medium-chain fats did not.[vii]

And Weight Loss

What about increasing metabolic rate? There may be some science here – but here is the trick. Coconut oil is still high in calories. Whatever the increase metabolic rate, it will be overwhelmed by the additional calories. Cut back on another source of calories for any potential benefit. Figure a teaspoon of coconut oil is about 45 calories.

Using Coconut Butter: Summary

While the research continues, coconut butter falls somewhere between a healthful and a harmful fat. For some specific groups, though, notably infants and adults with difficulty digesting fats, coconut butter may have a very useful nutritional role. Some also suggest that coconut butter helps improve certain types of dementia, but the data again is far from conclusive.
What about the antioxidant and anti-inflammatory compounds in extra-virgin coconut oil? Personally, I see no reason to seek out a high calories source of these compounds – and the lauric fatty acid may have some inflammatory effects itself. Look to high nutrient, higher fiber vegetables, fruits, nuts, and fish for these compounds.
Looking beyond the health benefits though, coconut butter has some great culinary benefits. For the baker, coconut butter offers a somewhat better alternative to the standard dairy butter. For the vegan baker, coconut butter may be an essential ingredient for making delicious desserts.
For most of us, however, more research is needed before we take steps to add a lot more coconut butter to our diets. It may be healthier than other types of SFAs, but the evidence does not seem to suggest it would qualify as a healthy fat, and remember, even healthier fat should be used smartly.
Learn more about how you can keep you arteries young and healthy, and beat back diabetes, dementia and heart disease – and still love food every day – in the Kardea Heart Smart Solution (affiliate link).

Blood Sugar Testing 101 for Type 2 Diabetes

Blood Sugar Testing 101 for People with Type 2 Diabetes: Why, When & What to Do

By Diane Kress, RD CDE - 86 comments

The Why
I am a registered dietitian and certified diabetes educator, have run Diabetes Centers in hospitals, have a private practice in medical nutrition therapy specializing in metabolic syndrome, weight loss, and type 2 diabetes, and have written a NY Times Bestselling book on the same topics. January 10, 2012 was the world-wide release of my newest book, The Diabetes Miracle.
I have had type 2 diabetes for 15 years.
Guess what?  If you asked me what my blood sugar is right now, I have no idea.  Neither do you!

• Did you know that unless your blood sugar is over 200mg/dL, you most likely will have none of the traditional diabetes symptoms such as excessive thirst, urination, fatigue, hunger, or wounds that will not heal?
• If you’ve run blood sugar over 200mg/dL for a period of time, you probably won’t even have symptoms when your sugar exceeds that 200mg/dL point.
• If you have been prescribed medication for diabetes that is aimed at reducing your blood sugar and you begin to feel shaky, dizzy, nauseated, can’t speak clearly, can’t think, feel wiped out….you may assume that you are hypoglycemic.   Are you?  Without testing, you really have no idea…your once high readings may have returned to normal range…and your body may assume you are hypoglycemic when you are far from it!   If you grab some juice or glucose tabs, you will push that normal sugar right back into the very high range.
• Or maybe those symptoms really are hypoglycemia and if you don’t treat it, you will lose consciousness, fall down the stairs, drop your child, run off the road.
• Your Hemoglobin A1C might be 6.3 and you think to yourself:  “Wow, my blood sugar is now normal…why should I spend the money and take the time to test?”  Do you realize that hemoglobin A1C is your average blood sugar 24 hours/day, for about 3 months back in time?  An average is the average of highs and lows.  It is possible to have a 6.3 hemoglobin A1C because you are averaging normal from blood sugar readings that are in the high 200’s and in the low 50’s!
• You may be following your meal plan, exercising, are not stressed, haven’t been sick and think maybe you don’t need that medication.  Without monitoring, how can your physician make an educated decision on your medication or doses?

The When

Testing your blood sugar is a quick, not too painful, fairly accurate way to determine where your blood sugar stands at different times of the day.  Many people don’t know when they should test.   People with type 1 diabetes usually test before each meal, at bedtime, and anytime they feel low.  People with type 2 diabetes have a much different test schedule.
I can’t tell you the number of patients I’ve seen who only test first thing in the morning.  They initially come to my office with months of wake up (fasting) readings.  I scan them, see some high readings, and ask…What do you think caused your fasting reading to be so high on this morning or that one?
Invariably, the patient will “confess” one of the following scenarios:

• The night before, they went out to dinner late and ate pasta, garlic bread, and zeppoles. .
• The night before, they over-snacked watching a late night football game.
• They had a bagel for breakfast and a candy bar in the afternoon the day before.
• They had a snack right before bed

Well, here is an eye-opener.  When a person with type 2 diabetes has a high fasting blood sugar, it is not because of anything that happened dietarily the day or night before!!!!  Why?  Carbohydrate is the nutrient that converts into blood sugar and carbs have a lifespan of about 5 hours.  When more than 5 hours pass after you eat carbs, your brain sends a signal to the pancreas to release a hormone called glucagon and this hormone signals the liver to release glycogen (sugar stores) into the blood.  So…anytime you check your blood sugar and more than 5 hours has passed since you last ate, you are looking at your liver’s self feeding mechanism!
If you only test your blood sugar in the morning before you eat, you are only seeing what your liver is up to.  That reading tells you nothing about how your body is reacting to the food you ate the previous day/night.
So, how can you find out how you are handling food (specifically carbohydrates)?  You should consider testing your blood sugar 2 hours after the START of a meal.  So, if you are having dinner at 6 PM and want to assess how high your blood sugar rose from dinner, test at close to 8PM.  If you wait until bedtime at 11PM, you missed it….because you are at the 5 hour mark.  After you eat, your sugar rises for about 2 hours, then comes back to normal over the next 2 hours, then hangs tight for the last hour of the 5 hour blood sugar curve.
If I have type 2 diabetes, and I want to know how my sugar is doing at the 2 times of the day it is likely to be highest…I would check first thing in the morning before I eat (checks the liver) and 2 hours after the start of my largest meal (checks the food).

What’s Normal?

I suggest that you ask your MD or health care provider for what your target blood sugar should be.  The following are the blood sugar ranges I typically use with my patients with type 2 diabetes whether they are following diet/exercise or diet/exercise/oral meds:
Fasting:  blood sugar less than 120mg/dL  (80-120mg/dL)
2 hours after the start of a meal:  blood sugar less than 140mg/dL.  If you happen to miss the 2 hour after time and check at 3 hours it should be under 130mg/dL.  If you don’t check until 4 -5 hours after the start of a meal it should be under 120mg/dL.  You can see that the highpoint is at the 2 hour mark.
Those with type 2 diabetes taking insulin will usually test premeal and at bedtime.  Your MD will tell you your individual targets if you use insulin to control your diabetes.

What to Do with It?

I find it is helpful to write my numbers down.  I know that the meter can keep hundreds of readings in memory…and I know they are time stamped (if you bother to set the meter’s time) but for me….I like to see patterns.  Even if you only use a sheet of paper…you can head it like this and mark or circle your readings that are out of zone.  Then, try to come up with a reason.
Chart for those in the USA using mg/dl 

Fasting	After Breakfast	After Lunch	After Dinner	Reason
110	2 hrs = 126
107		2 hrs = 157		had a bagel
140			2 hrs 122	didn’t sleep well
152	3 hrs = 120			poor sleep
139			2 hrs 109	poor sleep

Chart for the rest of the world in mmol/L

Fasting	After Breakfast	After Lunch	After Dinner	Reason
6.1	2 hrs = 7
6.0		2 hrs = 8.7		had a bagel
7.8			2 hrs 6.8	didn’t sleep well
8.4	3 hrs = 6.6			poor sleep
7.7			2 hrs 6.0	poor sleep

By highlighting any numbers that are out of range and trying to come up with a reason for the reading, I can see that my sleep difficulties are really affecting my blood sugar and may need to address this with my MD if the situation does not improve.   Why would my fasting reading be elevated?

