Table 3.
Glycemic Outcomes in the BGM-Crossover Group.
| Baseline | 26 weeks | 52 weeks |
P-value 26 vs 52 weeks a |
|
|---|---|---|---|---|
| CGM-measured outcomes | ||||
| N | 44 | 43 | 39 | |
| Hours of data | 315 (263, 362) |
150 (131, 159) |
612 (517, 636) |
|
| Glucose control | ||||
| % Time in range 70-180 mg/dL | 41 ± 10 | 38 ± 13 | 40 ± 12 | .31 |
| % Time in range 70-180 mg/dL >60% | 1 (2%) | 1 (2%) | 3 (8%) | .16 |
| Mean glucose (mg/dL) | 199 ± 25 | 203 ± 35 | 205 ± 26 | .84 |
| Coefficient of variation (%) | 44 ± 7 | 44 ± 8 | 39 ± 6 | <.001 |
| Hyperglycemia | ||||
| % Time > 180 mg/dL | 54 ± 12 | 55 ± 16 | 57 ± 13 | .45 |
| % Time > 250 mg/dL | 27 (22, 34) | 30 (19, 40) | 26 (20, 37) | .18 |
| % Time > 300 mg/dL | 14 (9, 19) | 15 (9, 26) | 14 (8, 19) | .040 |
| Hypoglycemia | ||||
| % Time < 70 mg/dL | 3.7 (2.2, 6.7) | 4.5 (2.0, 8.3) | 1.7 (0.7, 3.6) | <.001 |
| Meeting target of <4% time <70 mg/dL | 23 (52%) | 21 (49%) | 32 (82%) | .003 |
| % Time < 54 mg/dL | 1.0 (0.4, 3.6) | 1.3 (0.4, 4.3) | 0.3 (0.1, 1.0) | .007 |
| Meeting target of <1% time <54 mg/dL | 22 (50%) | 17 (40%) | 30 (77%) | .002 |
| Hypoglycemic events per week b | 1.5 (0.8, 4.1) | 1.7 (1.0, 4.6) | 0.7 (0.0, 1.6) | .002 |
| HbA1c | ||||
| N | 44 | 44 | 44 | |
| HbA1c, mean ± SD | 8.2 ± 0.7 | 8.1 ± 0.8 | 8.3 ± 0.9 | 0.014 |
Data are mean ± SD, median (IQR), or N (%).
Abbreviations: BGM, blood glucose monitoring; CGM, continuous glucose monitoring; IQR, interquartile range.
a
P-value from a paired t-test, signed rank test, or McNemar’s test, as appropriate. Only includes participants who had values at both time points. P-values are adjusted for multiple comparisons to control the false discovery rate (FDR).
b
A CGM-measured hypoglycemic event was defined as 15 consecutive minutes with a sensor glucose value <54 mg/dL. The end of the hypoglycemic event was defined as a minimum of 15 consecutive minutes with a sensor glucose concentration >70 mg/dL. 16