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FDA approves first artificial pancreas system with threshold suspension
The FDA approved a landmark artificial pancreas system with automatic threshold suspension for patients aged at least 16 years with diabetes, according to a press release. The system is the first of its kind, approved under the new FDA product classification, “OZO: Artificial Pancreas Device System, Threshold Suspend.”
MiniMed 530G with Enlite (Medtronic) has the capability to halt insulin when the Enlite sensor detects glucose has reached preset values (60 mg/dL-90 mg/dL) and when the patient does not respond to the threshold alarm, according to the press release.
Another benefit of the device is its ability to suspend delivery for 2 hours if a patient is sleeping, unconscious or otherwise unable to respond.
“The diabetes community has eagerly awaited approval of this system that stops insulin delivery when sensor glucose values fall below a predetermined threshold,” Richard M. Bergenstal, MD, executive director of the International Diabetes Center at Park Nicollet Health Services in Minneapolis and clinical professor for the department of medicine at the University of Minnesota, said in the press release. “We are hopeful that advances such as this and improvements in the accuracy of continuous glucose sensors will help people with diabetes strive for better control of their diabetes.”
Besides the post-approval study including children aged at least 2 years, the manufacturer will also participate in patient follow-up to ensure safe use, as requested by the FDA.
For more information:
FDA. Types of artificial pancreas device system.
Medtronic. MiniMed 530G with Enlite.
Perspective
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The device represents a useful option for patients with type 1 diabetes who may have hypoglycemia, particularly during the night, without being aware of this. Not infrequently, however, patients still report difficulty with calibration of the sensor leading to glucose results that do not agree with the capillary blood sugar. Although in general, the new device performs very well. Studies conducted in clinical trial settings certainly show that low glucose suspend works, and in Europe, the low-glucose suspend has been used extensively and appears effective. There are certainly patients for whom it’s appropriate. However, we have to be cognizant of the fact that patients continue to be upset when a reading on the sensor does not correspond to the simultaneously measured capillary glucose level.