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Thursday, March 17, 2011

Hearing Loss Under-Recognized Complication of Diabetes

Hearing loss is about twice as common in adults with diabetes compared to those who do not have the disease, according to a study funded by the National Institutes of Health (NIH) and published in the Annals of Internal Medicine.

Diabetes may lead to hearing loss by damaging the nerves and blood vessels of the inner ear, research suggest. Autopsy studies of diabetes patients have shown evidence of such damage. (See my earlier post 'Diabetes and Hearing Loss' here.)

Yet hearing screenings typically are not part of the regular regimen of care that people with diabetes are routinely recommended to receive. Nor do the vast majority of doctors in today’s health care system include hearing health as a routine part of annual exams.

Hearing loss is one of the most commonly unaddressed health conditions in America today, and affects more than 34 million Americans. Six out of ten Americans with hearing loss are below retirement age.

"Hearing loss affects virtually every aspect of a person's life, making it all the harder for people with diabetes to cope with their disease,” says Sergei Kochkin, PhD, the Better Hearing Institute 's executive director. “A hearing check is invaluable in determining whether or not someone with diabetes does have a hearing loss and will help to ensure that they get the treatment they need."

"Hearing loss may be an under-recognized complication of diabetes. As diabetes becomes more common, the disease may become a more significant contributor to hearing loss," says senior author Catherine Cowie, Ph.D., of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), who suggests that people with diabetes should consider having their hearing tested. "Our study found a strong and consistent link between hearing impairment and diabetes using a number of different outcomes."

[In fact, recent research, reported this month in the American Journal of Kidney Disease, found persons suffering from moderate chronic kidney disease (a complication attributable to diabetes as well) are likely to have hearing loss and should receive regular screenings. Specifically the study found 54.4 percent of all the patients in the study with moderate CKD had some degree of hearing loss.]

Adults with pre-diabetes, whose blood glucose is higher than normal but not high enough for a diabetes diagnosis, had a 30 percent higher rate of hearing loss compared to those with normal blood sugar tested after an overnight fast.

Besides, numerous studies have linked untreated hearing loss to a wide range of physical and emotional conditions, including irritability, negativism, anger, fatigue, tension, stress, depression, avoidance or withdrawal from social situations, social rejection and loneliness, reduced alertness and increased risk to personal safety, impaired memory and ability to learn new tasks, reduced job performance and earning power, and diminished psychological and overall health.

BHI is highlighting the connection between diabetes and hearing health and is urging all Americans to take the Diabetes Risk Test and the Across America Hearing Check Challenge onAmerican Diabetes Association Alert Day℠. This year, Diabetes Alert Day is on March 22 and kicks off the "Join the Million Challenge"—a month-long effort to rally one million people to take the Diabetes Risk Test by April 22 to find out if they are at risk for developing type 2 diabetes.

"Diabetes Alert Day is a tremendously valuable initiative because it prompts people to take a simple Diabetes Risk Test and to make changes in the way they live so they can preserve their health," said Kochkin.

"It's also important that people with diabetes understand that they may be at an increased risk of hearing loss as a result of their disease. We urge anyone with diabetes to take the Across America Hearing Check Challenge, a quick and confidential online hearing test to determine if they need a comprehensive hearing check by a hearing professional."

[The American Diabetes Association Alert Day℠ is a one-day "wake-up" call to inform the American public about the seriousness of diabetes. The American Diabetes Association (ADA) encourages people to join the movement to Stop Diabetes by taking the Diabetes Risk Test to find out if they, or their loved ones, are at risk for developing type 2 diabetes.

To become part of the movement to Stop Diabetes and get a free Diabetes Risk Test (English or Spanish), individuals can visit stopdiabetes.com, call 1-800-DIABETES (1-800-342-2383) or text JOIN to 69866 (Standard data and message rates apply). Although Diabetes Alert Day is a one-day event, the Diabetes Risk Test is available year round.]

