Table 2

CGM outcome metrics (N = 102)*

BaselinePLGSSAPPLGS – SAP treatment difference (95% CI)P value
Hours of data312 (297, 560)473 (447, 485)467 (447, 482)N/AN/A
Percent of glucose <70 mg/dL 3.6 (1.9, 5.6)2.6 (1.4, 4.0)3.2 (1.9, 6.1)−0.8 (−1.1, −0.5)<0.001
Overall glucose control
 Mean glucose (mg/dL)158 ± 27159 ± 25159 ± 27−1 (−3, +1)0.40
 %Glucose 70–180 mg/dL 64 ± 1565 ± 1563 ± 15+2 (+1, +4)<0.001
 Coefficient of variation, %§37 ± 536 ± 537 ± 5−1% (−2, 0)0.007
Hypoglycemia
 %Glucose <60 mg/dL1.2 (0.6, 2.1)0.9 (0.4, 1.6)1.2 (0.6, 2.7)−0.3 (−0.5, −0.2)<0.001
 %Glucose <54 mg/dL§0.6 (0.2, 1.0)0.4 (0.1, 0.8)0.5 (0.2, 1.4)−0.1 (−0.2, −0.1)<0.001
 %Glucose <50 mg/dL0.3 (0.1, 0.6)0.2 (0.1, 0.5)0.3 (0.1, 0.7)0.0 (−0.1, 0.0)0.002
 Area over curve <70 mg/dL0.31 (0.19, 0.55)0.25 (0.11, 0.40)0.30 (0.17, 0.65)−0.07 (−0.11, −0.05)<0.001
 Low blood glucose index0.9 (0.6, 1.3)0.8 (0.5, 1.1)0.9 (0.6, 1.5)−0.1 (−0.2, −0.1)<0.001
 Hypoglycemic events per week1.1 (0.5, 2.4)0.8 (0.3, 1.9)1.1 (0.4, 3.0)−0.3 (−0.4, 0.0)<0.001
Hyperglycemia
 %Glucose >250 mg/dL7 (3, 15)8 (3, 13)8 (3, 16)−1 (−1, 0)0.008
 %Glucose >180 mg/dL32 ± 1732 ± 1533 ± 16−1 (−3, 0)0.12
 Area under curve >180 mg/dL14.7 (7.5, 24.7)15.8 (8.3, 24.1)16.9 (7.4, 25.8)−0.87 (−1.76, −0.03)0.04
 High blood glucose index6.7 (3.9, 9.9)6.9 (4.4, 9.6)7.4 (4.2, 10.1)−0.3 (−0.6, 0.0)0.05
  • Baseline, PLGS, and SAP data are presented as median (quartiles) or as mean ± SD.

  • *Includes all participants with at least one CGM glucose sensor reading in each treatment period. One participant did not have useable baseline data.

  • †Based on a repeated-measures regression model adjusting for period. Nonparametric analysis was conducted for variables with a skewed distribution (exceptions are mean glucose, glucose coefficient of variation, percentage 70–180 mg/dL, and percentage >180 mg/dL). P values were adjusted for multiple comparisons using the Benjamini-Hochberg adaptive false discovery rate procedure with the exception of the primary outcome, percentage <70 mg/dL.

  • ‡From Table 1.

  • §Post hoc analysis.

  • ‖CI may include 0 even though P value <0.05 due to rounding.

  • ¶A hypoglycemia event was defined as at least two sensor values <54 mg/dL that were ≥15 min apart with no intervening values >54 mg/dL. At least two sensor values >70 mg/dL that are ≥30 min apart with no intervening values <70 mg/dL are required to end a hypoglycemic event.