Test Strip Recall Relion, Precision Xtra and other Abbott Strips

Aboott Laboratories has just issued a huge recall for blood testing strips which read low. The strips take too long to absorb the drop of blood.

The list of affected lots is given here:

http://www.precisionoptiuminfo.com/img/Lot-Numbers.pdf

Further information can be found here:

http://www.precisionoptiuminfo.com/EN

Here is their stated policy, though it would have been nice if they'd explained HOW to go about getting replacement strips:

Abbott Diabetes Care will replace affected strips at no charge with new product equal to the amount currently in the customer’s possession. Customers are advised to return all affected product currently in their possession. If customers have a partial package of product, Abbott Diabetes Care will provide a complete package of product as replacement.

They provide this customer care phone number:

800-448-5234

The company seems to have gone out of its way to avoid explaining on the web site how to get your replacement strips. This makes me wonder if they will try to get customers to phone and then state on a recorded line that they have not suffered any injury from the defective strips before giving recall instructions as did the makers of the defective Aviva strips I purchased.

It also looks like you are out of luck if you have already used up these defective strips. If you have been seeing lower than expected numbers while using strips made by this company treat them with caution.

 

Also of interest: End of Year Research Roundup

As I read the medical news, I bookmark many articles that aren't significant enough to form the basis of a blog post or which reinforce points I've already documented with quality research on the main Blood Sugar 101 web site. Many of these are discarded as time goes by, but when I went through the past year's accumulation, I ran into a few that I thought you might find interesting.

What I'm going to do here is give you the links to a dozen of the most interesting articles and studies I've collected over the past year, which didn't make the cut for a whole blog post but are still worth reading.

1. 90,000 years ago so called paleo humans were already eating grains. The quasi-religious belief that early humans ate a grain and starch free diet has never been well supported by actual research. Though there were a very few human societies that were eating animal-only diets in the 19th century, they lived in extreme environments with extenuating circumstances that made a broader diet impossible. This study pushes back the evidence that "hunter gatherers" ate grains and starches another 80,000 years. There are plenty of good reasons to cut down on carbs, but the diets of people living hundreds of generations before us are not among them.

2. Coronary Artery Calicification (CAC) scores explain the dismal results in the Veteran's study. The Veteran's study, which found no improvement in cardiovascular death rates with tight control and a higher level of hypos, has been used to argue that it is dangerous to lower blood sugar to normal levels. This study re-analyzed the data and found that that the lower a person's CAC score was, the more effective tight control was in preventing them from having heart attacks. It makes sense that if you wait until your arteries have mostly turned into rock, blood sugar control alone won't be be enough to save you.

3. Diabetic nerve damage in the bone marrow may be what causes diabetic retinopathy. This study suggests a fascinating new mechanism to explain how diabetic blood sugars damage organs. The bone marrow sends out stem cells to repair organs, but when the nerves in the bone marrow are damaged by blood sugar-caused neuropathy the feedback loop controlling this process breaks down. This may lead to tissue overgrowth elsewhere in the body as stem cells go where they aren't needed.

4. Bis-phenol A levels in human correlates to heart disease. This study looks at NHANES data, a lot of it, and finds the connection to be strong. Bis-phenol A is strongly associated with the risk of obesity in humans, too.

5. Bis-phenol A is found in high concentrations on retail receipts and most dollar bills. Other significant sources are canned food (which you eat any time you eat in a restaurant) because cans are lined with this plastic, too.

6. The most common Type 2 Diabetes gene TCF7L2 appears to lower the beta cell's sensitivity to normally secreted incretin hormones. This probably explains why incretin hormone drugs like Byetta work very well for some people, not at all for others.

7. The earlier metformin is started, the better off people with diabetes are. Taking metformin within 3 months of diagnosis doubled the length of time it was an effective method of controlling blood sugar. This data was gathered from a group of people eating high carb diets and maintaining blood sugar levels high enough to damage and kill their beta cells. (They had A1cs near 7%). Metformin taken with a lowered carb intake that normalizes blood sugar will stay effective even longer.

8. A disturbing round-up of neglected study data shows that statins not only are not effective for women but may increase cardiovascular risk in women. The author of this review points out that the FDA approves statins for women based on data from male-only studies and have not reviewed subsequent studies suggesting they raise cardiovascular risk for some women.

9. High maternal DDE blood levels lead to obesity in their babies after birth. DDE is another hormone-mimic organic chemical found in our environment. This is yet another explanation for the terrifying rise in childhood obesity and diabetes that has nothing to do with "lifestyle choices" unless you consider breathing and drinking polluted water "choices."

10. Metformin (in a mouse study) appears to block formation of the Tau protein associated with Alzheimers disease and several other forms of dementia. Though mouse studies are often misleading, because "diabetic" mice have a completely different genetic profile than humans with Type 2 diabetes and because mice are adapted to completely different diets than humans, we do know that people with Type 2 diabetes are less likely to get classical Alzheimer's disease than is the population at large. So it may be possible that their use of metformin may play a role. If you have a family history of classic Alzheimers (the kind characterized by amyloid deposits in the brain on autopsy) or Pick's disease, this may be another reason to take metformin. Unfortunately, people with diabetes get more vascular dementia than the population at large.

