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How do I check the precision and accuracy of my blood glucose meter?

By Richard K Bernstein 1 years ago 1780 Views No comments

You can check the precision of your blood sugar meter and even possibly the accuracy.

Here's the method Dr. Richard Bernstein uses to enable you to check the precision (reproducible results) of your blood sugar meter and even possibly the accuracy.

As you probably know, most of the blood sugar meters on the market, according to studies that have already been published, are grossly inaccurate. I see the best accuracy, especially around normal values – so I consider normal values around 80, except with children, in the 70s, and how do you do that? Well, one could say, “Let's look at the control solutions or test solutions that the manufacturers provide with their meters.” The trouble is that, nowadays, most of the manufacturers are not providing normal controls – it has to do with some FDA guidelines that don't make sense and they're doing the minimum that they have to do to comply with FDA regulations – so they usually have control solutions that would read somewhere around 30 or 40 milligrams per deciliter, on the one end, and another solution that would read around 300 milligrams per deciliter. Now how do you now, measure for accuracy? I'm not interested in precise accuracy at a blood sugar of 30 or at a blood sugar of 300; I want it accurate where most of my patients' blood sugars are, which would be, let's say, between 80 and 100.

So how do I get this, and how do I go about testing? Well, what we do is we get hold of the manufacturer's control solutions to a meter, and we use 3 parts of the low control, which might be 30 or 40, as the middle of the range, and 1 part of the high control, and we put them in a little plastic squeeze bottle or in a glass dropper bottle that has a tight seal 'cause you don't want evaporation – evaporation will make the concentration of glucose go up – and this mixture will have a blood sugar of somewhere around 100 – it might be 108; it might be 113; it might be 97 – and you could calculate what that value would be by taking the middle value of the low control – so let's say the low control is 30 to 70: you can get the middle value by adding 30 and 70 and dividing by 2, and you get 50. And if the high control is 200 to 400, the middle value would be 300, so we would take 3 parts of the low control, so 3 times 50 would be 150, and we'd add in 1 high control, which would be 300, so that adds up to 450, and we've taken a total of 4 samples, 3 and 1, so we divide 450 by 4 and you get something like 112. So this solution should read at 112 milligrams per deciliter. So if the solution is accurate, if the manufacturer's provided you with accurate control solutions, then it's a good test of the accuracy of the meter – it should read that value that I just told you, of 112.

Now, just as important or more important, is the precision or reproducible results. What if you did 10 tests in a row, would they all read 104? And what we find, with most of these meters, is that they're scattered over a wide range. In fact, we found that one of the most popular-selling meters, a meter that many of the insurance companies require for diabetics, instead of the most accurate one, reads chronically low and may read very low or very haphazardly. So that particular meter, you might think you're going to get a reading of 104, and you get a 160 or you get 50 – that's how wide a range of readings you get with some meters – and, therefore, you do 5 or 10 tests in a row, you get a load of different numbers. On other meters, like the one that we recommend and we've mentioned it before, we get the same value over and over and over again, plus or minus one or two milligram per deciliter. So that shows consistency. And then if our reading is almost on the nose with the value of our control solution, we can be fairly confident of the accuracy, but we're assuming that the manufacturer made accurate control solutions. So the only way to be absolutely sure of the accuracy is to do a blood sugar at the clinical lab, while they're drawing blood from your arm, and see how it compares.

​What is a normal fasting blood sugar?

By Samuel Kolodney 1 years ago 825 Views No comments

There is a lot of information about “normal” blood sugar levels floating around the internet from many sources but the science paints a clear picture that isn’t always described by the various recommendations.

I find it interesting that the American Diabetes Association, along with other reputable organizations, suggests blood glucose level targets for most nonpregnant adults with diabetes that do not account for the relative risks of higher blood sugars. An example of this is the ADA recommendation of a fasting blood sugar of between 80–130 mg/dl. You can see the recommendation at this link

This number leaves out mention of a study published on another ADA website that concludes:

Fasting blood glucose values in the upper normal range appears to be an important independent predictor of cardiovascular death in nondiabetic apparently healthy middle-aged men.

More importantly, the study describes the “upper normal range” as being above 85mg/dl.

You can read an abstract of the study for yourself here.

