Focus of the Report: The use of the MiniMed 670G Insulin Pump System for the management of diabetes mellitus (DM).

Technology Description: An artificial pancreas (AP) or closed-loop system includes a continuous subcutaneous insulin infusion (CSII) pump, a continuous glucose monitor (CGM), and a control algorithm to help reduce time spent at high and low glucose levels. The MiniMed 670G Insulin Pump System is a hybrid closed-loop (HCL) system that uses an external insulin pump and predictive SmartGuard technology. The pump can be used as a stand-alone pump or can be integrated with the Guardian Sensor 3 CGM system. If used with the CGM, the SmartGuard technology can be operated in 2 modes: Manual Mode and Auto Mode. In Manual Mode, or open-loop setting, the MiniMed 670G can be used as a traditional insulin pump with the option of using the “suspend-before-low” feature that automatically stops insulin delivery before glucose levels go below a set threshold. Auto Mode enables the HCL feature, which automatically adjusts insulin delivery every 5 minutes based on the CGM sensor glucose level to maintain a target glucose level of 120 milligrams per deciliter (mg/dL).

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. Achieving glycemic control may be challenging for patients with type 1 DM. An artificial pancreas may have advantages over other diabetes management options; however, the suitability and potential disadvantages of these systems may require individual consideration.

Key Questions:

  • Is the MiniMed 670G system effective in managing diabetes?

  • How does MiniMed 670G system compare with clinical alternatives for managing diabetes?

  • Is the MiniMed 670G system safe for managing diabetes?

  • Have definitive patient selection criteria been identified for the MiniMed 670G system?

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