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Medtronic Gets FDA Approval of CGMs For Kids and Launches a New Guardian
The MiniLink REAL-Time Transmitter wirelessly transmits data collected by the glucose sensor to the monitor.
Medtronic has received FDA approval for pediatric models of both of its REAL-Time continuous glucose monitors, the MiniMed Paradigm REAL-Time System and the Guardian REAL-Time System. Previously approved only for adults, both pediatric models will be appropriate for kids ages 7-17.
Medtronic’s also just released its new Guardian REAL-Time CGM, which has a rechargeable waterproof transmitter about a third the size of the previous one. It also comes with new software that integrates meter, logbook, and CGM data so that patients can see the effect of diet, exercise, medication, and lifestyle on their blood sugar.
According to Medtronic, clinical studies have shown that CGMs can shorten low blood sugar events and lower A1c’s by up to two percentage points. The company asserts that up to 60 percent of low blood glucose events are not detected by current glucose monitoring standards.
Medtronic believes, however, that wide insurance coverage for continuous glucose monitors is still a few years off. The company plans clinical studies to demonstrate the cost effectiveness of the technology, but expects it to take two or three years before there is widespread reimbursement for the monitor.
Sources: Medtronic
Reuters
Categories: A1c Test, Blood Glucose, Blood Sugar, CGMs, Kids & Teens, Meters, Type 1 Issues
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Mar 29, 2007
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Diabetes Health
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.
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Topics
- Diabetic / Diabetes Health
- Type 1 / 1.5 Diabetes
- Type 2 Diabetes
- Blood Glucose / Sugar
- High/Low Blood Sugar / Fast Acting Glucose
- Insulin- Pumps, Pens & Syringes
- Continuous Glucose Monitors, CGM, Infusion Sets
- Type 2 Medications
- Hyperglycemia
- Hypoglycemia
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