Table 2

Glycemic outcomes of trial participants

SAPClosed-loopAbsolute difference (95% CI)P value
Crossover phase time in T1D pregnancy target range (%)*60.162.32.1 (−4.1 to 8.3)0.47
Secondary glycemic outcome
 Mean CGM glucose (mg/dL)131.4131.40 (−0.3 to 0.4)0.85
 Time >140 mg/dL or 7.8 mmol/L (%)36.636.1−0.6 (−7.4 to 6.3)0.86
 Time >180 mg/dL or 10 mmol/L (%)14.814.6−0.1 (−4.2 to 4.0)0.94
 Time <63 mg/dL or 3.5 mmol/L (%)2.71.6−1.1 (−0.2 to −2.1)0.02
 Time 50 mg/dL or <2.8 mmol/L (%)0.50.2−0.2 (−0.0 to −0.5)0.03
 Hypoglycemic events >28 days12.5 (1–53)8 (1–17)0.04
 LBGI±1.41.0−0.4 (−0.7 to −0.1)0.01
 SD of sensor glucose (mg/dL)37.836.0−12.6 (−3.6 to 1.8)0.29
 TDD insulin (units/day)41.543.72.2 (−6.4 to 0.7)0.56
 Sensor wear (h/day)20.320.2
  • Data are derived from linear mixed-effects models except for number of hypoglycemic events, which are median (range) and defined as sensor glucose values <63 mg/dL for ≥20 min. Significantly different data appear in boldface type. TDD, total daily dose.

  • *The primary efficacy end point was the percentage of time that glucose was in the T1D pregnancy target range of 63–140 mg/dL (3.5–7.8 mmol/L) as recorded by CGM during each 4-week study phase.

  • ±The LBGI assessed the duration and extent of hypoglycemia.