Table 1.
Glycemic Outcomes in CGM-CGM Cohort
| Baseline | 26 Weeks | 52 Weeks | P-value baseline versus 52 Weeksa | |
|---|---|---|---|---|
| CGM-measured outcomes | ||||
| N | 100 | 96 | 94 | |
| Hours of data | ||||
| Mean ± SD | 353 ± 74 | 604 ± 97 | 592 ± 111 | |
| Median (IQR) | 324 (309, 388) | 640 (608, 652) | 638 (597, 653) | |
| Hypoglycemiab | ||||
| % Time <70 mg/dL | <0.001 | |||
| Mean ± SD | 6.6 ± 4.9 | 2.8 ± 1.9 | 3.2 ± 2.4 | |
| Median (IQR) | 5.0 (3.0, 9.6) | 2.6 (1.5, 3.9) | 2.8 (1.6, 4.3) | |
| % Time <54 mg/dL | <0.001 | |||
| Mean ± SD | 2.5 ± 2.4 | 0.6 ± 0.7 | 0.7 ± 1.1 | |
| Median (IQR) | 1.9 (0.9, 3.5) | 0.4 (0.2, 0.8) | 0.4 (0.1, 0.9) | |
| Rate of hypoglycemic episodes per weekc | <0.001 | |||
| Mean ± SD | 3.0 ± 2.4 | 1.3 ± 1.4 | 1.3 ± 1.3 | |
| Median (IQR) | 2.6 (1.5, 3.8) | 0.9 (0.3, 1.7) | 0.9 (0.3, 2.0) | |
| Glucose control | ||||
| % Time in range 70–180 mg/dL | <0.001 | |||
| Mean ± SD | 56 ± 14 | 64 ± 14 | 64 ± 15 | |
| Median (IQR) | 59 (46, 66) | 63 (55, 74) | 65 (56, 76) | |
| Mean glucose (mg/dL) | 0.05 | |||
| Mean ± SD | 167 ± 29 | 163 ± 22 | 161 ± 26 | |
| Median (IQR) | 162 (149, 183) | 162 (145, 176) | 160 (145, 174) | |
| Coefficient of variation (%) | <0.001 | |||
| Mean ± SD | 41 ± 6 | 36 ± 5 | 36 ± 5 | |
| Median (IQR) | 41 (37, 46) | 36 (33, 39) | 36 (33, 39) | |
| Hyperglycemia | ||||
| % Time >180 mg/dL | 0.002 | |||
| Mean ± SD | 37 ± 16 | 34 ± 14 | 33 ± 16 | |
| Median (IQR) | 34 (27, 49) | 35 (23, 42) | 32 (21, 41) | |
| % Time >250 mg/dL | <0.001 | |||
| Mean ± SD | 14 ± 11 | 10 ± 8 | 10 ± 9 | |
| Median (IQR) | 10 (6, 20) | 8 (3, 14) | 7 (3, 12) | |
| % Time >300 mg/dL | <0.001 | |||
| Mean ± SD | 6.0 ± 6.5 | 3.6 ± 4.2 | 3.7 ± 5.2 | |
| Median (IQR) | 3.7 (1.5, 8.3) | 2.2 (0.6, 5.2) | 2.1 (0.5, 4.1) | |
| Meeting targets, n (%) | ||||
| % Time <70 mg/dL <4% | 34 (34) | 72 (75) | 67 (71) | <0.001 |
| % Time <70 mg/dL <1% | 8 (8) | 16 (17) | 16 (17) | 0.009 |
| % Time <54 mg/dL <1% | 30 (30) | 78 (81) | 72 (77) | <0.001 |
| % Time in range 70–180 mg/dL >70% | 13 (13) | 34 (35) | 34 (36) | <0.001 |
| % Time in range 70–180 mg/dL >50% | 70 (70) | 79 (82) | 80 (85) | <0.001 |
| HbA1c | ||||
| N | 100 | 99 | 99 | |
| HbA1c % [mmol/mol] | 0.010 | |||
| Mean ± SD | 7.6 ± 0.9 [59 ± 10] | 7.2 ± 0.9 [56 ± 10] | 7.4 ± 1.0 [57 ± 10] | |
| Median (IQR) | 7.4 (6.9, 8.1) [57 (52, 65)] | 7.2 (6.6, 7.7) [55 (49, 61)] | 7.2 (6.7, 7.9) [55 (50, 63)] | |
| HbA1c <7.0%, n (%) | 28 (28) | 40 (40) | 35 (35) | 0.16 |
| HbA1c <7.5%, n (%) | 51 (51) | 64 (65) | 55 (56) | 0.37 |
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.
The P-values for 26 weeks versus 52 weeks for the hypoglycemia metrics were P = 0.45 for % time <70 mg/dL, P = 0.77 for % time <54 mg/dL, and P = 0.79 for rate of hypoglycemic episodes per week.
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.6
CGM, continuous glucose monitoring; HbA1c, hemoglobin A1c; IQR, interquartile range; SD, standard deviation.