Medtronic is a step closer to developing an automated artificial pancreas for diabetics, as study results show the Threshold Suspend feature of its sensor-augmented insulin pump reduces nocturnal hypoglycemia without impacting the glycated hemoglobin level (HbA1C).
An automated insulin pump feature in investigational MiniMed integrated system, Threshold Suspend temporarily stops delivery of insulin once the sensor glucose value goes beyond a pre-set low level.
When the threshold is met, the insulin pump will raise the alarm and stop insulin delivery for two hours.
The ASPIRE In-Home study, which secured investigational device exemption (IDE) from the US Food and Drug Administration, compared two MiniMed sensor-augmented insulin pumps with continuous glucose monitoring - one which incorporated the Threshold Suspend feature and one without.
About 247 patients with type one diabetes and documented nocturnal hypoglycemia were randomly selected for a sensor-augmented insulin-pump therapy - about 121 were given with Threshold Suspend feature, while the remaining were given therapy without it, for a period of three months.
The MiniMed sensor-augmented insulin pump with the Threshold feature showed positive results.
Hypoglycemia can be fatal for people suffering with diabetes, especially at night when patients are least aware of the symptoms as they sleep.
Medtronic Diabetes Business global medical affairs vice president Dr. Francine Kaufman noted ASPIRE In-Home met both its safety and efficacy endpoints and provides additional clinical validation for Threshold Suspend.
"The study results are important as we continue to move toward our goal of developing a fully automated system, or artificial pancreas that will one day require very minimal interaction from the patient," Kaufman added.
The Threshold Suspend feature is available internationally in the MiniMed Veo System and is also a part of the MiniMed 530G, which currently is not commercially available in the US as it under an FDA review.
The MiniMed 530G system has been submitted for approval under FDA's new product classification, called OZO: Artificial Pancreas Device System, Threshold Suspend.
Image: MiniMed Paradigm REAL-Time Revel System. Photo courtesy of Medtronic.