• Poor sleep
• Pain
• Infection or Illness
• Not eating a night snack (liver is “on” longer)
• No exercise previous evening (muscles “consume” blood sugar for hours after exercise ends)
• Forgot to take my Metformin at bedtime
• Right before menstrual period
• Stress out

Why would my post meal readings be elevated?

• Forgot my medication today
• Pain
• Illness or infection
• Overeating carbs at the meal I’m checking
• No exercise earlier in the day
• Right before menstrual period
• Taking steroid based medication (prednisone/cortisone)
• High stress day

What about low blood sugar?

Blood sugar under 70mg/dL, when taking diabetes medication (orals or insulin) is considered to be hypoglycemia and needs to be treated as directed by your physician.  The standard treatment is a quick source of carb like 3-4 glucose tabs, ½ cup juice, ½ can regular soda (6 ounces), 8 ounces nonfat milk,, etc.  After waiting 10 minutes, retest your blood sugar and make sure it is over 80.  If it remains under 80 after the treatment, repeat and retest in 15 minutes ascertaining that does, indeed, rise over 80.  Report repeated hypoglycemia (not an isolated event) to your physician as you may require a medication or dosage change.
Diane Kress is the author of the New York Times Bestseller; The Metabolism Miracle and it’s companion book, The Metabolism Miracle Cookbook.  She just released her breakthrough book on preventing and controlling type 2 diabetes: The Diabetes Miracle.  Read more about her program at www.thediabetesmiracle.com.

TOP 7 DIABETES RESOURCES

Of the 26 million Americans with diabetes, more than half are currently not meeting medical targets established by the American Diabetes Association.  Another 79 million Americans are at risk for developing diabetes.  Odds are, diabetes impacts your life or someone close to you.  The good news: with the right knowledge and support, people with diabetes can feel good and live strong, healthy lives.

David Edelman, co-founder and president of DiabetesDaily.com – an online community for people with diabetes – receives queries daily from people with diabetes and their family members searching for the best resources to help them make decisions.

“We get this same short, frustrated email nearly every day: I was just diagnosed with diabetes.  What should I do?” said Edelman.  “Every time we respond, we think to ourselves this question is so big it deserves a better answer.”

In honor of American Diabetes Month, Edelman has identified the top seven most useful resources to arm people with diabetes – and those who support them – with the knowledge they need.

1. Personal Support Network: It is critical to build a strong network of family, friends, and other people living with diabetes. Diabetes is an emotional marathon and the support and understanding from those that care help you move forward with your head up. Whether you communicate through email or meet in person, stay connected with your network, share your struggles and triumphs.

Know someone with diabetes? Be an essential support tool for him or her.

2. The Diabetes Online Community: People with diabetes have built an international support network through blogs, online support communities like DiabetesDaily.com, diabetes social networking sites like TuDiabetes, and through traditional social media channels like Facebook and Twitter.  These online resources offer the chance to connect emotionally and seek advice and information from others living with diabetes- from the newly diagnosed to those who have been managing the disease for decades.

There are multiple ways to connect, from skimming message boards to leaving comments for or emailing bloggers to joining a community. You can even starting your own blog. Whether you or someone you love has diabetes, these online tools grant instant access to thousands of lifetimes worth of wisdom.

3. Formal Diabetes Education: A diabetes educator can help you understand why blood sugars change and what you can do to manage those changes. Patients with Medicare can access 10 free hours of diabetes educations per year (the average patients uses less than three). Most private plans cover education as well. Your doctor or local diabetes association can help connect you with a good educator.  However, the unfortunate reality is there is just one diabetes educator for every 2,630 people with diabetes.  To maintain and enhance education between visits with your educator, consider attending local support groups or workshops (often hosted by hospitals or health networks).

For diabetes patients and family and friends trying to better understand its impact, books can help you better understand diabetes, like “50 Diabetes Myths That Can Ruin Your Life and the 50 Diabetes Truths That Can Save It” by Riva Greenberg.  Or consider an online education course like “Workshop for Better Blood Sugars” from Diabetes Daily University (http://university.diabetesdaily.com), which allows you to learn at your own pace and connect with others in a virtual classroom.  Make sure that educational courses are taught by a credentialed and nationally recognized physician or educator.

4.  Meal Planning Tools: Want the “Approved Foods List” for people with diabetes? You are out of luck: it does not exist! People with diabetes must watch how many total carbohydrates they eat, not ban specific foods. Even high carb items can be enjoyed in smaller quantities.

But to get the maximum health and enjoyment out of your diet, it helps to discover new lower carbohydrate meals or variations on your favorites. DiabetesDaily.com has an entire section of original recipes from co-founder, CEO, type-1, and foodie, Elizabeth Zabell Edelman and The American Diabetes Association has excellent recipes on its website as well.

You can track the carbohydrates in your food using tools like CalorieKing, which provides software with a detailed food database as well as the popular Calorie Fat & Carbohydrate Counter book to accurately track carbs and calories.

5.  The Meter: Blood glucose meters are the key to discovering how to live a healthy life with diabetes. Want to know if your breakfast is okay to eat? Check your blood sugars, eat breakfast, and check it again two hours later. If you are back about where you started, then this meal works for you. If not, then consult with your doctor or educator about adjusting medication or the content of that meal. Most people find that little tweaks have a big impact on their health and how they feel. Having a better understanding of how certain foods or activities impact your blood sugar makes it simpler to adjust when you choose to vary your routine. And this is all information you can get right from your meter.

For friends and family members, learn how to interpret blood sugar readings and the impact certain foods have on your friend or family member so you can better support individual choices – like having ice cream for dessert.  Often, concern can come across as judgment when well-wishers are uninformed.

6.  Exercise Specialists/Instructors: A good fitness instructor can provide information and exercises not only to help control weight, but also that specifically benefits diabetes management. For example, Diabetes Daily co-founder and certified yoga teacher Elizabeth Zabell Edelman recommends certain yoga poses to stimulate the pancreas, liver and kidneys.  Try taking a class or enlisting a buddy for group support.

7. Yourself: Edelman believes the key to successful diabetes management is taking ownership of diabetes.  You spend less that 1 percent of your year at the doctor’s office. The rest of the time you are on your own. So take the time to examine choices, actions and emotions objectively, without assigning guilt or blame.  Understand what is working for you and what is not. And if you do not understand something, do not leave your doctor’s office until you do. It is your life, and it is worth fighting for.

About Diabetes Daily
Founded by Elizabeth Zabell Edelman and David Edelman, Diabetes Daily is a leading online support network that helps people affected by diabetes live a better life.  The online support network features one of the largest diabetes forums, as well as original recipes, meal plans, cookbooks, blogs, educational resources, online blood glucose tracking, health challenges and diabetes related news.  Diabetes Daily’s mission is to connect people with diabetes, facilitate education and promote advocacy.  Since its inception in 2005, the support network has grown to include 60,000 members and 3 million annual visitors.  In 2011, the network launched Diabetes Daily University (DDU) to provide tools, information, courses and personal coaching from global leaders in diabetes education. Consumers can join the network by visiting www.DiabetesDaily.com or register for Diabetes Daily University at http://university.diabetesdaily.com.What is an HbA1c? What's a good number?Tuesday, November 08, 2011 5:07 PM[caption id="attachment_9149" align="alignright" width="300" caption="This Is Hemoglobin! Source: Wikiped"]
[/caption]

If you have diabetes, you should be tracking your HbA1c. It's the best measure that we have of your average blood sugars over the last three months.

But what is an HbA1c?!

Hemoglobin is the stuff that carries oxygen in your blood and gives it that red color. When you have extra sugar in your blood, some of it attaches to the homoglobin and forms a variant called hemoglobin A1c. It's also called "glycated hemoglobin" - or HbA1c for short.

