US-based Medtronic's sensor-augmented insulin pump with Threshold Suspend feature helps in reducing nocturnal hypoglycemia without affecting glycated hemoglobin level (HbA1C), a study results show.
Threshold Suspend, an automated insulin pump feature in an investigational MiniMed integrated system, automatically suspends delivery of insulin temporarily when sensor glucose values reach a pre-set low level.
Only when the threshold is met, that the insulin pump raises alarm. The insulin delivery is then stopped for two hours.
The ASPIRE In-Home study compared two MiniMed sensor-augmented insulin pumps with continuous glucose monitoring – one with the Threshold feature and one without it.
This study received investigational device exemption (IDE) from the US Food and Drug Administration.
In this study, about 247 patients suffering with type 1 diabetes and documented nocturnal hypoglycemia were randomly chosen for a sensor-augmented insulin-pump therapy.
Out of this, about 121 patients were given with Threshold Suspend feature while the remaining number of patients were given without it for three months.
The study found that the MiniMed sensor-augmented insulin pump with the Threshold feature had shown encouraging 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 be dangerous, especially at night when diabetics are not likely to be aware of symptoms because they are asleep.
Image: MiniMed Paradigm REAL-Time Revel System. Photo: Courtesy of Medtronic.