Wednesday, March 16, 2011

Diabetes Self-Monitoring: Shed a Tear to Test Blood Sugar Level

For a diabetic, nothing is more bothersome than self-testing to monitor blood sugar levels. Current monitoring devices typically require patients to perform the painful task of pricking their finger to draw blood for a test sample. And many patients must do it several times each day. Indeed, comments in one TuDiabetes forum over the past 6 weeks have underscored this issue.

Even as diabetics discuss lancet devices, painful pricks, first drop of blood, and callused fingertips, a team of researchers at the Arizona State University in collaboration with the Mayo Clinic is developing a new sensor that could make the lives of diabetes patients much easier.

Led by bioengineer Jeffrey T LaBelle, a research professor in the School of Biological and Health Systems Engineering at the ASU’s Ira A. Fulton Schools of Engineering, the team has come up with a new sensor which would enable patients to take tear fluid from their eye to test their glucose levels. The researchers claim the tear sample would give just as accurate a reading as a blood test does. The diagram above explains how the device works.

LaBelle correctly points out that the painful finger prick, which is the current norm, makes people reluctant to take the test. Glucose in tear fluid may give an indication of glucose levels in the blood as accurately as a test using a blood sample, the research claims.

“The problem with current self-monitoring blood glucose technologies is not so much the sensor. It’s the painful finger prick that makes people reluctant to perform the test. This new technology might encourage patients to check their blood sugars more often, which could lead to better control of their diabetes by a simple touch to the eye,” says LaBelle.

The research findings have been published in Journal of Diabetes Science and Technology (2:6, 307-11).

The research team comprises LaBelle, the designer of the device technology, and Mayo Clinic physicians Curtiss B. Cook, an endocrinologist, and Dharmendra (Dave) Patel, chair of Mayo’s Department of Surgical Ophthalmology.

The ASU-Mayo research team began the project with funds from a seed grant from Mayo Clinic. Researchers got assistance in the laboratory from ASU students involved in research at ASU’s Biodesign Institute and the Ira A. Fulton Schools of Engineering Fulton Undergraduate Research Initiative program.

Team members assessed how current devices were working – or failing – and how others have attempted to solve monitoring problems. They came up with a device that can be dabbed in the corner of the eye, absorbing a small amount of tear fluid like a wick that can then be used to measure glucose.

The major challenges are performing the test quickly, efficiently, with reproducible results, without letting the test sample evaporate and without stimulating a stress response that causes people to rub their eyes intensely.

Because of its potential impact on health care, the technology has drawn interest from BioAccel, an Arizona nonprofit that works to accelerate efforts to bring biomedical technologies to the marketplace, says a Mayo Clinic press release.

“A critical element to commercialization is the validation of technology through proof-of -concept testing,” says Nikki Corday, BioAccel business and development manager. “Positive results will help ensure that the data is available to help the research team clear the technical hurdles to commercialization.”

The researchers must now compile the proper data set to allow for approval of human testing of the device. “With funding provided by BioAccel, the research team will conduct critical experiments to determine how well the new device correlates with use of the current technology that uses blood sampling,” says Ron King, BioAccel’s chief scientific and business officer.

The results should help efforts to secure downstream funding for further development work from such sources as the National Institutes of Health and the Small Business Incentive Research Program, King says.

BioAccel will also provide assistance using a network of technical and business experts, including the New Venture Group, a business consulting team affiliated with the WP Carey School of Business at ASU under the supervision of associate professor Daniel Brooks.

Tuesday, March 15, 2011

Diabetes Management: Metformin Gets Highest Marks in New Study

The cost of managing diabetes is going up all the time. And while pharmaceutical companies are doing a great job trying to develop new drugs, the overriding profit motive is sometimes prompting them to cut corners or suppress information that may prove to me inimical to their bottom line. A case in point is Avandia, which is now banned in many countries but still prescribed in the US, but with many caveats.