Hemoglobin and its variations live for about 120 days. By measuring the percentage of HbA1c in your blood, we can tell about how high your blood sugars have been during that lifespan.

How is an HbA1c test performed?

The HbA1c test is done by drawing blood from a vein. You may feel a slight pinch when the needle in inserted. Blood can be sent away to a lab or measured on a machine in your doctor's office or at a hospital.

There are home HbA1c test kits available that cost about $15 per test. The home tests are less accurate but can give you a strong estimate.

What is a normal HbA1c?

In people without diabetes, the HbA1c is usually between 4% and 6%. From the Wikipedia page on glycated hemoglobin, here's a chart showing how your HbA1c compares to your estimated average blood glucose during the prior months:



HbA1c
eAG (estimated average glucose)


(%)
(mmol/mol)
(mmol/L)
(mg/dL)


5
31
5.4 (4.2–6.7)
97 (76–120)


6
42
7.0 (5.5–8.5)
126 (100–152)


7
53
8.6 (6.8–10.3)
154 (123–185)


8
64
10.2 (8.1–12.1)
183 (147–217)


9
75
11.8 (9.4–13.9)
212 (170–249)


10
86
13.4 (10.7–15.7)
240 (193–282)


11
97
14.9 (12.0–17.5)
269 (217–314)


12
108
16.5 (13.3–19.3)
298 (240–347




What is a good HbA1c?

Below are the 2011 guidelines for the major American standards bodies:

    American Diabetes Association - recommends an HbA1c under 7%.
    American Association of Clinical Endocrinologists - recommends an HbA1c under 6.5%.

The guidelines are based in part on the two largest studies of people with diabetes, the Diabetes Control and Complications Trial (DCCT) and its follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study. The studies found that there is a dramatic decrease in complications as HbA1cs dropped to 7% and below.

When a higher HbA1c may be recommended

Doctors do not always recommend aiming for an HbA1c below 7%. Intensive diabetes treatments can dramatically increase the risk of low blood sugars, especially if you have certain medical conditions. So if the risk of low blood sugars is very high, your doctor may recommend slightly higher targets. Likewise, if you are diagnosed when older, say in your 80s, your doctor may set higher targets because you are highly unlikely to live long enough to experience substantial complications.

Aiming for a higher HbA1c is not ideal if you will live long enough to experience complications. Because diabetes is progressive, studies have show that even a few years at a lower HbA1c has benefits decades from now.Sugar Hangover: A Diabetic Post-Halloween [COMIC]Tuesday, November 08, 2011 6:30 AMNow that I've emerged from Halloween alive and healthy, I feel this holiday deserves some reflection on strategy (hey, every year it's kind of a toss up as to the survival of sugar binge. I'm pretty sure the Keebler elves are out to get me). Like clockwork, every Halloween since I was six years old has been met with an onslaught of pity from the regular sugary folk out there.

"Poor dear, you can't enjoy Halloween like a normal kid." (Aka: you can't gorge yourself silly on sugar mini choco bars of heaven and wake up the next morning in a pile of empty wrappers and your own drool while stray raccoons poke you).

My initial urge was always to jump up and down and shriek like a demented leprechaun: I am too a normal kid! I eat candy for Halloween! My dad will beat you up if you don't give me candy! [NOTE: while my dad was never one for candy-related fisticuffs, I feel confident that he would have totally thrown a few punches for a mini-O'Henry.]

This policy shifted subtly as I grew older. It became apparent that when a trick-or-treat stash dwindled overnight, or (let's be honest) flat-out disappeared into ooey-gooey yumness in my belly, the last person accused was the sad little Diabetic girl in the corner making puppy dog eyes at her box of raisins. Before you chase me with pitchforks for this "alleged" choco-cide, let me just say that this evil stage of adolescence did not last long. It only takes one time getting caught before you become the go-to suspect for chocolate disappearances.

I shifted to my current model of Halloween celebration. It starts with good intentions, trying to look down my nose at the people around me partaking in an all-around sugar orgy as I try to valiantly convince myself as I eat my salad that yes, I am a fun person. Then comes the roller coaster ride of the sugar high, the sugar crash, and, as I mentioned before, the raccoons. FYI: they are not as cuddly and cute as they seem.

























Be sure to come and say hello (aka: share sugary stories and possibly give me chocolatey treats) on Twitter @MeganRadford or on FacebookSugar-Free Support, an eBook for Loved OnesMonday, November 07, 2011 3:26 PMI recently interviewed Naomi Kingery, The Diabetic Diva and essential member of the diabetes online community, about her third book, Sugar Free Support.

My wife has type 1 diabetes, and I took on the role of food police in the beginning. It didn't go over well. What's the key to talking about diabetes with a loved one effectively?
Take the time to learn how your loved one with diabetes would like to be communicated with in regards to their health, especially with diet because that can be a very sensitive subject. If you knew someone was a visual learner, would you try and communicate with them through audio? The same principal is applied here. If you know your loved one with diabetes needs encouragement, support, or to be simply left alone at different times then this could change everything. You can support them all day, but if it isn’t in the way they need it or at the times they will truly take it all in, then it isn’t going to be as impactful as it can be.

Sugar-Free Support BookThat makes a lot of sense. It's so easy to see something from your perspective, but much harder to switch and look through someone else's eyes. Do you see a big mistake that potential supporters tend to make?
The biggest mistake made unknowingly by many loved ones is not accepting the fact that they truly don’t, and can’t, understand what we go through. You may see what we endure on a daily basis but there is so much more involved. So continue to strive to learn more, but more importantly communicate with us so you can try to understand what goes on beneath the surface. Accept that you won’t feel the symptoms or the needle pokes like we do, and tailor your support accordingly.

If someone with diabetes just isn't taking care of themselves, what do you do? How do you handle it?
I have met many people who take care of themselves, and many that don’t. It makes me sad but immediately prompts me to encourage them because I believe the root of not taking care of yourself is typically tied to feeling like you are out there on your own. I usually begin to share my personal story with them, and it won’t be the same as theirs but it is always good to connect with other people who understand. I then ask for them to get involved in an online community if they aren’t already, like Diabetic Rockstar or TuDiabetes because these communities show you that the struggle is real, but that we can all unite and help each other each step of the way.

Your book is packed with great advice. How will reading it change someone's life?
When I first started writing it was an outlet for me to share the things that I feel I would have greatly benefited from along my path towards accepting and embracing diabetes. Along my journey I realized that people with diabetes have support, but what about those who support us? Because of that, Sugar Free Support is my third book and this was one I wanted to focus solely towards those who support people with diabetes. Their support is vital and I feel they do not receive the recognition they deserve so I wanted to make this clear. It was also very important for me to give them the descriptions and explanations they seek on what it feels like to live with diabetes so I put it all down on paper in hopes to transform individual and family relationships. And I believe it has the potential to do so because it has had that affect on my life!

What's next on your agenda?
I am currently working towards a bachelors degree in Kinesiology and am focused on continuing to build on my career at Medtronic Diabetes. I am also currently writing my fourth and final installment of The Sugar Free Series which will share about my decade journey with diabetes as I just celebrated my 10 year anniversary on September 2!

We look forward to it! In the meantime, how can someone get a copy of this and your other books?
Learn more about my books and the work I do in the community at www.livetolovediabetes.com where you will get a direct link to purchase them.

Learn more about Naomi at www.livetolovediabetes.com or connect with her on Twitter at  @naomikingery.Big Blue Test!Wednesday, November 02, 2011 3:10 PMBoy Drums for his Big Blue TestWow I can't believe that it's November already... you know what that means! It's Diabetes Awareness Month! Let's get our advocacy on!

The wonderful people at Diabetes Hands Foundation created the Big Blue Test and this year it's going on for TWO WEEKS! If this isn't motivation enough to get to the gym I don't know what is.

