Managed Care - August 2008 - (Page 42) TABLE 2 Results of paired CGM/blood glucose value paired assessment Group category Type 1 Glucose range (mg/dL) <55 180 180 180 <55 180 180 180 Masked mean (SD) 0.55 (0.8) 1.42 (1.4) 13.11 (3.6) 9.47 (4.2) 1.1 (0.8) 2.5 (0.9) 1.0 (0.6) 3.9 (1.5) 0.15 (0.3) 0.62 (0.8) 13.75 (5.5) 9.62 (5.8) 0.5 (0.5) 2.3 (0.6) 0.9 (0.7) 4.3 (3.2) Unmasked mean (SD) 0.25 (0.4) 0.83 (0.8) 13.79 (3.8) 9.38 (4.1) 0.8 (0.6) 2.7 (0.7) 0.7 (0.4) 3.5 (1.3) 0.20 (1.0) 0.69 (1.0) 15.38 (4.1) 7.93 (4.4) 0.6 (0.6) 2.4 (0.7) 0.6 (0.5) 3.3 (2.0) Difference P-value <.001 <.001 .0038 .7079 <.0001 .020 <.0001 .0025 .3676 .6520 .0027 .0057 .3861 .1512 .1260 .0024 Analysis Hours per day spent Hours per day spent Hours per day spent Hours per day spent Number of episodes per day Number of episodes per day Average duration of episode (hrs) Average duration of episode (hrs) Hours per day spent Hours per day spent Hours per day spent Hours per day spent Number of episodes per day Number of episodes per day Average duration of episode Average duration of episode Type 2 cent). Analysis of the hyperglycemic threshold alarm (300 mg/dL) demonstrated that 0.5 percent were false alerts, while the remaining alarms were either true (89.9 percent) or within 20 percent of the blood glucose test result (9.6 percent). The glycemic events and time spent in hypoglycemic ( 180 mg/dL) are listed in Table 2. Comparing the masked and unmasked periods, all subjects combined demonstrated a significant (P<.001) decrease in the time spent in hypoglycemia (<70 mg/dL) with the average amount of time per 24 hours decreasing from 1.23 hours to 0.80 hours. Subjects with type 1 diabetes mellitus demonstrated a significant (P<.001) reduction in the time spent below the two predefined hypoglycemia (55 and 70 mg/dL) thresholds (−55 percent and −42 percent, respectively). The average number of hypoglycemic episodes per day decreased significantly (1.1 to 0.8; P<.001) as did the average duration of the episodes (1.0 hour to 0.7 hour; P<.001) and the average magnitude of the excursions (54.7 mg/dL to 58.4 mg/dL; P 180 mg/dL) (3.9 hours to 3.5 hours; P=.0025) and the mean number of hours per day spent in the target glycemic range of 70 to 180 mg/dL (13.75 to 15.38; P=.0027). Among subjects with type 2 diabetes mellitus, the duration of time spent in hyperglycemia improved in the unmasked phase. The time spent in the euglycemic range increased by 12 percent (P=.0027) and the time spent in hyperglycemia (>180 mg/dL) decreased by 18 percent (P=.0057). The measures of hypoglycemia were largely unchanged in the unmasked phase. Safety and insertion site findings There were no unanticipated adverse device effects reported for the study. However, two adverse events related to the device were reported: two occurrences of itching lasting more than seven days reported by the same subject, each of which resolved and did not require medical treatment. All the other adverse events (n=15) were transient and unrelated to the device or study. The one serious adverse event reported occurred in a subject who experienced an episode of severe hypoglycemia and lost consciousness. The subject was administered glucagon and recovered completely. The subject had a history of regular severe hypoglycemia and the episode was deemed unrelated to either the study device or study procedure. Examination of the sensor insertion sites indicated that 17.4 percent of subjects experienced some arm bruising. Other possible insertion effects assessed (erythema, edema, rash, bleeding, pain or itching) were reported by <5 percent of subjects. Study questionnaire Questionnaire results were available from 131 subjects. The results of the study questionnaire (Table 3) demonstrated high levels of subject satisfaction and the ability to use and understand the system. Subjects in- 42 MANAGED CARE / AUGUST 2008
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