US-based Medtronic's sensor-augmented insulin pump with Threshold Suspend feature safely reduces nocturnal hypoglycemia without affecting glycated hemoglobin level (HbA1C), a study results show.
Threshold Suspend, which is claimed to be the first-of-its-kind automated insulin pump feature and unique to an investigational MiniMed integrated system, automatically suspends delivery of insulin temporarily when sensor glucose values reach a pre-set low level.
Once the threshold is met, the insulin pump raises alarm and suspends insulin delivery for two hours.
The ASPIRE In-Home study, which received investigational device exemption (IDE) from the US Food and Drug Administration, compared two MiniMed sensor-augmented insulin pumps with continuous glucose monitoring - one with the Threshold feature and one without it.
About 247 patients with type 1 diabetes and documented nocturnal hypoglycemia were randomly chosen for a sensor-augmented insulin-pump therapy.
About 121 patients were given with Threshold Suspend feature while the remaining were given without it for a period of three months.
The MiniMed sensor-augmented insulin pump with the Threshold feature had shown positive results as against the one without this feature.
Medtronic Diabetes Business global medical affairs vice president Dr. Francine Kaufman noted ASPIRE In-Home met both its safety and efficacy endpoints and it 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.
Hypoglycemia can prove to be fatal, especially at night when patients with diabetes are not likely to be aware of symptoms because they are asleep.
