Real-time Continuous Glucose Monitoring for Type 1 and Type 2 Diabetes

This report examines the use of the commercially available real-time continuous glucose monitoring (RT-CGM) systems that are designed to continuously measure glucose levels in the interstitial fluid surrounding skin cells—rather than in the blood—and provide real-time results for individuals with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). Assessment of RT-CGM in patients with other types of diabetes is outside the scope of this report.

Continuous glucose monitoring is intended to continuously measure glucose levels in the interstitial fluid of the subcutaneous layer of the skin and to provide real-time results for patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). The systems consist of three parts: a disposable, short-term sensor to measure glucose in interstitial fluid; a transmitter attached to the sensor; and a receiver that displays and stores glucose-value information. Using an applicator, the patient inserts a wire-like sensor just under the skin (subcutaneous tissue) of the abdomen or upper arm and wears it for three to seven days, depending on the product. Attaching the transmitter to the sensor allows wireless receipt of information. The pager-size receiver can be worn on a belt, carried in a pocket, or placed in a purse, where it receives information from the sensor/transmitter every one to five minutes. The receiver displays and stores real-time glucose values, glucose trends, and rate of change. It can alarm or vibrate for potentially dangerous, high- and low-blood glucose values. Long-term data can be downloaded to a computer for analysis. Trend reports and charts assess the effect of meals, exercise, insulin, and medication on glucose levels.

All real-time continuous glucose monitoring systems used in conjunction with self-monitoring of blood glucose (RT-CGM + SMBG) by fingerstick testing are indicated for continuous or periodic monitoring of interstitial-fluid glucose levels in adults (ages 18 or older) with T1DM and T2DM to improve diabetes management. Contraindications in...