What is the Big Blue Test? It's simple. You test your blood sugar. Do some sort of physical activity- I run and do yoga but you could do walk, play tennis, curl, even throw darts- for 15 minutes or more. Then test again. You'll be pleasantly surprised how much your glucose levels drop. After that, head over to the Big Blue Test website and enter your results. There you can see how others are doing and how much progress we need to meet the goal of 8,000 tests by November 14th.

You need to have diabetes to participate, but do encourage your friends to share in your activity. There's nothing more motivating than a workout buddy!

Physical activity is so important for everyone. When you test before and after your workout, it is amazing to see how much more efficient your body is with carbohydrates and glucose. I notice my results all day long. I also feel that when I am being more active, my body craves healthier foods. I want to feed myself better things because my body feels better. Perfect example- I was just craving something sweet so instead of reaching for a cookie, I had a handful of grapes. My sweet craving was satisfied and I felt good about what I was eating.

If lowering your blood sugar levels wasn't motivation enough, you should know that Roche Diabetes Care is again sponsoring the Big Blue Test and making a donation that will support 8,000 people with diabetes who are in need. So, the more people who participate in the Big Blue Test, the more money Roche will donate. The money will go to people in here in the United States as well as in Latin America through the International Diabetes Federation's Life For a Child Programme.

Get out there, test, do your activity and report back! It's so awesome to be able to do this as a community. Helping people in need, all by testing, doing an activity, and testing again. It's so simple and such an amazing thing.Issues 2 of My New Shadow Diabetes Comic ReleasedWednesday, November 02, 2011 9:00 AMLast month, we introduced the new diabetes comic book series where you write the story. Issue #2 is out, and you can you can view it online for free.  This issue tackles Rachel's first trip to the doctor and that night at home with her family. It's not all smooth sailing.

Now, where should the story go next? Read it and share your thoughts on the site.InsightWednesday, November 02, 2011 1:04 AMI've written several times - probably too many times - about how much I dislike loading my pill sorters.  I've even done art about it. But, until recently, I've never had a feeling (beyond sloth, of course) why that should be the case. But I think I've got some insight into it.

I take medication not only for diabetes but also for a couple of other things that are high on the list of allegedly preventable diseases. And while I really don't believe that these conditions are my 'fault', there's no denying that my choices have had a role in their development. So, my weekly session with all those pills brings me face to face with type 2 guilt. I not only have to acknowledge these conditions while doing the counting, I have to wallow in that acknowledgement. These feelings are regrettable and unnecessary, but they're very real.

In addition to the conditions I've already mentions, I also take medications for a couple of things I see as being pretty purely genetic, and the pills for those are not nearly as "loaded" for me. And counting out the supplements I take even leaves me feeling good, as if I'm being wise and proactive.

When I was a kid, I had to take medicine for a chronic condition for a number of years. While I'm sure no one intended to convey this message, the attitude of my parents left my feeling that this condition meant that I was somehow flawed or inadequate and that my situation was one to be ashamed of. (I'm sure that my basic nature left me especially open to developing that sense.) I'm confident that my feelings from this time influence my feelings about my diabetes treatment. (Wanna know something odd? I kinda like testing my blood sugars. True confession.)

Now that I've had these insights, my feelings about my pills seem a bit silly, and I hope I'll be able to deal with them a little more effectively.There's a Reason to BelieveTuesday, November 01, 2011 3:30 PMDiabetes Research Institute Building

The Diabetes Research Institute Foundation is a non-profit research program that invests tens of millions of dollars searching for a cure every year. This entire six story building is full of researchers working to make sure that our kids and grandkids have lives free of diabetes. Think of that: six stories of passionate, brilliant people fighting for you!

Please check out their Reason2Believe fundraising campaign this diabetes awareness month. Share it with your friends and family. Forward it on to anyone that you know is touched by diabetes.

If you've ever thought, "I really wish there were more people working on a cure," then this organization is for you. Support them. Promote them. Finance them. Because it makes a real difference. Not only is this building full of researchers, but they have also partnered with hundreds of others around the world to share research and ensure progress.Words fail me...Monday, October 31, 2011 10:59 PMAnd when I think of the weeks that have just passed, the people I have met, the brief moments that we shared and the memories that were made….

Words fail me.

When I think on hours spent in cafes, in hotels, in bowling alleys and public squares.

Words fail me

When I think on the tears, of people who have shaped my broken life. Of avatars taking on flesh and bone, of Twitter handles becoming real personalities; of folk traveling miles to meet complete strangers….

Words fail me.

When I think on where I have been, of a broken disconnected life; of diabetic complication after complication, of proliferative retinopathy, cataracts, countless number of laser treatments, DKA, major surgery, hours spent in doctors’ rooms, innumerable infections and months spent wallowing in self-pity and defeat….

Words fail me

When I read the blogs of close friends, watch their videos and view their photos…..

Words fail me

When all is said and done I am just one lucky guy with amazing friends. An isolated broken down Australian who dared to believe in a dream and lived to relate the fairytale. Just one person who found in an online community, a network of friends to carry him through the darkest period of life to the dawning of a new day.

In many ways my journey has just begun but I owe most all that I have to the friends and “family” I have made in the Online Community. I am honored to have met such wonderful people and still pinch myself when I think of our real life get togethers.

To each and every one of you who dared to share their lives in a blog post, a tweet or a forum I offer up a thank you. To those I shared time with in the US...to Caroline, Cherise, the two Scott’s, the two Kelly’s, Jeff and Lisa, Mike, Sara, Courtney, Kim, Victoria, Jess, Heidi, Cara, Jon and Barb, Maria, Stephanie, George, Bob, Melissa, Allison, Kerri, Briley, Stacey, Patrick, Tina, Miriam and so many more…..

When I try to express all that you have and continue to do for me….

Words fail me!Goodbye Glucometer: New device could make pinpricks history for diabeticsSunday, October 30, 2011 6:03 AM

This week, two scientists, formerly students at MIT's George R. Harrison Spectroscopy Laboratory, announced they had further refined a device that could let we diabetics monitor blood sugar levels without piercing our fingers several times daily. The Raman spectrograph works by shining a low-powered laser though the thin fold of skin between the thumb and forefinger, eliminating the need to draw blood.  They have reduced the size of the previous prototype (a tabletop's worth of equipment) to the current prototype (which is the size of a shopping cart). The corresponding tests would take about one minute.

As most of us can imagine, it wouldn't be too convenient to push along our glucometer shopping carts all day (unless of course, someone was pushing you to work down a hill . . . =whee!). The scientists are working to reduce the size of the device to a portable level.

This story was like a walk down memory lane to the time I received my first glucometer at the age of six. The thing was the size of a car battery (I may be exaggerating here, but I was six years old and my hands were a lot tinier). I remember this thing vividly—it took about half the size of a dime's amount of blood, and had a sixty second countdown. During those sixty seconds, if you so much as TOUCHED the machine or looked at it funny, you would get a giant beeping ERROR message and have to start the process all over again. Three or four of such errors in a row could leave you feeling dizzy and in need of a transfusion. Every few days, you would need to disassemble the interface of the glucometer, to clean off the dried blood that had seeped into its machinery. A tummy-churning routine to be sure.

I've met people in the recent past though who were vehemently attached to their old gigantic glucometers and unwilling to part with them as technological advances streamlined the size and efficiency of the machines. There's something eerily familiar and comforting about those tiny pinprick calluses on our fingers and the hunks of machinery that are our glucometers.

Who am I kidding—I am definitely one of those people who heart their glucometer more than is psychologically healthy. We go for windy walks together, and I spend long stretches of my life gazing at its little screen longingly. Plus, after watching Kubrick's 2001: A Space Odyssey, I have a complete phobia of new technology—I am completely afraid that the new blender on my kitchen counter is plotting to kill me, and a new glucometer would probably be met with the same scrutiny and be forced to sleep outside my bedroom in a locked cabinet.

