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FDA OKs Insulin Pump Plus Glucose Monitor System

New Diabetes System Tracks Blood Sugar, Offers Small Insulin Doses
By
WebMD Health News
Reviewed by Laura J. Martin, MD

fda_oks_diabetes_system.jpg

March 17, 2010 - The FDA has approved Medtronic's new diabetes management system, which takes patients one step closer to the elusive goal of an artificial pancreas.

The new MiniMed Paradigm REAL-Time Revel System does not entirely close the loop between glucose monitoring and insulin treatment. Patients still have to confirm the device's warning with a finger-stick blood sugar measurement.

But the monitor predicts dangerously low or high blood sugar levels. And the pump allows patients to administer insulin in very low increments -- as low as 1/40 of a unit per hour -- a useful feature for children or other people who are sensitive to insulin.

Moreover, the system comes with a device that plugs into a computer's USB port and wirelessly uploads information from the insulin pump and glucose monitor. Web-based software helps patients keep close track of their blood sugar control.

In a recent Medtronic study, the new system improved detection of low-blood-sugar events by nearly 36%, while only very slightly decreasing (by 4%) detection of high-blood-sugar events.

In a Medtronic news release, William Tamborlane, MD, chief of pediatric endocrinology at Yale Medical School, says that linking an insulin pump to a continuous glucose monitor improves diabetes patients' blood sugar control while reducing the risk of blood sugar crashes.

"Advances such as predictive alerts and smaller [insulin] delivery rates can help physicians and patients customize therapy to meet individual needs. This ultimately simplifies some of the complexity of daily diabetes management."

Medtronic says the system is immediately available to patients.

The retail price of the system is $6,500, but Medtronic says some 90% of type 1 diabetes patients with commercial insurance coverage who have a medical indication for the device will be reimbursed. A Medtronic spokesperson tells WebMD that the out-of-pocket costs for such patients is between $500 and $1,200.

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Your level is currently NormalHigh (hyperglycemia).Low (hypoglycemia).

If the level is below 70 and 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.

If the level is below 70 and 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.

Your blood sugar level is slightly high. You should call your health care provider and ask if laboratory tests to check for diabetes are needed. 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 currently normal. However, if you are concerned about diabetes speak with your physician. There may be other risk factors that increase your risk for diabetes.

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.

Your blood sugar level may be high, depending on when you last ate. If you have not eaten for at least 8 hours, your blood sugar should be less than 100. If you've eaten within the last 2 hours, your blood sugar should be less than 140. You should call your health care provider and ask if you need laboratory tests to check for diabetes. If you are pregnant always consult with your health care provider.

Blood sugars consistently above 180 warrant prompt medical attention.

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.

Your blood sugar level is high. You should call your health care provider and ask if laboratory tests to check for diabetes are needed. If you are pregnant always consult with your health care provider.

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