Insulet has announced FDA approval of its new diabetes treatment.
The Insulet Corporation has announced the launch of its first commercial product, the OmniPod Insulin Management System (IMS), which has received clearance from the US Food and Drug Administration. The two-part system will combine the healthcare benefits of continuous subcutaneous insulin infusion (CSII) and blood glucose monitoring technology. CSII, utilizing an insulin pump, eliminates the need for daily insulin injections making intensive insulin therapy significantly easier.
The OmniPod IMS features fully programmable continuous subcutaneous insulin delivery with multiple basal rates and bolus options, suggested bolus calculations, safety checks, and alarm features.
The OmniPod IMS represents a promising and welcome step in the evolution of CSII towards smaller and more user-friendly devices. The proposed advantage of the OmniPod IMS compared to current insulin pumps is its fully-integrated design with only two components – the OmniPod and the Personal Diabetes Manager (PDM). The OmniPod combines an integrated infusion set, automatic inserter, and insulin reservoir. It delivers insulin according to pre-programmed instructions from the wireless, handheld PDM. Once the OmniPod is programmed, the PDM is used to check blood glucose levels, give bolus dosages, and adjust basal rates.
However, one must be aware that CSII is mainly targeted to type 1 diabetics, a group representing only about 5% of the total diabetic population. Therefore the search for a usable, convenient and practical method of insulin delivery for the full spectrum of diabetics goes on. One other option is the ‘closed-loop system’, still in the developmental stage. This system incorporates an insulin pump and a glucose sensor that will regulate the insulin without the need for the patient’s intervention. However, a relatively high rate of false alarms, creating the potential for the miscalculation of the required insulin, has so far tempered experts’ interest in these systems.
