Health Problem: Diabetes mellitus (DM or diabetes) is a chronic, progressive disease characterized by impaired metabolism of carbohydrates. This disorder manifests in 2 main forms: type 1 DM and type 2 DM. Diabetes is associated with a high incidence of vascular disease involving the large and small blood vessels, which contribute to late secondary complications of diabetes, including atherosclerotic heart disease, peripheral atherosclerotic disease, nephropathy, neuropathy, and retinopathy. Diabetes affects approximately 30 million Americans (9.4% of the population) and costs $327 billion annually in the United States. Management of DM involves monitoring blood glucose levels and treatment may include diet, exercise, weight loss, antihyperglycemic medications, and insulin.
Technology Description: Continuous glucose monitors (CGMs) 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 diabetic patient. The Eversense system represents a divergence from traditional CGMs in that it is uses a fully implanted sensor with a removable transmitter that sends data to a smart device. In addition, the Eversense CGM sensor is replaced every 90 days via a 5-minute in-office minimally invasive procedure.
Controversy: People with DM need to measure blood glucose levels several times a day for optimal management of disease and prevention of future complications. This process requires finger sticks to draw blood and subsequent testing with a glucose meter. The process causes pain and is inconvenient, thus patient compliance is an issue. Also, self-monitored blood glucose only provides the blood glucose level at the moment of the test, which can result in some degree of undetected hypoglycemia or hyperglycemia. Traditional transcutaneous CGM systems have a short duration of use, requiring replacement every 5 to 7 days. Some suggest that sensor life may be inhibited due to stability of the enzymes used for monitoring glucose, by bio-fouling of the sensor electrodes, or by resulting inflammatory responses due to the partial implantation. The Eversense CGM was developed as a fully implantable subcutaneous sensor to overcome these potential limitations.
Key Questions:
- Does the Eversense CGM system accurately measure glucose levels in interstitial fluid in adults with DM?
- Does the information obtained from the Eversense CGM improve short-term glycemic outcomes and long-term health outcomes in adults with DM?
- How does Eversense CGM compare with alternative methods of glucose monitoring (e.g., capillary blood glucose measurements, other CGM systems)?
- Is Eversense CGM safe?
- Have definitive patient selection criteria been identified for Eversense CGM?
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