Subcutaneous open-loop insulin delivery for type 1 diabetes: Paradigm Real-Time System.

(1) An open-loop insulin delivery system combines an external insulin pump with continuous monitoring of glucose levels via a subcutaneous sensor. The sensor communicates glucose readings to the pump using a radio transmitter. (2) In four small, comparative studies, adults and children with poorly controlled type 1 diabetes who were randomized to use the Paradigm Real-Time System had clinically important improvements in A1c (a measure of average glycemic control over the previous three months) compared to baseline. (3) Some studies found greater improvements in A1c and less hypoglycemia with the Paradigm Real-Time System compared to multiple daily insulin injections or pump therapy combined with conventional glucometer readings. (4) Adverse events with the Paradigm Real- Time System include infection, itching, irritation, and redness at the site of the glucose sensor, and rare instances of insulin pump malfunction. (5) Based on the limited amount of research published to date, the impact of the Paradigm Real-Time System on long-term glycemic control, prevention of diabetic complications, or quality of life is unclear.