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Insulin Pump with Low Glucose Detection Now Approved

FDA approves the first US insulin pump with low glucose suspend feature…. 

Medtronic, maker of several products for diabetic patients, recently received FDA approval for a new type of insulin pump. With a new product classification as the first "OZO: Artificial Pancreas Device System, Threshold Suspend," the MiniMed 530G with Enlite provides a feature that holds insulin delivery when the glucose sensor detects a blood sugar between 60-90 mg/dL and the patient initially fails to respond to the alarm. This sensor feature is 31% more accurate and can detect up to 93% of hypoglycemic episodes.

Currently, the device is approved for use by patients who are 16 years of age and older; however, use by patients 2 years of age and older is likely to be sought. Another device available from Medtronic that is similar to the Enlite, but is not available in the US, is the Paradigm Veo. This machine also has the low glucose suspend feature and can be used by children and adults and has been shown to reduce severe hypoglycemia, including nocturnal hypoglycemia.

The MiniMed 530G, which will be available in the next several weeks, introduces a key concept in providing patients with fully automated glycemic control using the suspend feature once low glucose is detected by the machine. In addition to the new feature, the device is also 69% smaller than the previous version.

Practice Pearls:
  • Medtronic receives FDA approval for insulin pump with suspend feature
  • Approved for use of patients 16 years of age and older with diabetes
  • Introduces key concept for detecting hypoglycemic episodes
FDA, Oct. 2013