However, the safety of most diabetes drugs are time-tested — insulin was discovered in the early 1920s, and two of the other most commonly prescribed, metformin and sulfonylurea, have been around since the 1950s. Indeed, these drugs have five characteristics physicians look for in diabetes medications: few potential complications, safety, tolerability, ease of use and a low cost. (See my earlier post 'Look to Older, Longer-Studied Treatments here.)

It’s not surprising that Metformin, in combination or alone, remains the top choice for first-line treatment of type 2 diabetes because it demonstrates the best risk-benefit profile vs. other diabetes drugs, according to new data.

Most importantly, the newer drugs, which have no generic options, are significantly more expensive than older ones. One hundred metformin pills cost about $35.57, or 35 cents a pill, while 30 Januvia pills (a DPP-4 inhibitor) cost $192.52, or $6.42 a pill — nearly 18 times as much. Ask any diabetic and he’ll tell you why he shudders at the thought of taking the newer medication, especially if it’s out of pocket.

According to the new study, metformin, that has been around for more than 15 years, works just as well and has fewer side effects than a half-dozen other, mostly newer and more expensive classes of medication used to control the chronic disease, new Johns Hopkins research suggests.

In their report ‒ published online March 14 in the journal Annals of Internal Medicine ‒ the Johns Hopkins team found that metformin, an oral drug first approved by the US Food and Drug Administration (FDA) in 1995, not only controlled blood sugar, but was also less likely to cause weight gain or raise cholesterol levels.

“Metformin works for most people. It’s cheaper, there’s a generic form — it’s tried and true,” says study leader Wendy L. Bennett, M.D., M.P.H., an assistant professor in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine. “Our study shows that even though there are all these newer drugs, metformin works just as well and has fewer side effects.”

The team looked at several popular classes of oral diabetes medication — metformin (sold as Glucophage, Fortamet and others), second-generation sulfonylureas (Amaryl, Glucotrol and more), thiazolidinediones (Avandia and Actos) and meglitinides (Starlix and Prandin) — and added two new classes of drugs, dipeptidyl peptidase-4 (DPP-4) inhibitors (Januvia and Onglynza) and glucagon-like peptide-1 (GLP-1) receptor agonists (Byetta and Victoza), which are given by injection.

Results indicated that most medications used as monotherapy yielded comparable decreases in HbA1c (about one absolute percentage point on average throughout the course of a study). Metformin alone, however, lowered HbA1c more than DPP-4 inhibitors alone, and any type of combination therapy reduced HbA1c by about one absolute percentage point more than monotherapy.

Weight loss with metformin was a mean 2.5 kg more vs. TZDs and sulfonylureas. Other data also showed that combination metformin and GLP-1 agonists induced greater weight loss than other combination therapies, but the researchers said evidence supporting this finding was weak.

When compared with pioglitazone, sulfonylureas and DPP-4 inhibitors, metformin also significantly lowered LDL. Further, the drug decreased triglycerides and moderately raised HDL.

The researchers reported that sulfonylureas raised the risk for hypoglycemia four-fold vs. metformin monotherapy. Combination treatment with metformin and a sulfonylurea also had a six-fold higher risk for hypoglycemia than combination metformin and TZDs.

Analysis of other adverse events revealed that risk for congestive heart failure was higher with TZDs than with sulfonylureas. Risk for bone fractures was also higher with TZDs than with metformin alone or metformin combined with sulfonylurea. Diarrhea, however, was more commonly associated with metformin than with other medications.

“Although the long-term benefits and harms of diabetes medications remain unclear, the evidence supports use of metformin as a first-line treatment agent,” the researchers wrote.

The study is an update of Hopkins research published in 2007 that also showed there were advantages to metformin. New classes of medication for adult-onset diabetes have been approved by the FDA since then, and Bennett and her colleagues wanted to know if the newer drugs were any better than the older crop.

The research team also looked for the first time at the efficacy of two-drug combinations to treat the chronic disease, which has become increasingly common with more than one-third of diabetes patients needing multiple medications.

Researchers found that while two drugs worked better than one in those patients whose blood sugar remained poorly controlled on a single medication, there were also side effects associated with adding a second medication.