In order for me to jump ship from my current model to a new version, it would need one of the following features:

    rainbow sparkles and/or glitter
    a button which plays the Final Countdown upon command
    an accuracy of 99.99%
    a 100% non-evil rating and a guarantee that it will not turn into HAL and try to bump me off

What about you? How attached to your glucometer are you? What would it take for you to switch?

Check me out on Facebook, or come on over and take a gander at my blog :DMy life as a Diabetic Camel: The things she carriedThursday, October 27, 2011 8:00 AM

(Photo courtesy of ForestForTrees)

Often, when I traipse around town I am surrounded by chic, fashionable women wearing all level of expensive looking and teeny-tiny things. With the wealth of Diabetic crap I need to carry on a daily basis, I am more likely to resemble a camel or at the very least, a Sherpa than the decked out walking fashion plate. A quick inventory today found all these things in my purse:

    two juice boxes
    roll of glucose tablets
    glucometer
    vial of insulin and syringe
    back-up pump tubing
    spare batteries for both insulin pump and glucometer
    the "don't panic--if I'm in seizure this is what you need to do" cards in my wallet
    extra clip/case for my insulin pump
    plastic covers for insertion site
    kitchen sink
    rubber life raft and lifejacket
    flares

Well, you get the idea. I know marines who pack less than this.

When I look through this assorted mass, I long for one of those sleek, chic bags only holding a lipstick and wallet. But the few times I've been caught without these supplies when needed has turned into an ordeal of epic proportions. Have you ever been low, on the brink of passing out, without a juice box or glucose tablet in sight? The usual heart palpitations of low blood sugar are amplified about 100 fold to a feeling of pure terror. We're talking terror of ginormous proportions.

At the age of 12 or so, such an experience hit me whilst in the mall (this of course was that phase where I wanted to look like my friends, so the bulging backpack was out). The low reaction hit suddenly, I excused myself (I wouldn't want to look weird!), and proceeded to stroll to the mall food court and eat the leftover half of a chocolate bar some random patron had left on their table. The food court cleaning woman gave me a strange look, to which I stood still, likely as a squirrel who's been spotted by a farmer acts, hoping their absence of motion will render them invisible. Within a couple of minutes, my blood sugar returned to normal, and (thumbs up!) I didn't have to eat someone else's garbage! I skipped to the Gap and resumed my suburban right to try on khakis at the Gap.

That was the end of such pretensions of supply avoidance. I'd much rather have a potential hernia from heavy supplies than be caught mowing down on someone's leftover mall lunch.

Today, I've taken to writing lists compulsively to ensure that I have all the backup supplies and fixins on hand for such an emergency. I can't believe how hard it can be, for instance, to find a replacement battery for a glucometer when the issue presents itself. The moral of the story? Bring on the hernia: I'd much rather have ugly-abundance-of-supplies issues than hypoglycemic-fueled random terror and food lust.

What about you? Any solutions to the ugly mass problem of being a Diabetic? Drop me a line, as I'm desperate to hear of chic solutions.

Check out Megan on Facebook, or follow on Twitter @MeganRadford TRAILER: Big Blue Test Is Almost Here! (Video)Wednesday, October 26, 2011 6:42 PMThe Big Blue Test is from November 1 to November 14, World Diabetes Day. It's easy to participate: you test your blood sugar, get active, test again, and share the results. That's it. Not only will it help you, but for every person who participates someone will receive a donation of life-saving diabetes supplies.

To get you in the mood, here's the 2011 Big Blue Test Trailer:

Driving 225 mph with DiabetesWednesday, October 19, 2011 5:34 PMCharlie Kimball, Indy Car Driver with Type 1 DiabetesOn Saturday morning, I was in the garage of the IndyCar Series championship in Las Vegas. Charlie Kimball's car was revved up to 10,000 rpm as his team made final tweaks to the engine. In an hour, he would be propelled by the power of 650 horses around a steeply banked track at 225 mph (360 kmh).

Charlie has type 1 diabetes. In a sport where inches matter, he competes at the highest level against those with fully functioning pancreases.

Imagine: you are speeding forward for two hours at speeds 25% faster than a Boeing 747 takes off. Your only break is when you stop in the pit to have your tires changed and gas tank filled. That lasts 8 seconds. On top of it all, you need to do the complicated dance of balancing blood sugars.

And the stakes are high. Thirteen laps into Saturday's event, a racer misjudged a distance of inches, touched another drivers tire, and triggered a 15 car crash that killed two-time IndyCar champion Dan Wheldon.

It's impressive that someone can manage diabetes in such a high stress, high performance environment. People like Charlie Kimball push the boundaries of what is possible and show that diabetes is no barrier to reaching excellence and achieving your dreams.

Disclosure: I was at the Indy Car series to receive a grant from Novo Nordisk on behalf of the Diabetes Hands Foundation. Novo Nordisk provided transporation, hotel, meals and tickets to the race.

Charlie Kimball's IndyCarEverything's ConnectedMonday, October 17, 2011 3:32 AMA few weeks ago, I started noticing a little bit of pain in my left ear. I shrugged it off, figuring that I'd just gotten a little over-enthusiastic cleaning out my ears with a cotton swab. (Kids, people smarter than Uncle Bob know that cotton swabs are not to be used to clean out ears. Uncle Bob doesn't know what they ARE for, however.)

Around the same time, I also noticed that my blood glucose numbers were misbehaving. High fasting readings and crazy stupid reactions to even modest amounts of carbohydrates. I was getting a little scared.

Because real life isn't as easy as a blog post, it took me several days to consider a connection between the ear and the BGs. I went to an urgent care clinic and was diagnosed with an outer ear infection. Later that morning, I picked up the prescribed ear drops. Within. A few days, the modest amount of pain I had experienced was gone.

There are interrelationships between diabetes and the other things that go on in our bodies. Because I usually test reasonably regularly, and increase testing when something seems odd, I caught my ear infection before it became more serious. Because I'm aware that infections can cause wonky BGs, I took the possibility of an ear infection seriously when it occurred to me. On th other hand, diabetes can make us more prone to infections, so there may have been a relationship that way, too.

One way or another, everything about our health is connected.

(PS: Yes, I'm still here.)

How Long Should Insulin Be Used Once a Vial Is Started?

+ Author Affiliations

1. ¹Department of Medicine/Endocrinology, Albert Einstein College of Medicine, Riverdale, New York
2. ²Metabolism Department, Medical information Services, Aventis, Bridgewater, New Jersy
3. ³Eli Lilly, Indianapolis, Indiana
4. ⁴Medical Director, Novo Nordisk Pharmaceuticals, Princeton, New Jersey
5. ⁵National Vice President, Clinical Affairs, American Diabetes Association, Alexandria, Virginia

1. Address correspondence and reprint requests to Martin M. Grajower, Assistant Clinical Professor of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 3736 Henry Hudson Pkwy., Riverdale, NY 10463. E-mail: grajower@msn.com

• ADA, American Diabetes Association

Editor’s comment: The commentary by Dr. Grajower has such important clinical relevance that responses were invited from the three pharmaceutical companies that supply insulin in the U.S. and the American Diabetes Association, and all of these combined in this commentary. The commenting letter and individual responses were authored separately and are completely independent of each other.

Diabetic patients treated with insulin, whether for type 1 or type 2 diabetes, are prone to often unexplained swings in their blood glucose. These swings can vary from dangerously low to persistently high levels. Most diabetic patients, and most physicians, will adjust insulin regimens so as to avoid hypoglycemia at the expense of hyperglycemia. Among the “textbook” reasons for variable glucose responses to any given insulin regimen are 1) site of administration, 2) exercise, 3) bottles not adequately mixed before drawing the insulin (for NPH, Lente, or Ultralente), and 4) duration of treatment with insulin (1).

