We previously showed in a multicenter, outpatient, random-order crossover trial (n=39, 11 days each arm) that the bionic pancreas (BP) reduced group mean CGM glucose (141±10 vs. 162±29 mg/dl, p<0.0001) and percent of time spent <60 mg/dl (0.6±0.6% vs. 1.9±1.7%, p<0.0001) relative to usual care (UC) with pump ± CGM (El-Khatib FH, et al. Lancet. 2017; 389:369-80). We applied a new statistical approach to these data to determine how many individuals saw benefit for each outcome. We compared the average CGM glucose and average time <60 mg/dl between the BP and UC arms for each patient using autoregressive time series models to determine significance of differences. We found that 72% of subjects had a statistically significant reduction in mean CGM glucose, 51% had significant reduction in time <60 mg/dl, 44% had a significant reduction in both, and 97% had a significant reduction in at least one outcome. For every subject with mean CGM glucose that was nominally higher in the BP arm, the mean glucose in the BP arm was <154 mg/dl (predicted A1c <7%) and the average time <60 mg/dl was less than in the UC arm (significantly less in 2/6 cases). These analyses provide a new prospective on the efficacy of the BP emphasizing the benefit to individuals rather than the group as a whole. Subjects least likely to benefit were those who had extremely tight glycemic control and minimal hypoglycemia under UC.
Disclosure
J. Sloane: None.