“Diabetes is an enormous public health problem, and patients have difficult decisions to make about what medications they should be taking,” Bennett says. “Our study provides good information comparing drugs and can be used to inform those decisions.”

Bennett and her colleagues reviewed 166 previously published medical studies that examined the effectiveness and safety of diabetes drugs, as well as their impact on long-term outcomes including death, cardiovascular disease, kidney disease and nerve disease.

No drug or combination of drugs was shown to have an advantage in improving long-term outcomes, Bennett says, primarily because there weren’t enough long-term studies, particularly of newer medications.

While most drugs reduced blood sugar similarly, metformin was consistently associated with fewer side effects. Though metformin is associated with increased risk of gastrointestinal side effects, Bennett, an internist, says she finds many of her patients can overcome them by starting with a low dose and taking it with meals, though patients with severe kidney disease may avoid it.

The sulfonylureas and meglitinides were associated with increased risk for hypoglycemia, or dangerously low blood sugar levels. The thiazolidinediones increased risk of heart failure, weight gain and fractures. In September 2010, the FDA placed restrictions on the use of Avandia because of concerns that the drug increases the risk of heart attack.

While the drugs all reduce blood sugar levels, Bennett says more research is needed into whether they actually improve outcomes for diabetics in the long run. It remains an open question as to whether patients with type 2 diabetes who have their blood sugar controlled by medication will reduce their chances of having complications associated with the disease, including eye, kidney and nerve diseases, she says.

“Some of the drugs haven’t been on the market long enough to study the long-term effects or even some of the short-term rare side effects, so we need longer studies in patients who are at highest risk for complications” she says.

Friday, March 11, 2011

Long-Acting Drugs: Once-Monthly Exenatide Shows Promising Results in Phase 2 Trial

Long-acting diabetes drugs seem to have become the flavor of the season. After news of the successful Phase 2 trials of insulin degludec broke yesterday, newpapers reported today that Amylin Pharmaceuticals has also concluded trials of exenatide which can be taken monthly

According to reports, an experimental monthly version of Amylin’s type 2 diabetes drug exenatide worked as well as an experimental weekly version of the injected medication in a recent study.

Amylin is under pressure to get longer-term versions of exenatide onto the market to offset slowing sales of Byetta, the original twice-a-day version of the drug, which has been losing ground to longer-lasting competitors.

The weekly version, known as Bydureon, was rejected in October by FDA regulators who said they wanted new research data on how the weekly medication affects the heart. Amylin launched the study in February with plans to deliver results to the agency in the second half of this year.

In the latest test, the once-monthly version of exenatide reduced average blood-sugar levels, known as A1C, by between 1.3 percent and 1.5 percent in the Phase 2 clinical trial. Patients taking the weekly version of the drug, known as Bydureon, saw their A1C levels fall by 1.5 percent.

In the latest study, 121 patients were randomly given monthly doses of exenatide or weekly shots of Bydureon for 20 weeks. The trial was designed to measure the monthly drug’s effectiveness, safety and tolerability, the company said. The most common side effects from exenatide were headaches and nausea. The Amylin report said little about how well the monthly drug was tolerated among study participants.

The news came after another study showed that Bydureon didn’t control diabetes better thanVictoza, a commercially available once-daily injectable drug made by Novo Nordisk.

All of the drugs are part of a class of injected diabetes medications known as GLP-1 agonists that has emerged in recent years to compete with orally administered therapies.

Amylin plans to open talks with the FDA about whether they need to conduct additional Phase 2 tests on the drug or can move on to larger Phase 3 trials.

Thursday, March 10, 2011

New Ultra-Long-Acting Insulin Taken Thrice a Week Will Reduce Pain of Daily Jabs

A thrice-a-week insulin shot instead of the once-a-day shot at present could soon be a reality.