A new insulin was marketed by Aventis Pharmaceuticals about 1 year ago, insulin glargine (Lantus). The manufacturer seemed to stress that patients not use a started bottle of this insulin for >28 days (2). Two patients of mine highlighted this point.

L.K. is a 76-year-old woman with type 2 diabetes, diagnosed at 55 years of age, and treated with insulin since age 56. Her insulin regimen was changed to Lantus at night together with Novolog before meals. She monitors her blood glucose four times a day. She used a bottle of Lantus until it ran out; therefore, a bottle lasted for 2 months. Her recent HbA_1c was 7.6%. I retrospectively analyzed her home glucose readings by averaging her fasting blood glucose levels for the first 15 days of a new bottle and the last 15 days of that same bottle. The results were 137 ± 20 and 187 ± 13 mg/dl, respectively.

E.T. is a 77-year-old man with type 1 diabetes since 29 years of age. His regimen was changed from Humulin N plus Lispro to Lantus at bedtime and Lispro before meals. He checks his blood glucose levels four times a day. He observed on his own that the last 25% of his Lantus bottle didn’t seem as potent as the first 75% and questioned me about this. I asked him how long a bottle of Lantus insulin lasts for him. He told me 40 days (consistent with his dose of 25 U/day). Simple math revealed that his last 25% was past the recommended 28 days.

I set out to review the available literature on insulin storage. Lilly recommends using an opened bottle of Humulin R for 4 weeks, Humalog for 4 weeks, and Humulin N for only 1 week, whether refrigerated or at room temperature. Humalog Mix 75/25, Humulin 70/30, and Humulin N cartridges can be used for 7–10 days (3). Novo Nordisk states that vials or cartridges of Novolog can be used for 28 days at room temperature but says nothing about how long it will last if refrigerated (4). In a private communication with a staff pharmacist at Novo Nordisk, I received the following message: “If human insulin vials that are stored under refrigeration are used beyond 30 days, the stability of human insulin vials is dependent upon a number of factors in addition to temperature [sic]. These factors include the number of injections per day, volume of insulin remaining in the vial, exposure to light, agitation, and technique used for dose preparation. The impact of these factors is difficult to measure and the health professional should advise patients on an individual basis concerning long-term storage of opened insulin vials when refrigerated.”

An exam review for pharmacists lists the expiration date for opened vials of Humalog as 4 weeks, but other vials of human insulin are listed as 30 days unrefrigerated and 3 months refrigerated. Cartridges of R and Lispro are listed as stable for 4 weeks and 70/30 or N for 1 week (5).

I dare say that most physicians are not aware of the potency of the various insulins once a cartridge or vial is opened. This is probably due to a combination of reasons: contradictory information in print (as illustrated above), lack of adequate dissemination of this information, and lack of real data on this subject.

Indeed, the comprehensive, well-written, and up-to-date American Association of Clinical Endocrinologists (AACE) Diabetes Guidelines do not refer to the issue of storage of an opened vial or cartridge at all, either as an issue for the physician to be aware of or as a point of discussion with patients as part of their self-management (6).

A search of the American Diabetes Association (ADA) website on the subject of storage revealed the following comment: “Although manufacturers recommend storing your insulin in the refrigerator, injecting cold insulin can sometimes make the injection more painful. To counter that, many providers recommend storing the bottle of insulin you are using at room temperature. Most believe that insulin kept at room temperature will last a month or so” (7).

It seems to me that the ADA should be able to issue a more authoritative (i.e., evidence-based) statement than “most believe.” And what does “a month or so” mean? Given the 10-day manufacturer recommendation for Humulin N or 70/30, does that fall within the month? Is my patient’s 40 days on Lantus considered a month?

When addressing the issue of insulin storage in the ADA’s Clinical Practice Recommendations 2002, it is stated that “The patient should always have available a spare bottle of each type of insulin used. Although an expiration date is stamped on each vial of insulin, a loss of potency may occur after the bottle has been in use for >1 month, especially if it was stored at room temperature” (8).

The importance of not using bottles past their expiration date after opening is critical to good patient care. It is also an important cost issue. Many patients will be forced to throw out unfinished bottles of insulin. If the patient pays out-of-pocket, this increased cost could certainly spur the patient to continue using the bottle anyway, especially if he/she doesn’t monitor glucose levels on a regular basis and therefore doesn’t even see the difference between using a fresh or expired bottle. Do patients covered by prescription plans get enough insulin bottles to abide by the manufacturers’ recommendations or do they calculate the number of bottles required by how many units the patient takes on a daily basis? Why can’t manufacturers make smaller bottles of insulin for those on smaller daily doses to reduce wastage?

I have written this article with the following goals: 1) to increase awareness among physicians that storage of opened bottles of insulin is an important variable in controlling diabetes, 2) to spur manufacturers to present to the medical community scientifically rigid data on the expiration of their various insulins once opened and whether refrigeration affects this stability, 3) to then take these data and incorporate them into all future recommendations for the treatment of diabetic patients, whether taught by a physician, diabetes educator, nurse, or patient-oriented organization, and 4) to encourage pharmaceutical companies to manufacture smaller bottles of insulin to reduce the cost of wasted insulin.

 

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RESPONSE FROM AVENTIS

We appreciate the opportunity to respond to Dr. Grajower’s request for information regarding Lantus (insulin glargine [rDNA origin] injection) and the following associated topics: stability information and prefilled syringe stability. Lantus is indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes or adult patients with type 2 diabetes who require basal (long-acting) insulin for the control of hyperglycemia.

Warnings

Hypoglycemia is the most common adverse effect of insulin, including Lantus. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.

Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, timing of dosing, manufacturer, type (e.g., regular, NPH, or insulin analogs), species (animal and human), or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need to change dosage. Concomitant oral antidiabetes treatment may need to be adjusted. Lantus must not be diluted or mixed with any other insulin or solution.

Stability information

The following information is stated in the Lantus package insert (2):

Storage.

Unopened vial: Unopened Lantus vials should be stored in a refrigerator at 36–46°F (2–8°C). Lantus should not be stored in the freezer and should not be allowed to freeze. The vial should be discarded if the contents are frozen.

Open (in-use) vial.

Opened vials, whether or not refrigerated, must be used within 28 days. They must be discarded if not used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days in a place away from direct heat and light, as long as the temperature is not >86°F (30°C).

This letter briefly describes the analytical processes and testing procedures used to support the labeled stability. The stability of Lantus has not been evaluated in containers other than those described for commercial distribution, nor has it been evaluated under physical conditions other than those described herein. Stability under other circumstances cannot be inferred from these data.

Analytical procedures

Lantus stability testing assesses the following parameters (Aventis, data on file): 1) appearance, 2) particulate matter, 3) sterility and bacterial endotoxin content, 4) pH, 5) insulin glargine and noninsulin glargine protein content, 6) preservative (m-cresol) content and stability, and 7) active insulin glargine content (bioactivity). Unless otherwise stated, Lantus met or exceeded stability requirements in these studies (Aventis, data on file).

Stability testing

Photostability.

Lantus was found to degrade after extended exposure to either room light or artificial sunlight (Aventis, data on file). Due to this finding, all other stability testing was conducted in an environment protected from light. When not in active use, Lantus should be protected from light. An in-use vial of Lantus is stable in room light for a period of 28 days. Lantus should be protected from direct sunlight.

In-use stability (open vial).

The in-use stability of Lantus was assessed over a 4-week period with or without refrigerated storage (Aventis, data on file). During the study, 2 units of Lantus were removed each day and discarded. The samples were stored at either 41 or 77°F (5 or 25°C) for a period of 28 days. The remaining product after 4 weeks met all stability criteria. It is recommended that Lantus be discarded after 28 days following the first use, regardless of refrigeration.

Long-term storage stability (unopened vial).

