TUESDAY, July 8, 2003 (HealthDayNews) -- A new device that combines a glucose-testing meter and an insulin pump to both monitor and remedy a diabetic's high or low blood-sugar levels has been approved by the U.S. Food and Drug Administration.
As is the case now, patients will still have to prick their fingers to draw blood. But the combination device -- including its sophisticated software -- takes over from there. It calculates and transmits how much insulin is needed to the insulin pump, which then supplies the needed amount to the patient. The FDA says this can prevent errors that sometimes result when a patient calculates the amount of insulin needed and inputs the information to the pump manually.
The Paradigm device is co-manufactured by Medtronic MiniMed, which makes the insulin pump, and by Becton Dickinson, which produces the glucose monitor. The FDA says it cleared the device based on reliability of the separately produced components, and usability studies and compatibility testing information supplied by both firms.
More than 4 million American diabetics use insulin to control blood sugar levels, Medtronic says. Blood sugar fluctuations can cause loss of consciousness, and long-term complications including blindness, kidney failure, heart disease and death.
For more information, check this FDA Talk Paper. To learn more about diabetes, visit the National Institute of Diabetes and Digestive and Kidney Diseases.