Doctors from India, Canada, US and South Africa have jointly tested the most promising new form of long- acting insulin ‒ degludec ‒ needed once every 48 hours, and found it to be as good in controlling blood sugar as the presently used insulin of choice, glargine (e.g. Lantus), which is a 24-hour shot.

This means that once in the market, the number of injections needed by a type-2 diabetic patient would be cut by half every week. It will also make insulin shots cheaper for patients. Pharma giant Novo Nordisk of Denmark, which funded the study, hopes to apply for licensing approval to market the drug in 2013.

However, the findings still need to be confirmed in another phase of research, and it's not clear how much the drug would cost if it were approved for this use. The Phase 2 trial results were published this week in the medical journal The Lancet.

Nonetheless, the findings are promising because most patients with diabetes don't want to have injections at all, if they can help it. And those who have to take them would prefer less. Moreover, each additional injection per day is a financial burden.

Announcing the results of their 16-week, phase-II trial of degludec in the medical journal Lancet, scientists said, "In this 16-week randomized trial, participants aged 18-75 years with type-2 diabetes and glycosylated hemoglobin (HbA1C) of 7-11% were enrolled and treated at 28 clinical sites in Canada, India, South Africa and US. At study end, mean HbA1c levels were much the same across treatment groups and insulin degludec provided comparable glycemic control to insulin glargine without additional adverse events. This might reduce dosing frequency due to its ultra-long action profile.”

The novel insulin releases over several days appears as effective as once-daily standard insulin in type 2 diabetes, an open-label trial found. HbA1c levels reached a similar 7.2% to 7.5% over 16 weeks whether patients got the novel insulin degludec three times a week or once daily, or standard insulin glargine (e.g. Lantus) once daily, Bernard Zinman, MD, of Mount Sinai Hospital at the University of Toronto, and colleagues reported online in The Lancet.

Adverse events, including hypoglycemia, were likewise comparable across the insulin groups in the phase II study, mirroring what Zinman initially presented at the American Diabetes Association meeting last summer.

"Insulin degludec is an ultra-long-acting insulin in clinical development. Its features suggest that the risk of hypoglycemia might be reduced and clinical effectiveness might be achievable with dosing three times a week in people with type-2 diabetes who were previously insulin-naive which could help with early initiation of and adherence to insulin treatment," the study says.

"It's an exciting new insulin, it's an ultra-long-acting insulin and the real issue is, of course, this is a small study, a proof-of-concept study, and we have to wait for the results of much larger studies to know where its place will be in a clinical setting," Zinman said in an interview. "It just has a much longer half-life, much more than 24 hours, compared to the other insulin and may provide some additional advantage."

However, Zinman said he doesn't see that three-times-per-week injections will be a common way to treat diabetes. "When you inject three times a week, the doses have to be increased so that it covers the full week, and in those circumstances, the benefits with respect to reducing the rates of hypoglycemia are not there," he said.

"Personally, I wouldn't use it that way. I would use it as once-daily insulin,” said Zinman, but he thinks if people do forget to take their insulin on occasion, this would be more forgiving. "We find people do occasionally forget their insulin, so this may — because it has a longer half-life and hangs around longer — that may be an advantage. I think we need to do studies to really see if that's the case."

However, topline results from a more recent phase III study comparing insulin degludec to insulin glargine again showed virtually identical glycemic control without a significant difference in hypoglycemia between groups.

While it had been hoped that the ultra-long-acting formulation might actually reduce hypoglycemia episodes, the chance to cut down on dosing frequency would be a valuable feature for clinical practice even without a safety or efficacy advantage over current basal insulin choices, Zinman's group suggested.

"A three-times-a-week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral anti-diabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," they wrote in the paper.

A longer dosing interval could be important in boosting adherence as well, and with less disruption to patients' lifestyle, Yogish C. Kudva, MBBS, and Ananda Basu, MBBS, both of the Mayo Clinic in Rochester, Minn., noted in an accompanying commentary.

But regardless of increasing numbers of long-acting options in diabetes treatment, lifestyle changes can't be overlooked, they urged.

