Insulet Corporation manufacturers the OmniPod Insulin Management System, which consists of an insulin delivery system and integrated blood glucose meter. It is a closed-loop system with automated cannula insertion for insulin delivery. In this closed-loop system, the input of glucose concentration transmits to the pump to coordinate the output, which is insulin delivery. The insulin-induced change in glucose concentration is then sensed and the data is fed back to the insulin pump. The OmniPod Insulin Management System includes a hand-held, wireless personal device manager, or PDM, and the pod, which is the insulin pump. A study published in the September 2006 issue of "Diabetes Care" reported 18 of 21 type 1 diabetics preferred the OmniPod system to their conventional insulin infusion system and glycemic control was significantly improved in these individuals.
Glycemic Control
A low blood glucose level, or hypoglycemia, causes acute symptoms of nervousness, sweating, tremors, confusion and possibly unconsciousness and death. On the other hand, hyperglycemia is a risk factor for cardiovascular disease, and kidney, eye and nerve dysfunction. The clinical goal of treatment for diabetics is to reduce blood glucose levels without causing an increase in the incidence of hypoglycemia. Type 1 diabetics, and to a lesser extent type 2 diabetics, on insulin treatment do not achieve good glycemic control with existing therapies. A study in "Diabetic Medicine" that reviewed multiple human trials reported that subcutaneous insulin infusion systems, in comparison to multiple daily insulin injections, reduced the frequency of severe hypoglycemia in type I diabetic patients.
Advantages
The goal of the closed-loop OmniPod insulin delivery system is to maintain glycemic control without manual insertion by the patient, thereby decreasing the burden of diabetes, especially in children. A review article published in the June 2010 issue of "Diabetes Technology and Therapeutics" reports that closed-loop insulin delivery systems are superior to other insulin delivery systems in maintaining glucose levels in the target range. The OmniPod system does not use tubing and because of subcutaneous glucose detection and insulin infusion, the OmniPod is relatively pain-free in comparison to multiple daily insulin injections.
Disadvantages
The OmniPod detects subcutaneous glucose concentration and delivers insulin subcutaneously, rather than directly into the bloodstream. Because there is a lag time between the increase in subcutaneous glucose concentration and elevation of blood glucose after eating a meal, there is potentially a problem of a longer-term elevation in blood glucose level after a meal. Thus, the closed-loop insulin delivery system may require manual insulin delivery after or just before a meal to prevent glycemic excursions. However, a recent study published in the May 2008 issue of "Diabetes Care" found that if pre-meal bolus doses of insulin were programmed into the insulin delivery system, high glucose levels after eating a meal were lowered in type 1 diabetic youth. The other reported disadvantage of insulin patch pumps was adhesive intolerance.
Cost
The OmniPod starter kit, containing a personal device manager and two OmniPods, is $800. Each OmniPod lasts approximately three days. A box of 10 OmniPods is $345 and would be required every month for the average diabetic person. Insulet Corporation has contracted with several private insurance companies to provide coverage for the OmniPod Insulin Management System.
Awards
The OmniPod Insulin Management System has received numerous awards, including the 2006 Medical Design Excellence Award presented by Canon Communications and the 2009 Edison Best New Product Award presented by the Marketing Executives Networking Group, a nonprofit professional association.
