borderline significanceP = .026
Scores decreased in 15/18 measures, with 6 reaching statistical significance and 2 reaching borderline significance, and composite score decreasing from 52.3 to 43.8 ( P = .026).
Scores decreased in 15/18 measures, with 6 reaching statistical significance and 2 reaching borderline significance, and composite score decreasing from 52.3 to 43.8 ( P = .026).
Although not statistically significant, total minutes spent low on CGM during daytime hours, when patients are eating and therefore experience the highest frequency of postprandial hypoglycemic episodes, showed a trend toward less time spent below all 3 glycemic thresholds (<70, <54, and <40 mg/dL) during the unblinded vs blinded CGM use.
Level 3 events (need for third-party assistance) are also important to quantify: in the current study, we did not evaluate this endpoint, but CGM-detected events <40 mg/dL, which would normally be associated with a level 3 presentation, were 5-fold reduced and reduction in time (minutes on CGM) spent <40 mg/dL showed a nonsignificant trend during the diurnal monitoring.
Time in minutes spent below each hypoglycemic threshold (<70, 54, and 40 mg/dL) as calculated from CGM tracings did not differ significantly between the blinded and unblinded periods ( Table 3 ), but when separated into diurnal and nocturnal time frames, a consistent trend was seen in the diurnal (but not the nocturnal) time frame toward less time spent in hypoglycemia in the unblinded vs the blinded treatment period, although the difference did not reach statistical significance ( Table 4 ).