"It is extremely worthwhile to remember that therapeutic lifestyle changes are inexpensive and favorable on a risk–benefit basis and need persistent re-emphasis, as is being done for the financial benefits accruing to patients from their employer and insurance by doing so," Kudva and Basu wrote in the commentary.

The proof-of-concept study by Zinman's group randomized 245 insulin-naive patients with inadequately controlled type 2 diabetes to open-label treatment at 28 centers internationally with one of the following regimens in combination with metformin:

• Insulin degludec three times a week ‒ Monday, Wednesday, and Friday evenings -- with a starting dose of 20 U per injection

• Insulin degludec in a 600 nmol/mL formulation once a day, with a starting dose of 10 U per injection

• Insulin degludec in a 900 nmol/mL formulation once a day, also at a starting dose of 10 U per injection

• Insulin glargine once a day, at a starting dose of 10 U per injection

Mean reductions in HbA1c over 16 weeks of treatment hit 1.3% to 1.5% in all the groups without significant differences among them. Nor were fasting plasma glucose concentrations any different between groups by the end of the study.

Confirmed hypoglycemia episodes of glucose falling below 55.8 mg/dL or requiring assistance occurred among 23% of patients on thrice-weekly insulin degludec or insulin glargine but 8% to 15% of those on once-daily insulin degludec. Although the difference between the highest and lowest rates was significant, the researchers noted that the 95% confidence intervals overlapped among all the between-group comparisons.

Nocturnal hypoglycemia by the same measure was uncommon, at 0% to 5% across groups, which the researchers attributed in part to the short duration of diabetes in the cohort.

However, as was pointed out at the ADA presentation of the data, the 55.8 mg/dL threshold may have missed hypoglycemia cases by the more standard 70 mg/dL criteria.

Diabetes specialist Dr. Vivian Fonseca, who chairs the endocrinology section at Tulane University Health Sciences Center, cautioned that more research is needed to determine if people who take the drug will face a higher risk of low blood sugar.

That's a major problem for people who currently take insulin medications, she said, as is the unpredictability of the drugs. "You give the same dose to the same person every day, and the next morning you get a different result," Fonseca said. "That is challenging for patients."

The researchers also reported that body weight remained stable throughout the trial for all treatment groups, and they pointed to "no apparent treatment-specific patterns or clustering of adverse events."

However, they cautioned about drawing firm conclusions on safety or efficacy based on the phase II data and noted that the open-label design used because of the different insulin-injection systems for the drugs might have impacted efforts to get glucose under control, as well as reporting of hypoglycemia and adverse events.

Dr Anoop Misra, chairman of Fortis Hospital's Centre of Excellence for Diabetes in New Delhi, India, said, "This is quite a breakthrough. For the first time, we have a ultra-long acting insulin with stable action. This will lead to lesser injections (once in two days) for the patients with good blood sugar control…Till now, all long acting insulin shots are for 24 hours."

It typically takes years for a drug to go through research and get approval from the U.S. government. The three-times-a-week degludec needs just one more phase of research, however, meaning that it could be on the market fairly soon if it's found to be effective. There's no indication of how much it would cost, although Kudva said it's fair to assume that it will be more expensive than insulin is today.

But one thing remains clear, Kudva said: "The most effective treatment for diabetes, a treatment that is worth doing throughout life, is attention to diet and exercise and working on one's weight. These are difficult to achieve, but even as every new medication comes, there's no getting away from that."

The study was sponsored by the drug maker Novo Nordisk of Denmark, and three of the paper's authors are employees of the company and own stock. Zinman, who helped design the study and obtain and interpret the data, has received fees for consultancy and honoraria for membership of advisory boards from Novo Nordisk and a number of other drug companies.

Diabetes: Is the ADA Shifting its Stance About Carbs?



Carbohydrates are a very touchy subject with diabetics. And for me at least, understanding carbs in a diabetic diet is more difficult than quantum mechanics (or double-entry accounting if you’re not a science type). Diabetologists and dieticians, too, have differing views. I found this article by LAURA DOLSON very instructive and am reproducing it here for those who may have missed it. You can find the lively discussion that followed the article’s publication here.

