Clinical performance of CGMS in type 1 @entity6 XXXX treated by continuous subcutaneous insulin infusion using insulin analogs.

@entity1 @entity6 @entity72644 @entity4053 @entity413
OBJECTIVE: Performance criteria have been established for in vitro blood @entity413 monitoring, particularly for the self-monitoring of blood @entity413 using @entity413 meters. Devices intended for use in the future, such as the continuous @entity413 monitoring system (CGMS), should satisfy similar criteria, particularly in @entity6 @entity1 under intensive therapy. RESEARCH DESIGN AND METHODS: The analysis was conducted on 18 type 1 @entity6 @entity1 (not controlled, HbA(1c) >7.5%) treated by external pump using insulin analogs. Each @entity1 received a @entity413 sensor for 3 days during his/her hospitalization and was instructed in its operation. Medtronic criteria were used to determine the accuracy of the CGMS. In addition, the data were analyzed according to American @entity6 Association (ADA) criteria, Clarke Error Grid analysis, and method of residuals, with the @entity413 oxidase method using a Beckman analyzer used as the reference method. Specificity and sensitivity were evaluated from the viewpoint of accuracy in the detection of @entity4053 . For nine @entity1 , two @entity413 sensors were simultaneously inserted into an abdominal site to determine the reproducibility of the system. RESULTS-Among the 33 @entity413 sensors inserted, 6 (18%) were nonfunctional. The mean duration of CGMS recording was 63 +/- 12 h. From all of the 692 sets of data that paired @entity413 readings and CGMS, the coefficients of correlation ranged from 0.87 to 0.92 and the mean absolute error ranged from 12.8 to 15.7%. The time experienced in @entity4053 (<55 mg/dl) was reported at 86 +/- 62 min/day. Only 39% of the CGMS values satisfied the ADA precision criteria to within +/-10%, and 19% of these values satisfied the future ADA precision criteria of accuracy to within +/-5%. The means of difference method showed that the CGMS slightly underestimated the plasma @entity413 values (mean = -12 mg/dl). Error grid analysis showed only 77% of the @entity413 sensor values were in zone A, and 98.9% were in zones A and B. Two values fell in zone C and a single value fell in zone D. The sensitivity and specificity of the CGMS to detect @entity4053 were 33 and 96%, respectively. A total of 6666 paired sensor values were recorded with a coefficient of correlation of 0.84 with a @entity72644 .25%. CONCLUSIONS: CGMS could be useful in routine clinical practice to provide much more information on the @entity413 profile than intermittent self-monitoring of blood @entity413 (SMBG). However, CGMS cannot be used as a replacement for @entity413 meters because it does not satisfy the conventional performance goals set down for in vitro @entity413 measurements and could therefore lead to clinically incorrect treatment decisions.