11. Hypothyroidism artificially raises A1c because of its effect on the blood cell, not necessarily because blood sugar is higher. This may explain why some people report their blood sugar improves after starting thyroid replacement therapy. If you are hypothyroid, this finding suggests you should trust your meter over your A1c.

12. More large-scale evidence that antidepressants are a significant factor causing Type 2 diabetes. The DPPT study found that over 10 years steady antidepressant use more than doubled the risk of developing diabetes except among those taking metformin.

 

Huge Metastudy: "Non Diabetic" Blood Sugars Cause "Diabetic" Retionopathy

I have already documented on my main web site data proving that blood sugar levels considerably lower than those labeled "diabetic" produce changes in the retina leading to blindness.

Now this finding has been confirmed and quantified in a meta study that looked at records of "44,623 participants aged 20 to 79 years with gradable retinal photographs" which examined the correlations between signs of retinopathy and the subjects' fasting, 2 hour glucose tolerance test, and A1c results.

Glycemic Thresholds for Diabetes-Specific Retinopathy: Implications for Diagnostic Criteria for Diabetes:The DETECT-2 Collaboration Writing group. Stephen Colagiuri et al. Diabetes Care Published online before print October 26, 2010, doi: 10.2337/dc10-1206

The conclusion of the study was this:

A narrow threshold range for diabetes-specific retinopathy was identified for FPG and HbA1c but not for 2-h PG. The combined analyses suggest that the current diabetes diagnostic level for FPG could be lowered to 6.5 mmol/L [117 mg/dl] and that an HbA1c of 6.5% is a suitable alternative diagnostic criterion.

The metastudy found that "glycemic thresholds for diabetes-specific retinopathy were observed over the range 6.4-6.8 mmol/L [115 - 122 mg/dl] for F[asting]P[lasma]G[lucose] 9.8-10.6 mmol/L [176.4 - 191 mg/dl] for 2-h PG, and 6.3-6.7% for HbA1c.

From this we can safely conclude that "diabetic" retinopathy is indeed occurring at levels significantly below those established by the American Diabetes Association as defining diabetes.

Based on this, you should consider yourself at risk for retinal damage if you have fasting blood sugar over 115 mg/dl (6.4 mmol/L) , a 2 hour glucose tolerance test reading over 176 mg/dl [9.8 mmol/L) or an A1c over 6.3%.

However, you need to assess this information in light of the fact that retinopathy is a relatively late diabetic complication. Diabetic neuropathy--the nerve damage that leads to impotence, amputation, and autonomic dysfunction which raises blood pressure etc.--starts to become more common when 2 hour glucose tolerance test values go over 140 mg/dl, though there does not appear to be a direct correlation with A1c or fasting plasma glucose at the lower end of the range.

Heart disease incidence correlates with post-meal readings over 155 mg/dl and rises in a straight line from 4.7% A1cs becoming quite significant over 6%.

The good news is that though these values correlate with significant retinopathy in populations who follow traditional medical advice, keeping your blood sugar values under these thresholds after diagnosis using the strategy you will read HERE will keep you from developing it if you don't already have it, and even if you do, long term will give you a much better outcome.

You can read more about Diabetic Retinopathy HERE.

NOTE: In case you wonder why the ADA diagnostic criteria are so much higher than the levels at which diabetic retinopathy occurs, the answer is that the ADA set their diagnostic criteria years ago using on data from a few small non-European populations (Pima Native Americans and Pacific Islanders) whose diabetes is related to different genetic profiles and follows a different pattern from those common in European populations.

They did this on purpose out of a misguided desire to avoid diagnosing people with diabetes for as long as possible and have fought hard in the intervening decades to keep these flawed diagnostic criteria even though they have all been found woefully inadequate by a ton of research.

The whole sad history of how the ADA has worked for decades to ensure that you will have developed diabetic complications long before you are diagnosed with diabetes can be read HERE.

Why You Neet to Get Copies of Your Lab Test Results

Every time you go to the lab to get tested, insist on getting a copy of the results for your own files. You (or your insurance) paid for these tests and they are legally yours, so the lab or your doctor must give you a copy if you ask.

Most doctors will only tell you about abnormal lab test results and if nothing was what they consider abnormal they may only give you either a dumbed out summary or a verbal reassurance that "everything was fine."

Just how misleading this can be is shown by stories of people whose fasting blood sugar was 124 mg/dl who were told they were "fine", when one more mg/dl would have been enough to diagnose diabetes.

I experienced something similar. I was told my calcium values were fine when the normal range went up to 10.3 mg/dl and my reading was 10.3. Subsequent research turned up the fact that the high end of the "normal" range for blood calcium is associated with a significantly raised risk for heart disease.

