Focus of the Report: This Health Technology Assessment focuses on the use of the Eversense Continuous Glucose Monitoring (CGM) System (Senseonics Inc.). This minimally invasive, implantable CGM device is used to continuously monitor interstitial glucose levels in patients with diabetes mellitus (DM), with the goal of improving glycemic control and long-term outcomes.

Technology Description: CGM systems are minimally invasive devices that measure glucose in interstitial fluid at predetermined intervals. These measurements assist in determining the appropriate insulin dosage required to achieve glycemic control in a patient with DM. The Eversense CGM System represents a divergence from traditional CGM systems in that it uses a fully implanted sensor with a removable transmitter that sends data to a smart device.

Controversy: People with DM need to measure their BG levels several times a day for optimal disease management and to prevent hypoglycemia or hyperglycemia as well as future complications. This process requires fingersticks to draw blood and subsequent testing with a glucometer. Traditional transcutaneous CGM systems have a short duration of use, requiring replacement every 5 to 7 days. The Eversense CGM System was developed as a fully implantable subcutaneous sensor to overcome these potential limitations since it monitors for 90 to 180 days.

Key Questions:

  • Does the Eversense Continuous Glucose Monitoring (CGM) System accurately measure glucose levels in interstitial fluid in adults with diabetes mellitus (DM)?

  • Does the information obtained from the Eversense CGM System improve short-term glycemic outcomes and long-term health outcomes in adults with DM?

  • How does the Eversense CGM System compare with alternative methods of glucose monitoring (e.g., capillary blood glucose [BG] measurements, other CGM systems)?

  • Is the Eversense CGM System safe?

  • Have definitive patient selection criteria been identified for use of the Eversense CGM System?

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