The question that immediately comes to my mind is why do the suggested numbers in this recommendation skew dangerously high? The facts contained in the study clearly point to the need to keep fasting blood sugars below 85. In fact, Dr. Richard K. Bernstein maintains his blood sugar at 83 mg/dl and as a type 1 diabetic has kept them there for the last 50 years. He is now 82 years old and has no complications commonly associated with diabetes.

The research shows the optimal fasting blood sugar is between 80-84 mg/dl

Dr. Bernstein details how to achieve normal blood sugars in his best-selling book Diabetes Solution. Learn more at: www.diabetes-book.com

The Need to Test for Loss of Protective Sensation

By Peter Allton, DPodM 1 years ago 943 Views No comments

A podiatrist's perspective on reducing amputations due to diabetic foot ulcers

As a podiatrist with 28 years of experience, my personal passion fits in very well with what Medipin has to offer and in fact, in my book Undefeeted by diabetes, which is the spearhead of our award winning not for profit organization- Undefeeted, I cite a need for such a device to test for Loss of Protective Sensation (LOPS) when at the time of writing I was unaware of Medipin.

Medipin can help reduce amputations from diabetic neuropathy in a number of ways:

1) As a practicing Podiatrist I regularly come across patients who, although they can feel a monofilament, are unable to detect the sharpness of a neurotip pinprick (a test usually omitted from diabetic screening appointments here in the UK) These people are often unaware going forward of their level of risk of not feeling a wound that then gets no care and becomes infected.

2) Out of 194 countries only 60 of them (give or take) have Podiatrists. For people in these other countries Medipin offers a safe way to test themselves so they can be empowered by knowing their risk status.

3) Once they know their risk, they can act appropriately by altering their behavior to minimize a wound developing or in the event of a wound would be alerted to contacting a physician or attending a clinic to thoroughly diagnose the risk and obtain prophylactic treatment to prevent foot ulcers from developing.

4) Even if they can feel the pinprick sensation when they use the Medipin, there is still the benefit that they are paying attention to their feet. It has been my experience that anything that reminds patients of the importance of maintaining healthy feet and the vulnerability they have to neuropathy has to be a plus.

Undefeeted.org is passionate about helping the USA to win the battle against amputations. It is our vision that every country in the world can cut their amputation rate by 2/3rds by the year 2035 so that globally the rate will be reduced from 1 every 20 seconds to 1 a minute. In the USA, with proper awareness, the number of amputations would fall from 200 a day to around 66 a day.

Medipin is an FDA listed, all-plastic precision instrument designed to avoid skin puncture while significantly heightening pinprick sensation at lower application pressures by exploiting neural lateral inhibition. To accomplish this, a specially faceted and blunted point is situated within a surrounding annular component that serves to both micro stretch the skin and create an artificial center surround field.

The best way to detect early onset of diabetic peripheral neuropathy

By Barry L. Jacobs D.O. 1 years ago 2396 Views No comments

In Diabetic Peripheral Neuropathy (DPN) cutaneous pinprick sensation deteriorates early and gradually over time. Therefore, as a testing modality, it can be exploited for both sensitivity and if the technique is correct, for subtle specificity.

Continuous Pinprick Comparison (CPC) is far better than conventional pinprick technique because the latter only utilizes a binary response. ‘All or nothing’ is bound to provide many false negative results because sensory loss is incremental. The patient is asked only IF they can feel the sensation and not to rate HOW MUCH they feel it.

If a comparative, analogue scale is introduced, the technique is able to demonstrate subtle loss of sensation by degree. This will enable the detection of sensation deficit by pinprick testing to precede other modalities and more accurately reflect progress of deficit.

The provision of an analogue scale then affords the facility to more reliably predict patients at risk of complication and facilitate cost effective management.

How To Do It

In the past pinprick sensation testing has been dismissed clinically because it is typically used only in a binary, "on or off" fashion which produces largely false negative results. Essentially, where pinprick perception has diminished, patients can still report a stimulus though there is no facility to express magnitude. In consequence pinprick appears insensitive to neuropathy by virtue of it being applied to the wrong question.