As it was likely my raised blood calcium was due to overdoing my Vitamin D supplementation (which is a growing problem given the hype about this latest cure-all supplement) I stopped the supplementation since my blood Vitamin D level was far above the level defined anywhere as deficient and in another few months the blood calcium level had dropped to the middle of the range which is much less likely to cause serious health problems.

Keeping copies of truly normal lab results can also be important, because over time you may see a trend upward that points to a developing problem. If your "normal fasting blood sugar" each year was 75, 80, 85, 90, 95, 97, and 99 mg/dl these values would all be normal, but point to significant deterioration in your fasting blood sugar control. You'd end up a lot better off if you cut back on your carb intake while still normal than if you waited until it reached 101 mg/dl and you were officially told you were "pre-diabetic."

When you keep the actual copies of your lab tests you will also be able to tell if the doctor has actually done the right tests to determine what is wrong with you. For example, if you come from a family where many relatives have diabetes and have been relying on your doctor's assurance that you don't, it would be helpful to know whether he based this assurance on the fasting glucose test, the A1c, or a random glucose test.

If you are experiencing tingling in your extremities, your doctor should order a Vitamin B-12 test as Vitamin B-12 deficiency can look exactly like diabetic neuropathy and if not treated can cause permanent nerve damage. If you are taking metformin which can in some people cause problems with Vitamin B12 absorption and suddenly develop neuropathy while maintaining normal blood sugars, it is very important to ensure this test has been done.

If your doctor tells you that your cholesterol is too high, it is important to see whether this was based on a total cholesterol number alone, or took into consideration the readings for HDL and Trigycerides which are far more predictive of trouble.

Over the years, diagnostic standards change. This is another reason old lab tests may provide you with useful information years later. When I first ran into problems with my blood sugar, the definition of diabetes was a fasting blood sugar of 140 mg/dl. The cutoff subsequently dropped to 125 mg/dl.

A person who had been assured they weren't diabetic in 1996 based on the old standard might get more insight into why they already had diabetic complications like neuropathy or protein in urine the very day they were diagnosed with diabetes in 2000 if old copies of their fasting blood sugar tests showed they had been in the 130s consistently over the previous decade.

Another reason you want to hold on to your lab test sheets is that for many tests the range that defines normal varies from lab to lab and is not standardized. Labs also use different units for reporting test results. One of the big problems with Vitamin D recommendations is that labs use two different units for reporting blood levels of Vitamin D and people often assume they are deficient because they are looking at recommendations that are given using a unit that is not the one that their lab uses. Only your lab sheet will tell you what unit your lab used.

Insulin and C-peptide analysis are not standardized and and the lab reference ranges are different from lab to lab. Even the same hospital may send your blood draw out to different vendors for analysis so that the reference range will vary from year to year though you go to the same hospital lab. The reference range is essential for interpreting the result and when a test is not standardized, as is the case with insulin and C-peptide you can't compare your readings with those of others who use other labs.

There is another reason why you need to get copies of your test results right after you go to the lab. As I learned the hard way, after a few years it may be impossible to retrieve older lab results from the lab or your doctor.

Hospital labs do not keep results online for more than a few years. They are continually changing their computer systems and each time they make a change they get rid of old data. I found one set of labs impossible to retrieve from a local hospital only 3 years after they were done.

Doctors will have your old labs in their records, but you will lose access to those if you move to a new doctor. Even when you ask your old doctor to forward your medical records to the new doctor, what actually happens is that the doctor is sent a summary sheet not the actual records, which are put in storage somewhere and can be difficult or impossible to access if you need them.

If your doctor retires or moves to a new practice there may also be a brief period during which you can get your records, after which they may become impossible to retrieve.

When you get your lab tests you will often see values flagged as high that your doctor has not mentioned. The most common of these is the BUN which is often elevated in people who are eating a low carb diet because the low carb diet induces a degree of dehydration that affects the test result but does not cause any health problems. If you see a value on your lab sheet that concerns you, ask your doctor about it. There are also sites on the internet that explain the various test results and what they mean.

If you are paying for your lab tests as too many of us are, keeping copies of old tests can help you avoid unnecessary tests. If a doctor routinely schedules certain tests which you have long had normal values for, feel free to ask what the point of the testing might be.

All too often, the point of the test is to allow the doctor to qualify for some benefit to himself from imbecilic insurance-company sponsored programs that judge the quality of medical care by how many patients are given total cholesterol tests or quarterly A1c tests (irrespective of the value the tests show.)

If there is no health problem you need to diagnose or medication change you might make based on the result, there is no reason to pay for expensive testing.

When you go to a lab ask the person who does the test what the procedure is at that lab for getting your results. Some labs will give you the results as soon as they are ready if you show a driver's license. Others require you to fill out a form and will mail them to you.

It is helpful to get the results before your doctor's appointment so that you can discuss any issue you find in them. However, if you don't get a copy before the appointment, you can always ask the doctor to have a copy made at the front desk and can take that copy home with you.