Table 2.
Performance Characteristics of the FreeStyle Navigator CGM with the TRUstart Algorithma
Point EGA | ||||
Zone A | 80.3 (6306) | |||
Zone B | 18.0 (1410) | |||
Zone C | 0.2 (16) | |||
Zone D | 1.5 (120) | |||
Zone E | 0 (0) | |||
Rate EGA | ||||
Zone A | 79.1 (6212) | |||
Zone B | 16.1 (1266) | |||
Zone C | 2.1 (162) | |||
Zone D | 2.0 (158) | |||
Zone E | 0.7 (54) | |||
G-EGA (combined grids to give overall CGM clinical accuracy) | ||||
Hypoglycemia (≤70 mg/dl) | Euglycemia (71–180 mg/dl) | Hyperglycemia (>180 mg/dl) | All data | |
Clinically accurate | 53.6 (162) | 95.6 (4393) | 94.7 (2800) | 93.7 (7355) |
Benign errors | 7.0 (21) | 3.7 (168) | 3.1 (91) | 3.6 (280) |
Clinical errors | 39.4 (119) | 0.7 (32) | 2.2 (66) | 2.8 (217) |
Statistical measures of concordance of CGM glucose with reference glucose values | ||||
Mean ARD | 21.6 (302) | 15.5 (4593) | 10.5 (2957) | 14.5 (7852) |
Median ARD | 17.5 (302) | 11.8 (4593) | 8.3 (2957) | 10.7 (7852) |
ISO accuracy | 44.0 (133) | 72.3 (3319) | 87.4 (2584) | 76.9 (6036) |
Table entries are % (n). Zone A represents clinically accurate; zone B represents benign or no treatment errors; zone C represents overcorrection errors; zone D represents a potentially dangerous failure to treat; and zone E represents erroneous treatment.