Table 2.
Glycemic Outcomes in BGM-CGM Cohort
| Baseline | 26 Weeks | 52 Weeks | P-value 26 weeks versus 52 weeksa | |
|---|---|---|---|---|
| CGM-measured outcomes | ||||
| N | 94 | 90 | 88 | |
| Hours of data | ||||
| Mean ± SD | 351 ± 69 | 150 ± 38 | 592 ± 109 | |
| Median (IQR) | 327 (310, 400) | 152 (138, 156) | 633 (593, 652) | |
| Hypoglycemia | ||||
| % Time <70 mg/dL | <0.001 | |||
| Mean ± SD | 6.6 ± 5.2 | 6.0 ± 5.8 | 2.9 ± 3.2 | |
| Median (IQR) | 4.7 (2.4, 9.7) | 3.9 (1.3, 9.5) | 1.9 (0.6, 3.5) | |
| % Time <54 mg/dL | <0.001 | |||
| Mean ± SD | 2.5 ± 2.5 | 2.3 ± 2.9 | 0.7 ± 1.2 | |
| Median (IQR) | 1.5 (0.5, 4.1) | 1.1 (0.2, 3.4) | 0.2 (0.0, 0.8) | |
| Rate of hypoglycemic episodes per weekb | <0.001 | |||
| Mean ± SD | 3.0 ± 2.7 | 2.7 ± 2.8 | 1.2 ± 1.7 | |
| Median (IQR) | 2.1 (0.9, 4.1) | 1.8 (0.0, 4.3) | 0.5 (0.0, 1.7) | |
| Glucose control | ||||
| % Time in range 70–180 mg/dL | 0.006 | |||
| Mean ± SD | 56 ± 15 | 56 ± 15 | 60 ± 16 | |
| Median (IQR) | 57 (48, 67) | 55 (45, 67) | 62 (51, 72) | |
| Mean glucose (mg/dL) | 0.69 | |||
| Mean ± SD | 168 ± 31 | 169 ± 30 | 168 ± 29 | |
| Median (IQR) | 164 (143, 183) | 164 (146, 185) | 165 (149, 182) | |
| Coefficient of variation (%) | <0.001 | |||
| Mean ± SD | 42 ± 7 | 40 ± 8 | 36 ± 5 | |
| Median (IQR) | 41 (38, 46) | 40 (34, 45) | 36 (32, 39) | |
| Hyperglycemia | ||||
| % Time >180 mg/dL | 0.32 | |||
| Mean ± SD | 37 ± 17 | 38 ± 17 | 37 ± 17 | |
| Median (IQR) | 35 (23, 49) | 37 (26, 47) | 35 (25, 48) | |
| % Time >250 mg/dL | 0.022 | |||
| Mean ± SD | 15 ± 12 | 14 ± 12 | 12 ± 11 | |
| Median (IQR) | 13 (6, 21) | 12 (5, 21) | 8 (4, 15) | |
| % Time >300 mg/dL | 0.016 | |||
| Mean ± SD | 6.7 ± 7.0 | 6.0 ± 7.1 | 4.3 ± 6.5 | |
| Median (IQR) | 4.2 (1.3, 9.7) | 3.8 (1.1, 8.0) | 2.1 (0.9, 5.2) | |
| Meeting targets, n (%) | ||||
| % Time <70 mg/dL <4% | 39 (41) | 46 (51) | 70 (80) | <0.001 |
| % Time <70 mg/dL <1% | 8 (9) | 17 (19) | 29 (33) | <0.001 |
| % Time <54 mg/dL <1% | 39 (41) | 42 (47) | 72 (82) | <0.001 |
| % Time in range 70–180 mg/dL >70% | 15 (16) | 16 (18) | 25 (28) | 0.004 |
| % Time in range 70–180 mg/dL >50% | 63 (67) | 62 (69) | 68 (77) | 0.007 |
| HbA1c | ||||
| N | 94 | 94 | 93 | |
| HbA1c % [mmol/mol] | 0.025 | |||
| Mean ± SD | 7.5 ± 0.8 [58 ± 9] | 7.5 ± 0.8 [58 ± 9] | 7.3 ± 0.8 [57 ± 9] | |
| Median (IQR) | 7.4 (6.8, 8.0) [57 (51, 64)] | 7.3 (6.8, 8.1) [56 (51, 65)] | 7.3 (6.8, 7.8) [56 (51, 62)] | |
| HbA1c <7.0%, n (%) | 30 (32) | 29 (31) | 29 (31) | 0.81 |
| HbA1c <7.5%, n (%) | 48 (51) | 53 (56) | 55 (59) | 0.51 |
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.
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.6