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Correction: In the Letters to the Editor of the November issue (p. 61), we made an incorrect statement about the use of Lantus. The sentence should read "..those who take three meal-time shots of short-acting insulin plus basal Lantus will take four shots of insulin a day." We apologize for this error.
In December 2000, my 16-year-old daughter Melissa drew up her morning insulin using an Ultra Fine II syringe from Becton Dickinson (BD). There was an explosion when she injected, and the needle fell off the hub and got stuck in her arm. I had to take her to the emergency room.
Then, in April, it happened again. When my daughter drew up her insulin, the needle didn't come off in her arm, but it broke.
Does a company recall a product when something like this happens? I want to know if this has happened to others.
Editor's note: We asked Barry H. Ginsberg, MD, PhD, vice president of Medical Affairs at BD, to respond.
The health and safety of our customers is our #1 concern at BD. Therefore, we regret the experience that Mrs. Weatherford had with our syringes, and her dissatisfaction with our response. We always welcome communication from your readers and strive to provide the best possible response.
All BD products must meet the highest quality standards. Every lot of insulin syringes produced by BD, including the one in question, undergoes a battery of tests to ensure that they meet our standards. Among these is a test to verify that the hub will not separate from the syringe even if a high amount of force is exerted. We have received no other complaints about the separation of a hub from a syringe produced in the same production lot as Mrs. Weatherford's syringe. All the syringes tested from this production lot passed this test, and met or exceeded our standards. This is the reason that we did not find it necessary to recall any syringes as a result of Mrs. Weatherford's complaint.
We believe that excellent customer service is essential and continually work to monitor and improve our customers' satisfaction with the service we provide. Our representatives are highly trained in diabetes management and are available to discuss many aspects of insulin injection from insulin injection technique to syringe disposal. We invite your readers to call us at our toll-free number (888) BD-CARES (232-2737) Monday through Friday (9 a.m. to 5 p.m. Eastern Standard Time), if they would like to discuss our products and their use.
Barry H. Ginsberg, MD, PhD
Vice President, Medical Affairs
BD Consumer Health Care
Franklin Lakes, New Jersey
My Low-Carbohydrate Cookbook
I appreciate the latest information covered in Diabetes Health. My 7-year-old daughter was diagnosed with insulin-dependent diabetes last August.
I want to bring to your attention a low-carbohydrate cookbook I home-published, called "Low Carbohydrate Goodies and Treats That Kids Love to Eat!" This first-edition recipe collection is written especially for people with diabetes, but anyone interested in delicious desserts, snacks and beverages made with healthy ingredients would enjoy it too. A percentage of revenue from the sales will be donated to local organizations supporting awareness of diabetes in the community.
For more information or to purchase the recipe collection, visit my Web site at www.leilanisrecipes.addr.com.
Los Osos, California
Going Back to Ultralente
I've been taking Lantus as my basal insulin since September. While I really like taking one less shot a day, I've found it really doesn't work as well for me as two shots of Ultralente because my bolus requirement changes during the day. So I'm going to go back to taking Ultralente instead of Lantus.
Lantus Works Great for Me
After 37 years with type 1, Lantus had a huge impact on my ability to control my blood glucose levels with precision and ease.
Lantus is injected once per day at bedtime, lasts 24 hours, and is essentially "peakless," meaning that, in many cases, a single daily injection can provide the basal insulin requirement. A short-acting insulin is still required to cover for meals. But Lantus is much more flexible at mealtimes than when using the conventional intermediate- plus short-acting insulin regimen.
Conceivably, the disadvantages of Lantus, as opposed to pumping, would include an inability to deal with "dawn phenomenon" (when I was on two injections of NPH per day I used to think I had it, but now know I don't), and no way to stop basal insulin administration during intense physical activity. But, in the latter case, all that's needed is a supplemental snack that approximates the expected caloric expenditure.
Since I've been on Lantus, I've had two surgeries and one major procedure requiring anesthesia. There have been three times when I wasn't allowed to eat anything from midnight until mid-afternoon the next day. I took my usual dose of Lantus the night before, no short-acting insulin the day of the procedures, and my blood-glucose levels stayed between 88 and 130.
Tony Enos, RN
Los Angeles, California
Editor's note: Cindy Onufer, RN, MA, CDE, Diabetes Health's new medical adviser, responded to this reader's experience with Lantus.
Thank you for sharing your very positive experience using insulin glargine (Lantus) as your basal insulin in treating your type 1 diabetes. Many of my patients are also singing its praises as they use Lantus as basal and either insulin lispro (Humalog) or insulin aspart (Novolog) as the bolus insulin. This type of regimen gives more flexibility in lifestyle, less risk of hypoglycemia and helps keep HbA1cs in the target range.
I wanted to comment on your mention of dawn phenomenon, or the early-morning rise in blood glucose related to changes in certain hormone levels. It is advised that people confirm (by checking nighttime blood-glucose levels, usually at 3 a.m.) that the morning rise is not due to a rebound (Somogyi) response of the body to undetected nighttime hypoglycemia. This could be due to such things as the peaking of NPH insulin during the night, delayed response to exercise, etc. If this is the case, action can be planned by moving the NPH to a later time and/or taking a lower dose if that is the culprit.
If dawn phenomenon does exist, however, there is another choice short of starting insulin pump therapy (with programmed basal rates to counter the early morning rise in BG). A person could continue taking Lantus as a single bedtime injection for 24-hour basal insulin, but also take a small dose of Lente or NPH insulin at bedtime to treat the dawn phenomenon.
