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Are All Home-Based Blood Sugar Tests Equal?

FDA takes steps to eliminate potential risks for people with diabetes


However, the accuracy goal refers to numbers achieved prior to device approval. Once the machines and test strips are on the market, Lias noted, the FDA relies on after-market complaints to the manufacturer, which are supposed to be shared with the FDA, as well as complaints sent directly to the FDA, outreach to the clinical community and FDA inspections.

Some of that feedback to the FDA may be coming from a new campaign, called Strip Safely, started by Bennet Dunlap, a father with two teenagers with type 1 diabetes.

"I was pretty frustrated when I heard that there were blood glucose monitoring systems (devices and test strips) that failed to even meet the 20 percent standard," Dunlap said. In response, he created the Strip Safely campaign to "try to create a call to action for the FDA by the diabetes community."

Dunlap said he wants to be sure that the FDA uses its power to recall faulty diabetes equipment in much the same way that it polices other products.

"The FDA recently recalled cilantro because it contained a risk of 'serious or potentially fatal infections,' according to their press release," he said. "Well, faulty test strips can cause serious and potentially fatal injections [of insulin] in people with diabetes."

The most serious risk from a faulty blood sugar test is that someone with type 1 diabetes (an autoimmune disorder that always requires insulin treatment) or someone with type 2 diabetes who uses insulin could give themselves too little or too much insulin. The most immediate danger would be from too much insulin, which can cause hypoglycemia, or low blood sugar levels. Hypoglycemia causes troubling symptoms, such as shakiness, sweating and confusion, and if left untreated, can cause someone to pass out or even die. Too little insulin results in hyperglycemia, or high blood sugar. Over time, hyperglycemia can lead to such complications as kidney disease and vision problems.

Dr. David Simmons is chief medical officer of Bayer HealthCare's Diabetes Care, in Tarrytown, N.Y. He said: "People should understand that every time you do a blood sugar test, it's an experiment, and the results have a range. Even tests done in a lab have ranges. Bayer takes accuracy standards very seriously and aimed for a substantial improvement in our new line of meters." He said that 99 to 100 percent of Bayer's new meters meet the 20 percent guideline and about 98 percent meet the 15 percent guideline.

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If the level is below 70 or you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.

People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.

Congratulations on taking steps to manage your health.

However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.

Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

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