Lantus was found to meet stability criteria for at least 24 months when stored between 36 and 46°F (2 and 8°C) (Aventis, data on file). Accelerated stability testing at 77°F (25°C) revealed a slight loss in activity by 9 months. Testing at 95–102°F (35–39°C) for 1 month revealed an increase in impurities without loss of activity. Lantus should be stored in a refrigerator to maintain the labeled expiration date. In the absence of refrigeration, unopened vials of Lantus should be discarded after 28 days.

Adverse shipping condition stability.

The stability of Lantus was determined under conditions mimicking extreme temperature changes that may occur during shipment (Aventis, data on file). Two separate 28-day investigations of temperature fluctuations from 5 to 77°F (−15 to 25°C) and from 41 to 77°F (5 to 25°C) were conducted, with repeating cycles of 4 days at the lower temperature and then 3 days at 77°F (25°C). The content of Lantus did not change appreciably under either set of conditions and met stability criteria.

Summary

Unopened Lantus stored under refrigeration and without freezing will maintain stability to the expiration date stated on the packaging (Aventis, data on file). Should Lantus freeze, it should be discarded. If refrigeration is not available, unopened Lantus may be stored at controlled room temperature (≤86°F, ≤30°C) for a maximum of 28 days. Lantus should be discarded 28 days after first use, regardless of refrigeration.

Prefilled syringe stability

The stability of Lantus when it is prefilled into syringes and stored up to 7 days was evaluated using four different types of syringes (Aventis, data on file). The following syringes were tested (200 syringes of each type): 1) BD Ultra-fine, U-100, 0.5 ml, 30 G ×½ inch (Becton Dickinson [BD]); 2) BD Ultra-fine II (short needle), U-100, 0.5 ml, 30 G × 5/16 inch (BD); 3) Walgreens super thin syringes, U-100, 0.5 ml, 29 G × ½ inch (Walgreens); and 4) Reli-On insulin syringes, U-100, 0.5 ml, 30 G × 5/16 inch (Wal-Mart).

The syringes were stored either at 41°F (5°C) or 77°F (25°C) for up to 7 days, after which the Lantus solution was tested for filtration time, byproducts, insulin glargine content, and m-cresol (preservative) content. The Lantus solution was visually inspected and pH measured every day (except days 4 and 5). Microbial contamination was not evaluated in this study.

Results

Visual appearance at 41°F (5°C).

The Lantus solution became turbid more quickly in the Walgreens syringes compared with those of BD and Reli-On. By day 3, the Lantus solution was turbid in all four syringe types. After 2 days of storage in the Walgreens syringes, the Lantus solution did not meet specification.

Visual appearance at 77°F (25°C).

The Lantus solution became turbid in the Reli-On syringes by day 2, and turbidity occurred in the Walgreens and BD Ultra-fine II syringes by day 3. After 6 days of storage in the Walgreens syringes, the Lantus solution did not meet specification. A placebo solution stored in the Walgreens syringes at each temperature did not become turbid over 7 days.

Insulin glargine content, byproducts, filtration, and pH.

For each syringe type, the Lantus solution complied with specifications.

m-Crescol content.

For each syringe type, the Lantus solution complied with specifications.

Summary

Aventis Pharmaceuticals does not recommend prefilling syringes with Lantus and storing for any period longer than needed for application. In addition BD states the following (9): “BD does not recommend that any of our syringes be prefilled more than a few minutes in advance of the injection. There are no conclusive studies to determine the safety or risks associated with this practice.”

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RESPONSE FROM ELI LILLY

We appreciate the opportunity to respond to Dr. Grajower’s letter concerning in-use dating of insulin products manufactured by Eli Lilly. There are many issues affecting recommendations for storing insulin, and the labeling is controlled by global regulatory agencies, including the U.S. Food and Drug Administration. Considering the large number of factors that go into these recommendations, it is not surprising that there may be confusion about insulin potency during use.

When unopened vials, cartridges, or prefilled insulin pens are stored at the recommended temperatures (between 36 and 46°F [2 and 8°C]), insulin may be used until the expiration date printed on the insulin container or carton. At expiry, regulatory requirements state that the insulin product must retain at least 95% of its labeled potency.

However, once an insulin product is in use, the recommended durations of in-use differ depending on the particular formulation of insulin (regular, NPH, Humalog, etc.), its primary container (vial or cartridge), the ambient storage conditions (room temperature or refrigerated), and regulatory requirements.

Two main factors influence recommended in-use durations: sterility of the product and potency. Eli Lilly establishes guidelines for storage based on recommendations by the Committee for Proprietary Medicinal Products (CPMP), with particular reference to guidance on sterile products for human use, which includes insulin products (10). Insulin products are sterile until the first dose is withdrawn by syringe or expelled from a cartridge. After first use, the contents of the vial or cartridge are technically no longer sterile, despite the presence of antimicrobial preservative agents, such as metacresol and phenol or methylparaben, in concentrations adequate to kill or retard the growth of small microbial challenges. Sterile products should be used in as short a time as possible to minimize concerns about microbiological contamination once the container has been opened or punctured. The CPMP has proposed a maximum-use period of 28 days for sterile products containing preservatives, including insulin products.

The chemical potency of insulin is measured by high-performance liquid chromatography and is unrelated to the above discussions of in-use dating relative to preservative effectiveness. At the time of manufacture, insulins available in the U.S. have a label potency of 100 units/ml. However, regulatory limits allow for ±5% variation around that standard. Internal standards for insulins manufactured by Eli Lilly are within ±3.0% at the time of release. At room temperature, the degradation of insulin is an approximately linear function. At elevated temperatures, insulin loses chemical potency, which is accelerated as the temperature increases. For example, at room temperature (77°F), insulin will lose <1.0% of its potency over 30 days, or <0.03% potency lost per day. In contrast, insulin stored in a refrigerator will lose <0.1% of its potency over 30 days (Lilly Research Laboratories, data on file). For this reason, and to maintain consistent temperature exposure, we recommend that any unused insulin be refrigerated. Importantly, the relatively small amount of degradation products that develop during storage, such as B-3 and A21-desamido insulin, remain partially biologically active. Although refrigeration should be used when possible, the loss of the biological potency of insulin is so slow that if one carefully protects insulin supplies from extreme temperature, any losses of potency should have minimal, if any, effect on the control of diabetes. Ultimately, although “main peak” chemical potency as measured by high-performance liquid chromatography may decrease over time, the effect on insulin biological potency may be minimal.

Patients should not use insulins that have changed in appearance due to heat exposure or freezing. Freezing will cause modified insulins (i.e., those containing a precipitate such as NPH insulin, Ultralente insulin, or Lente insulin) to resuspend improperly after thawing, reducing the accuracy of dosing.

The in-use dating differences between vials and cartridges are primarily due to the reduced volumes, increased agitation, and potentially variable temperature exposures of a cartridge or prefilled pen during use. Therefore, the in-use dating recommendation for pens and cartridges is for somewhat shorter times than that for vials, reflecting the reduced volumes and the environment to which these products might be exposed. These recommendations may be found in the “Information for Patients” document included in insulin products.

In conclusion, the recommended in-use period for insulin is based primarily on a number of factors and regulatory requirements, particularly relating to sterility of the product. Chemical and biological potency are not the determining factors in storage recommendations for insulins.

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RESPONSE FROM NOVO NORDISK

Thank you for sharing this letter regarding insulin storage guidelines. Novo Nordisk shares the commitment of health care professionals that insulin storage and handling should be appropriate to maintain consistent and predictable glycemic effects. We agree that storage and handling guidelines are essential for the patient to use insulin safely and effectively on a daily basis, in a variety of situations. We offer the following information regarding proper use of insulin formulations manufactured by Novo Nordisk.

General guidelines of insulin storage and handling

In general, insulin formulations should be inspected for physical changes, such as clumping, frosting, precipitation, or discoloration, that may be accompanied by a loss of potency. Insulin formulations should be optimally stored at refrigerated temperatures (36–46°F, 2–8°C) before use (1). Insulin formulations should never be allowed to freeze.