You may be surprised to know that for the past couple of decades, the American Diabetes Association has been sort of a cheerleader for carbs. Yes, I'm talking about the organization who's mission it is to promote education and research in ways aimed at preventing diabetes and alleviating the suffering of diabetics.

What is diabetes? It is essentially a disorder of the body's ability to process carbohydrates. This includes Type 1 and Type 2 diabetes, pre-diabetes, metabolic syndrome, insulin resistance, and all the other points on the diabetes spectrum. (The Endocrine Society suggests that anyone with a fasting blood glucose of 89 or above is at risk for damage to their health.)

In light of this, you'd think that limiting carbohydrate intake would be a priority in educating people about handling these disorders. And yet, the ADA jumped right onto the Food Pyramid bandwagon and began to advise people to get at least 55% of their calories from carbohydrate, such as in the Food Pyramid for Diabetes (see illustration above).

In 2008, they made one exception: diabetics trying to lose weight could follow a low-carb diet for up to one year; this was later loosened further to two years. But still they did not recommend a low-carb diet for health, blood sugar control, or preventing progression of the diabetes.

Now, in the March 2011 edition of the ADA magazine "Diabetes Forecast" are three rather remarkable articles. The first is called The "ADA Diet" Myth, which claims that there is no such thing as the ADA Diet! (Who else was having this hallucination?) Instead, Stephanie Duncare, director of nutrition and medical affairs for the ADA says, "For more than 15 years now, ADA has recognized that people with diabetes should eat in a way that helps them reach their blood glucose, cholesterol, blood pressure, and weight goals. For some, this means a relatively higher-carbohydrate diet, and for others, the diet may be lower in carbohydrate". Well, hallelujah to that, especially if the goal is "normal blood glucose" (normal meaning "a blood glucose level that will not cause further damage in the pancreas").

Even more bold is an article called, "Are Carbs the Enemy?" which attempts to cover the debate. They first present a sort of wimpy pro-carb stance. This section of the article has a notable absence of anything to do with science, instead relying on statements such as "Gone are the days of 'diabetic diets' that were meager and confining" and "as long as people eat less or cover their carb intake with medications, they can keep blood glucose levels in check with a healthy diet" ("healthy" in this case meaning "high-carb").

The article then goes on to describe a low-carb approach, citing Dr. Richard Bernstein. This section cites actual evidence, and makes what I think is a much stronger case for controlling blood glucose by limiting carbohydrates. The article goes on to a section on saturated fats which is much more balanced than usual, and then the normal "we don't have the long-term studies". The article concludes with the statement: "In the end, the best diet is the healthy one you're able to follow."

The only thing I would add is that people need support in making those changes, and as far as I can tell they are still leaving an awful lot up to the individual to figure it out for themselves. There has been quite a defeatist attitude coming from the organization that is supposed to be helpful - along the lines that it is asking just too much of people to cut carbs in any significant way. Are dietitians now actually going to support people in finding a diet that achieves as close to a normal blood glucose as possible? It would be a very big change if this happened any time soon.

But wait, there's more! A follow-on short piece called "Eating With Diabetes: 3 Approaches" lists the low-carb approach first, and then follows with "Moderate-Carb" and "Vegan/High-Carb". The weird thing is that the three approaches are described as "less than 10% carb", "40-50% carb" and "75% carb". What about people who normalize their blood glucose with 20% carb or 30% carb? Why not just say, "it's a spectrum disease, with a spectrum of carb that will treat it effectively"? In any case, I don't want to complain too loudly, because this is SO great to see in an ADA publication!

Now, to be sure, the ADA is not yet changing their basic stance. Nowhere on the latest update of the diabetes.org Web site is it stated that diabetics should follow a low-carb diet. On the other hand, there is no longer anything I can find that says to eat over half of calories from carbohydrate, either. The former food pyramid, as far as I can tell, has vanished, and there are several hints that low-carb eating is becoming a bona-fide option.

