FDA OKs Insulin Pump With Low-Glucose Suspend Feature

Miriam E. Tucker

Disclosures

September 27, 2013

In a move long awaited by the US type 1 diabetes community, the US Food and Drug Administration (FDA) has approved a Medtronic sensor-augmented insulin pump system that includes a low-glucose suspend safety feature.

The MiniMed 530G with Enlite is the first system licensed in the United States in which the pump automatically stops insulin delivery when the continuous glucose sensor (the "Enlite") detects that the patient's blood sugar has fallen below a preset threshold (60 - 90 mg/dL) and after the patient fails to respond to an initial alarm. A similar system also manufactured by Medtronic (Paradigm Veo) has been available in many other countries since 2009.

The device is the first system approved under the new product classification, OZO: Artificial Pancreas Device System, Threshold Suspend, created by the FDA, according to a Medtronic statement.

The device was approved for use by people with diabetes aged 16 years and older, but Medtronic is planning to conduct a postapproval study including children aged 2 years and older.

In a randomized trial published September 25, the Paradigm Veo was shown to reduce severe hypoglycemia among patients with type 1 diabetes who have hypoglycemic unawareness, and a larger study published earlier this year found significant reductions in nocturnal hypoglycemia with the same device.

According to Medtronic, the Enlite is 31% more accurate than previous-generation sensors, detecting up to 93% of hypoglycemia episodes. The new sensor is also 69% smaller and simpler to insert.

The product is expected to launch "in the next several weeks."

The low-glucose suspend feature is considered a key step in the technologic progression toward a fully automated "artificial pancreas" system, which monitors the patient's glucose levels and delivers the appropriate amount of insulin with no input required from the patient. That's coming next, Medtronic says.

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