Health Problem: Diabetes mellitus (DM) is a chronic, progressive disease characterized by impaired metabolism of carbohydrates. DM affects approximately 30 million Americans (9.4% of the population) and costs $327 billion annually in the United States.

Technology Description: The OmniPod Insulin Management System (OmniPod system) is a tubeless, single-use, disposable continuous subcutaneous insulin infusion (CSII) device that adheres to the skin. The OmniPod system includes the Pod and the Personal Diabetes Manager (PDM), which remotely controls and monitors the Pod. The PDM also has a built-in blood glucose meter and an insulin bolus calculator. Pods are supplied empty and are filled with 200 units of insulin prior to insertion. A fresh Pod is inserted every 72 hours or sooner if the insulin supply has been exhausted.

Controversy: When insulin is required to control blood glucose levels in patients with DM, the options are either daily injections or use of an electronic pump and infusion set system. Injections administer insulin in intermittent boluses, are indiscreet and inconvenient, and may cause pain. Electronic pumps provide continuous infusion of insulin, which is a more natural state; however, the devices are cumbersome due to multiple components, including the pump and insulin reservoir, which must be affixed to clothing in some manner..

Key Questions:

  • Is the OmniPod System effective in the management of DM?

  • How does the OmniPod system compare with multiple daily injections of insulin or other insulin infusion devices?

  • Is the OmniPod system safe?

  • Have definitive patient selection criteria been identified for use of the OmniPod system?

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