. | Baseline . | PLGS . | SAP . | PLGS – SAP treatment difference (95% CI)† . | P value† . |
---|---|---|---|---|---|
Hours of data | 312 (297, 560) | 473 (447, 485) | 467 (447, 482) | N/A | N/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 ± 27 | 159 ± 25 | 159 ± 27 | −1 (−3, +1) | 0.40 |
%Glucose 70–180 mg/dL | 64 ± 15 | 65 ± 15 | 63 ± 15 | +2 (+1, +4) | <0.001 |
Coefficient of variation, %§ | 37 ± 5 | 36 ± 5 | 37 ± 5 | −1% (−2, 0)‖ | 0.007 |
Hypoglycemia | |||||
%Glucose <60 mg/dL | 1.2 (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/dL | 0.3 (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/dL | 0.31 (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 index | 0.9 (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 week¶ | 1.1 (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/dL | 7 (3, 15) | 8 (3, 13) | 8 (3, 16) | −1 (−1, 0)‖ | 0.008 |
%Glucose >180 mg/dL | 32 ± 17 | 32 ± 15 | 33 ± 16 | −1 (−3, 0) | 0.12 |
Area under curve >180 mg/dL | 14.7 (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 index | 6.7 (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 . | SAP . | PLGS – SAP treatment difference (95% CI)† . | P value† . |
---|---|---|---|---|---|
Hours of data | 312 (297, 560) | 473 (447, 485) | 467 (447, 482) | N/A | N/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 ± 27 | 159 ± 25 | 159 ± 27 | −1 (−3, +1) | 0.40 |
%Glucose 70–180 mg/dL | 64 ± 15 | 65 ± 15 | 63 ± 15 | +2 (+1, +4) | <0.001 |
Coefficient of variation, %§ | 37 ± 5 | 36 ± 5 | 37 ± 5 | −1% (−2, 0)‖ | 0.007 |
Hypoglycemia | |||||
%Glucose <60 mg/dL | 1.2 (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/dL | 0.3 (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/dL | 0.31 (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 index | 0.9 (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 week¶ | 1.1 (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/dL | 7 (3, 15) | 8 (3, 13) | 8 (3, 16) | −1 (−1, 0)‖ | 0.008 |
%Glucose >180 mg/dL | 32 ± 17 | 32 ± 15 | 33 ± 16 | −1 (−3, 0) | 0.12 |
Area under curve >180 mg/dL | 14.7 (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 index | 6.7 (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.