If the technique is modified to employ a continuous repetitive comparison with a control area of skin, effectively unaffected by pathology, whilst asking the patient to express their sensitivity in the affected area on a simple scale of 1-5 (where "normal" is 5) it is possible to establish a subtle analogue scale from verbal feedback.

When a different observer/operator repeats the procedure on the same subject it is a simple matter to re-establish the new ‘5’. Furthermore intra and inter-operator test reliability can be significantly facilitated by use of a rapid repetitive application technique to iron out random variations in application pressure and nociceptor distribution.

In short pinprick is often the first sensation to be lost (sensitivity) and the most easily assessed accurately (specificity) providing the correct technique is employed.

Below is a table of modalities and their strengths in detecting neuropathy.

Modality

Vibration

Temperature

Monofilament

Pinprick

Ease of application in primary care Setting

Easy

Difficult

Easy

Easy

Sensitivity

Very Sensitive in the young

(Goes Early)

Very Sensitive in the young

(Goes Early)

Very insensitive (Goes late)

Very Sensitive in all age groups (Goes early)

Specificity

Very Unspecific

absent in middle stages and physiologically less sensitive in the elderly

Very specific in the young

and physiologically less sensitive in the elderly

Very Specific but only to crude/late loss

Very Specific with CPC as caters to an analogue/

Predictive scale

Inter & Intra Observer /Operator Reliability

Not Very reliable due to inter-operator error in application

Not very reliable due to accuracy of equipment

Very reliable with new instrument

Very reliable with CPC

Proven by North West Study nearly 10,000 patient cohort and crude test

Abbott et al, 2002, The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort 2002 Diabetes UK. Diabetic Medicine, 19, 377–384

Medipin is an FDA listed, all-plastic precision instrument which was designed to avoid skin puncture whilst, simultaneously, significantly heightening stimulation at lower application pressures by exploiting the phenomenon of neural lateral inhibition. A specially faceted and blunted point is situated within a surrounding annular component that serves to both micro stretch the skin and create an artificial center surround field.

Find more about Medipin for Home Self-Care

Learn more about Medipin for Clinical Care

ADA Recommends Pinprick Test for Asymptomatic Diabetic Neuropathy

By Barry L. Jacobs D.O. 1 years ago 556 Views No comments

With the release of the ADA’s new guidelines for 2017, there is much attention focused on early diagnosis of diabetic neuropathy or symmetrical neuropathy and that subtle signs of loss of pinprick or temperature sensation are important signals to implement appropriate management. But, there is still some confusion as to what might constitute Loss of Protective Sensation (LOPS).

In its annual position statements the American Diabetes Association often describes LOPS as if it were exclusively synonymous with failure to feel light touch. However, since the ADA's new 2017 guidelines acknowledge that pinprick is likely to be the first modality to be lost in diabetic neuropathic degeneration, due to the vulnerability of its small constituent fibers, then rather than light touch we primarily need to address the loss of the patients’ capacity to detect pain and other potentially harmful stimuli.

Essentially pain is a protective mechanism. That is precisely what it is for. This is the very implication of the term “The Gift of Pain” as forms the eponymous title in the well know volume (Brand P, Yancey P. Zondervan. Reprint edition September 1, 1997)
. In particular, this book was influenced much by the effect of Hansen’s disease (formerly known as leprosy) to cause neuropathy and loss of protective sensation leading to serious complications. If a patient fails to feel that they are treading on a shard of glass, which can penetrate their skin, then certainly they are vulnerable to damage. It is important to note that, unlike light touch, pain sensation is there to protect and does not permit habituation. We rapidly become used to the sensation of long hair or clothes on our skin but not to painful, noxious feelings that can be caused by encounters with objects that can harm or penetrate the skin. Light touch neither warns us against damage nor diminishes early on in the neuropathic process. Therefore, the Gift of pain is to protect us and pinprick is a remarkably valuable test for this. Loss of pain IS loss of protective sensation.

Medipin is a precision device that provides consistent pinprick sensation testing while shielding and inhibiting penetration of the point

Learn more about Medipin for Clinical Care

Test for Diabetic Neuropathy

By Samuel Kolodney 2 years ago 748 Views No comments

Diabetic neuropathy when gone unchecked can have devastating consequences including ulcerative wounds and even limb amputation. Improvement in the rates of self-care and home testing for diabetic neuropathy can have a dramatic impact on individual health outcomes.

