The SCGM1 System: subcutaneous continuous glucose monitoring based on microdialysis technique.

Abstract

The SCGM1 System is designed to allow continuous glucose monitoring in the subcutaneous interstitial fluid for up to 120 h. The system is based on the microdialysis technique and is composed of three components: (1) a disposable Cassette, which contains the microdialysis catheter (with the necessary tubes), an electrochemical flow-through sensor for glucose measurement, and the fluid reservoirs for both the microdialysis perfusate and a reagent solution containing glucose oxidase; (2) the Sensor Unit, which houses the Cassette and is worn by the patient using a belt pack; and (3) the Data Manager, with an integrated blood glucose meter for the calibration of the glucose signal. The Data Manager also has the option of displaying the continuous glucose signal. The Sensor Unit and Data Manager exchange glucose data and calibration data by radio transmission. In vitro precision was assessed by measurements of two standard glucose solutions (90 mg/dL, 3.4%; 360 mg/dL, 2.4%) over a time course of 4 days. The mean difference (+/- SD) between SCGM1 System devices (n = 11) and 15 glucose standard solutions with different concentrations was 1.4 +/- 3.5 mg/dL. The mean relative difference and the mean absolute relative difference ranged from - 0.6% to 3.7% and from 0.2% to 3.8%, respectively. The inherent physical lag time was 31 +/- 2 min (n = 10). The interference on the glucose signal of ascorbic acid, acetaminophen, and uric acid at the highest physiological concentrations was below 4%. The SCGM1 System showed a reliable and precise performance under in vitro conditions.