There are statements such as, "Understanding the effect of carbohydrate on blood glucose levels is key to managing diabetes. The carbohydrate in food makes blood glucose levels go up." Although diabetics are still advised that "a place to start is at about 45-60 grams of carbohydrate at a meal.", (yikes) it goes on to say to adjust from there. Even though this is not what most of us would call a low-carb diet, for most people it is a reduction from their previous advice.

[Side note: I also notice it doesn't actually say 45-60 g/meal is a good place to start. If that actually controls someone's blood glucose, that's great, but I would think that in the cases where it doesn't, it would be more disheartening to subsequently take more carb away. Why not start lower, and then add? Also, most likely, the person for whom this works is losing weight - a phase which doesn't last forever.]

To me this looks like the beginnings of a real change in approach from the ADA. The Titantic may actually be turning around! This could make a difference to the health of millions of people, and nothing could make me smile more than that.

By Laura Dolson/about.com
Image courtesy about.com

Wednesday, March 9, 2011

Self-Monitoring Blood Sugar: Is 'Second Drop' and Squeezing Finger to Draw Blood OK?

I’ve been regularly testing my blood sugar at home for nearly a decade now. At times when I get an error message on the glucometer (thanks to incorrect technique but more often because of insufficient blood), I never hesitate to squeeze out a second drop of blood on a fresh strip to get a “proper” reading. All the while I was blissfully unaware that both my actions are a matter of debate in Diabetes Self-Management Education (DSME) pundits.

It seems there is no general agreement regarding the use of the first or second drop of blood for glucose monitoring. The American Diabetes Association and other groups say that people should thoroughly wash and dry their hands, and then test the first drop of blood that comes from the finger. However, they do not have advice on what to do when you cannot wash your hands.

Now a new study suggests if soap and water are nowhere to be found, using the "second drop" of blood may be OK.

As for squeezing the finger, the researchers found that too much pressure did appear to interfere with accurate test results. On average, blood sugar readings were lower when people put pressure on the finger. The finding, according to the researchers, is in line with advice to avoid firm squeezing of the tested finger.

For the study, Dutch researchers at the Isala Clinics Diabetes Center at Zwolle in the Netherlands had 123 people with diabetes test their blood sugar under various conditions: after thoroughly washing and drying their hands; without hand washing; after handling fruit, which leaves sugar on the fingers; and after washing their fruity fingers.

The participants also tested their blood sugar using varying amounts of pressure to squeeze a drop of blood from the tested finger. (In general, guidelines advise against squeezing the finger too hard to get a blood drop because it may distort blood sugar readings.)

Overall, the study found, clean hands and the first drop provide the most accurate result. But compared with tests of clean hands, 11 percent of study participants had test results that were at least 10 percent off when they tested the first drop of blood from their unwashed hands. The same was true of 4 percent of study participants when they used the second drop of blood.

Based on that, the researchers recommend that people wash and dry their hands before testing, then use the first blood drop. But if they cannot wash up for some reason, it's "acceptable" to use the second drop after wiping away the first.

But what about fruity hands? In that case ‒ or whenever hands are visibly dirty ‒ a good washing is necessary, according to the researchers. They found that when study participants tested fruit-exposed hands without washing, 88 percent had blood sugar levels that were at least 10 percent off from their clean-hand readings ‒ at least when using the first drop of blood.

They fared better when using the second drop. But 11 percent still had results that differed substantially from their clean-hand measurements.

As for squeezing the finger, the researchers found anywhere from 5 to 13 percent of study participants had a significantly different blood sugar result (versus no squeezing), depending on how much pressure they put on the finger. On average, blood sugar readings were lower when people put pressure on the finger. The finding, according to the researchers, is in line with advice to avoid firm squeezing of the tested finger.

The findings are published in the early online edition of the journal Diabetes Care.

SOURCE: Diabetes Care