Pinprick sensation testing using the technique recommended in the ADA's guidelines to detect diabetic neuropathy and when performed with a Medipin, it is probably the easiest test for patients to do in the home.

Why Use Medipin?

The optimal pinprick test generates as acute a sense of sharpness as possible without increasing the risk of skin penetration. For decades, since the work of the likes of De Castillo, Katz, Miledi and others, we have understood the neurophysiology of these stimuli. Pinprick is not truly about physical sharpness at all. A hypodermic needle is very sharp – a blade really – and as such and in the right hands can be almost painless. On the other hand, sharp stimulation acuity is all about skin stretch and contact demarcation of the point and its surfaces of contact.

Medipin is an FDA listed, dedicated device which has been in regular use by US Doctors for many years, as well has having been employed successfully in quite a number of international medical studies. It utilizes a well demarcated but blunted pyramidal point in order to exploit the stretching phenomenon. As well as being intended to reduce the risk of skin penetration this stretching actually heightens the sense of pinprick. This heightened sensation is then augmented by the surrounding annulus in which the point is situated that creates a perimeter of duller sensation to exploit the cortical phenomenon of lateral neural inhibition.

Lateral inhibition, is the phenomenon that suppresses information form areas of perception bordering those that more vividly garner cortical stimulation to evoke discrete boundaries and delineations. This is the same phenomenon that fools us in optical illusions and is leveraged here by positioning Medipin’s well demarcated point at the center of an area of duller stimulation created by the annulus. Effectively the Medipin device generates the perception a localized center surround field effect which further enhances the sharp element at its’ center whilst surrounding neurons are inhibited to further augment perception of the point. This tricks the brain in to perceiving greater pain than the stimulus would otherwise warrant.

This means more acute stimulation at lesser contact pressure. Or, in layman’s terms more pain sensation with no actual harm.

Learn more about Medipin for home self-care testing

The gift nobody wants but everybody needs?

By Samuel Kolodney 2 years ago 668 Views No comments

The Gift of Pain.

The gift of pain is what keeps our bodies healthy. Without it we can unknowingly harm ourselves. People with Diabetes are susceptible to losing the gift of pain through a condition called Diabetic Peripheral Neuropathy (DPN), which is a form of nerve damage.

Diabetes is a leading cause of peripheral neuropathy in the United States. The National Institute of Health estimates between 60 to 70 percent of people with diabetes have mild to severe forms of nerve damage that can affect sensory, motor, and autonomic nerves and present with varied symptoms.1

One of these symptoms is the Loss of Pain Sensation, which may lead to foot ulceration due to even minor trauma. As many as 25% of people with diabetes develop at least one foot ulcer during their lifetime. Studies also suggest that between 4 and 10 per 1000 people with diabetes will have a lower limb amputation.2

According to the American Diabetes association in 2010, about 73,000 non-traumatic lower-limb amputations were performed in adults aged 20 years or older with diagnosed diabetes.3

Data collected by Southern California Kaiser Permanente between 2008 and 2011 shows that the rate of lower limb amputations drop as the number of foot exams increase. The difference was significant, which improved from a country wide average of 2.2 amputations per 1000 people to 0.79 amputations per 1000 people for those undergoing regular foot exams.4

What can be done to reduce the incidents of diabetic foot ulcer and amputation?
Medipin diabetic toes test makes it easier, safer, and more convenient than ever to perform monthly self-testing for loss of pain sensation.

Learn more about Medipin:
https://www.doctorsoption.com/medipin-the-diabetic...


References:

1 Peripheral Neuropathy Fact Sheet

http://www.ninds.nih.gov/disorders/peripheralneuro...

2. Singh N, Armstrong DG, Lipsky BA. “Preventing foot ulcers in patients with diabetes.” JAMA.2005;293:217–28.
http://www.ncbi.nlm.nih.gov/pubmed/15644549

3. American Diabetes Association. “Statistics About Diabetes”
http://www.diabetes.org/diabetes-basics/statistics...

4. Lee- Reducing Amputation Rates - HealthConnect Strategies
https://www.signup4.net/Upload/KAIS13A/PHYE362E/Le...

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