Extreme temperatures or excess agitation should be avoided during storage to prevent loss of potency of the formulation. Regardless of the temperatures experienced during storage, insulin formulations should never be used after the expiration date printed on the label and carton.

When a formulation is in use, insulin should be kept unrefrigerated to minimize local injection site irritation, which may occur after injection of cold insulin solutions (2). Unrefrigerated insulin formulations that are in use should be kept as cool as possible and away from excess heat or sunlight (11).

Storage guidelines: vials of Novolin R, Novolin N, Novolin 70/30, Novolin Lente, or Velosulin BR

The U.S. Pharmacopoeia Dispensing Information provides the following recommendations for storage of insulin vials: “An insulin bottle in use may be kept at room temperature for up to 1 month. Insulin that has been kept at room temperature for longer than 1 month should be thrown away” (11).

The ADA reminds health care professionals that even though each insulin vial is stamped with an expiration date, a slight loss of potency may occur after the vial has been in use for >30 days, especially if stored at room temperature (12). If human insulin vials are stored under refrigeration while in use and are used beyond 30 days, the stability of these vials may be affected by a number of factors. Such factors include the number of injections per day, volume of insulin remaining in the vial, exposure to light, agitation, and technique used for dose preparation. The impact of such factors is difficult to measure, and the health care professional should advise patients on an individual basis concerning long-term storage of opened insulin vials when refrigerated.

Storage of NovoLog (insulin aspart [rDNA origin] injection)

Unused vials of NovoLog should be stored under refrigeration between 36 and 46°F (2 and 8°C). The formulation must not be frozen. Do not use NovoLog if it has been frozen or exposed to temperatures in excess of 98.6°F (37°C). After a vial of NovoLog has been punctured, it may be kept at temperatures <86°F (30°C) for up to 28 days but should not be exposed to excessive heat or sunlight. Opened vials may be refrigerated.

NovoLog in the reservoir of an external insulin delivery pump for use during continuous subcutaneous insulin infusion should be discarded after no more than 48 h of use or after exposure to temperatures that exceed 98.6°F (37°C).

Novo Nordisk prefilled delivery systems and insulin cartridges

Prefilled pen and cartridge forms of insulin formulations (which contain 3 ml insulin rather than 10-ml vials) can be used to minimize waste of unused insulin. Since a prefilled pen or cartridge contains 300 units versus the 1,000 units of a vial, it takes the patient less time to exhaust that insulin when compared with the contents of a 10-ml vial. This smaller amount of insulin can mean that it is more likely that insulin will be used within the recommended in-use time period. Insulin pen devices are already the predominant form of insulin use outside of the U.S. Novo Nordisk offers the prefilled insulin delivery systems NovoLog FlexPen insulin aspart injection (rDNA origin), NovoLog Mix 70/30 FlexPen 70% insulin aspart (rDNA origin) protamine suspension and 30% insulin aspart (rDNA origin) injection, and Novolin InnoLet human insulin (rDNA origin). PenFill cartridges are used in insulin delivery devices such as NovoPen 3, InDuo, and Innovo. Prefilled pens and reusable devices with the cartridge inside are stored at room temperature during use and thereby offer improved convenience and portability. The in-use times recommended for prefilled pen and cartridge products are based on simulated in-use conditions and room temperature storage.

NovoLog FlexPen or NovoLog Mix 70/30 FlexPen prefilled syringes

NovoLog FlexPen is a 3-ml prefilled syringe that contains insulin aspart [rDNA origin] (100 units/ml). NovoLog Mix 70/30 FlexPen is a prefilled syringe that contains 3 ml of a mixture of 70% insulin aspart protamine crystals and 30% soluble insulin aspart (rDNA origin). FlexPen syringes that are not currently in use should be stored under refrigeration (36–46°F [2–8°C]), but not in the freezer compartment. An in-use FlexPen device should be stored at temperatures <86°F (30°C) for 14 days for NovoLog Mix 70/30 FlexPen and 28 days for NovoLog FlexPen.

Storage of Novolin InnoLet human insulin (rDNA origin)

Novolin InnoLet is a 3-ml prefilled insulin doser that contains Novolin R, N, or 70/30 insulin. InnoLet dosers that are not currently in use should be stored in a cold (36–46°F [2–8°C]) place, preferably in a refrigerator, but not in (or near) the freezer compartment. An in-use InnoLet doser should be stored at temperatures <86°F (30°C) for 28 days for Novolin R InnoLet, 14 days for Novolin N InnoLet, and 10 days for Novolin 70/30 InnoLet.

Storage of Novo Nordisk reusable insulin delivery devices and PenFill cartridges

NovoPen 3, InDuo, and Innovo insulin delivery devices should be stored at room temperature. Unused Novolin PenFill cartridges should be kept in a cold place, preferably in a refrigerator, but not in the freezer compartment. Unused NovoLog and NovoLog Mix 70/30 PenFill cartridges should be kept refrigerated. Do not allow the PenFill cartridges to freeze. Keep unused PenFill cartridges in the carton so that they will stay clean and protected from light.

Novolin, NovoLog, and NovoLog Mix 70/30 PenFill cartridges currently in use should not be refrigerated after insertion into NovoPen 3, InDuo, or Innovo insulin delivery devices. In-use NovoLog and NovoLog Mix 70/30 PenFill cartridges should be protected from extreme temperatures and should be stored at temperatures <86°F (30°C) for 28 days for NovoLog PenFill and 14 days for NovoLog Mix 70/30 PenFill.

In-use Novolin PenFill cartridges should be protected from extreme temperatures and sunlight. Unrefrigerated in-use Novolin PenFill cartridges can be used 28 days for Novolin R PenFill, 14 days for Novolin N PenFill, and 10 days for Novolin 70/30 PenFill. Unrefrigerated PenFill cartridges should be discarded if not used within the time periods listed above. Storage at extreme temperatures should be avoided because the physical properties of the insulin may be altered.

Expiration dates for refrigerated unopened product and in-use times for opened room temperature product are based on data generated by Novo Nordisk and approved by regulatory authorities, such as the Food and Drug Administration, to ensure that the potency of a properly handled product is maintained while the product is in use. These times differ by brand and type of insulin, as well as by product presentation (i.e., vial versus cartridge), to ensure the longest in-use time without sacrificing potency. Proper storage and handling of insulin products is essential and must be considered as part of routine daily care by both the physician and patient when using insulin.

Novo Nordisk offers the aforementioned storage and handling guidelines for insulin vials, PenFill cartridges, and a variety of insulin pens and dosers to enable patients and health care professionals to use insulin safely and effectively. If you require any further information, please contact Novo Nordisk Pharmaceuticals at (800) 727-6500.

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RESPONSE FROM THE ADA

Thank you for asking the ADA to respond to Dr. Grajower’s letter. He raises several very important points regarding the storage of insulins and its possible effects on blood glucose control. His specific comments regarding the various insulins and what their manufacturers state regarding storage and product expirations will need to be addressed by the manufacturers themselves. If their guidelines were only evidence based, then they would have that data. I will comment on the general topic of insulin use as regards the guidelines that come from our 2003 Clinical Practice Recommendations. In general, patients are instructed that once opened, an insulin vial need not be refrigerated and can be kept at room temperature for ∼1 month. Extremes of temperature should be avoided because these can lead to significant changes in insulin action. How long an insulin can be stored while unopened is based on the expiration date.

Dr. Grajower raises an excellent point in stating that changes in insulin action can lead to significant changes in blood glucose control. In our 2003 guidelines, we state that “The person with diabetes should always try to relate any unexplained increase in blood glucose to possible reductions in insulin potency. If uncertain about the potency of a vial of insulin, the individual should replace the vial in question with another of the same type” (12). We agree that patients and providers need to consider changes in insulin activity as another important factor in evaluating changes in glucose control. Thank you for allowing us to respond.