This, of course, would be as a separate injection, as Lantus cannot be mixed with any other insulin. I know of several people who use this plan successfully. Again, thank you for sharing.
Cindy Onufer RN, MA, CDE
Study Shows Trans Fats May Cause Diabetes in Women
I wanted to pass along an interesting news clip from the October issue of the Nutrition Action Healthletter, which is published by the Center for Science in the Public Interest (CSPI). The article entitled "Trans & Diabetes" talks about a study that was published in the June issue of the American Journal of Clinical Nutrition.
The article states, "It's too early to say that trans fat causes diabetes, but a new study shows that women who consume more trans have a higher risk" of getting type 2 diabetes. In the study, cholesterol-rich foods were also linked to a higher risk of type 2 diabetes. Polyunsaturated fats (found largely in vegetable and fish oils) were found to reduce the risk of type 2, which could be explained by the fact that cell membranes rich in polys may do a better job of admitting insulin from the bloodstream to the cells
Thanks so much and keep up the great work.
Silver Spring, Maryland
Less Meat Doesn't Lower Blood Sugar Levels
Regarding your research report saying that consuming less meat and sugar improves HbA1c levels ("Stick With Your Veggies," September, p. 19), my vegetarian patients do not have lower blood sugars than those who eat meat, fowl or fish. In fact, most have higher blood sugars.
I suspect that the significant factor in the research was the elimination of sugars. The study should have been designed to evaluate the effects of the two classes of foods separately.
Richard K. Bernstein, MD, FACE, FACN
Mamaroneck, New York
Is a Cure on the Way?
I was impressed with the article "Type 1 Diabetes Cured in Mice," (September, p. 16). The procedure sounds relatively simple and it has been successful so far.
Could a follow-up article be written expanding on the drug TNF-alpha and how it works to kill bad cells? How complicated is the process and are anti-rejection drugs necessary? Let's hear more about this one.
Tim F. Wonderlin
Editor's note: Thank you for your suggestion. We have, in fact, covered the diabetes cure research of Denise Faustman, MD, in more detail. Please see the article "The Diabetes Cure of Tomorrow" on page 33 of this issue.
Learning New Things in Diabetes Health
Being on an insulin pump for 21 years, I thought I had experienced everything until I read your first issue. Now, I learn something new each month with each issue of Diabetes Health.
East Haven, Connecticut
Response to A1cNow Letters
As the founder of Metrika, I am compelled to respond to letters from readers printed in your November issue ("Letters to The Editor," p. 12), containing unfounded accusations about the integrity of our company and the performance of our A1cNow device.
As to the question of accuracy, our A1cNow test has been shown to be 98 percent accurate compared to National Glycohemoglobin Standardization Program (NGSP)-certified laboratory methods. We recognize that the true measure of a test's performance is "total error"—a combination of accuracy and precision. When compared to current College of American Pathology (CAP) Survey data on total error, Metrika's A1cNow performance would be equivalent to a number of existing laboratory systems as they are actually used in the field.
Metrika fully supports NGSP efforts to standardize A1c results. As the first ever single-use device, A1cNow faces unique challenges in applying the NGSP's certification protocol, which is designed for instruments that process multiple samples in a laboratory environment. Metrika's goal is to obtain NGSP certification, and we are working closely with the NGSP to achieve this in the future.
Nonetheless, the A1cNow calibration is traceable to NGSP reference methods, as Metrika uses calibration materials whose value has been assigned by a NGSP reference lab. This calibration cannot be altered by end users, resulting in a reliable product free from lab-to-lab variation introduced by independent calibration. Additionally, the A1cNow automatically performs 25 internal quality control tests on each sample and delivers an error message rather than an erroneous result.
Metrika is preparing to introduce the A1cNow for in-office and prescription home use in the first quarter of 2002, and we are dedicated to working with the professional community to demonstrate the clinical utility of our product for improving diabetes care.
Michael P. Allen
Founder, CEO and Chairman
Don't Knock Pharmacies
I wanted to tell you that I am no longer interested in receiving Diabetes Health magazine. I am a community pharmacist who is tired of being put down in the magazine. People in my profession directly work with countless diabetes patients to help improve their compliance, prevent problems that can result from combining certain drugs and answer their medical questions. Yet, several of your advertisers say in their ads that their mail-order services are superior because there are "no pharmacy lines and hassles."
I also provide blood-glucose testing by appointment and have referred two patients with alarmingly high fasting glucose levels to their doctors. They have both called or stopped by to thank me for the advice because they were both diagnosed with diabetes. My practice also provides access to flu vaccines for people with diabetes.
I have always spoken highly of my profession to the public based on our skills and expertise, not by degrading others. I would strongly advise you to be more selective in what you allow your advertisers to include in their ads. Comments about long pharmacy lines demean my profession. I will not support them or magazines that publish their ads. I will encourage my colleagues to do the same.
Sherwood E. Peterson, Jr., RPh
Editor's note: We can certainly understand your position. As a community pharmacist, you know your customers and provide them with personal service. However, some individuals are limited by their location and do not have access to community pharmacists. Mail-order pharmacies provide a service to these people. Also, some people use mail-order pharmacies because their insurance companies dictate that they do so.
Correction: In the article "New Diabetes Drug Not Approved by FDA Advisory Committee" (October, p. 18), the drug Symlin (pramlinitide acetate) was incorrectly defined as a synthetic version of insulin. Symlin is a synthetic form of a natural hormone that helps regulate blood-glucose levels.