Table 2.
Glycemic Outcomes in the CGM Groups.
| CGM + FBI Group | Standard-CGM Group | P-value for treatment group difference at 52 weeksb,c | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 26 weeks | 52 weeks |
P-value Baseline vs 52 weeksa,b |
Baseline | 26 weeks | 52 weeks |
P-value Baseline vs 52 weeksa,b |
||
| CGM-measured outcomes | |||||||||
| N | 45 | 45 | 43 | 42 | 42 | 42 | |||
| Hours of data | 307 (282, 352) |
629 (579, 642) |
626 (535, 648) |
301 (282, 345) |
609 (545, 640) |
626 (571, 646) |
|||
| Glucose control | |||||||||
| % Time in range 70-180 mg/dL | 37 ± 12 | 42 ± 11 | 41 ± 12 | .09 | 41 ± 10 | 41 ± 10 | 44 ± 13 | .14 | .82 |
| % Time in range 70-180 mg/dL >60% | 1 (2%) | 2 (4%) | 3 (7%) | .32 | 1 (2%) | 0 (0%) | 5 (12%) | .10 | .98 |
| Mean glucose (mg/dL) | 213 ± 37 | 203 ± 26 | 204 ± 27 | .26 | 198 ± 28 | 203 ± 25 | 198 ± 30 | .97 | .82 |
| Coefficient of variation (%) | 43 ± 7 | 40 ± 4 | 40 ± 5 | .002 | 44 ± 7 | 39 ± 5 | 39 ± 6 | <.001 | .82 |
| Hyperglycemia | |||||||||
| % Time > 180 mg/dL | 58 ± 14 | 55 ± 12 | 56 ± 12 | .59 | 53 ± 13 | 57 ± 11 | 53 ± 14 | .89 | .82 |
| % Time > 250 mg/dL | 33 (26, 40) | 29 (17, 36) | 27 (21, 37) | .05 | 26 (22, 33) | 26 (19, 33) | 22 (14, 34) | .22 | .82 |
| % Time > 300 mg/dL | 18 (11, 24) | 14 (7, 21) | 13 (9, 18) | .004 | 13 (10, 18) | 12 (6, 17) | 10 (5, 16) | .14 | .82 |
| Hypoglycemia | |||||||||
| % Time <70 mg/dL | 3.4 (1.8, 7.1) |
1.9 (1.2, 3.1) |
2.0 (1.2, 3.7) |
<.001 | 4.1 (1.7, 8.4) |
1.7 (0.8, 3.1) |
2.1 (0.9, 4.2) |
<.001 | .90 |
| Meeting target of <4% time <70 mg/dL | 25 (56%) | 35 (78%) | 33 (77%) | .02 | 20 (48%) | 33 (79%) | 31 (74%) | .005 | .98 |
| % Time <54 mg/dL | 1.2 (0.4, 2.8) |
0.3 (0.2, 0.7) |
0.5 (0.2, 0.8) |
<.001 | 1.4 (0.2, 3.1) |
0.5 (0.1, 0.9) |
0.5 (0.1, 1.1) |
<.001 | .82 |
| Meeting target of <1% time <54 mg/dL | 20 (44%) | 34 (76%) | 34 (79%) | <.001 | 18 (43%) | 33 (79%) | 31 (74%) | .003 | .98 |
| Hypoglycemic events per week d | 1.7 (1.0, 3.1) |
0.7 (0.3, 2.0) |
1.0 (0.3, 1.5) |
<.001 | 2.3 (0.6, 3.6) |
1.0 (0.3, 2.2) |
0.9 (0.3, 1.9) |
.002 | .98 |
| HbA1c | |||||||||
| N | 45 | 45 | 45 | 42 | 42 | 42 | |||
| HbA1c | 8.3 ± 0.8 | 8.1 ± 0.8 | 8.2 ± 0.9 | .63 | 8.2 ± 0.8 | 8.2 ± 0.8 | 8.0 ± 0.9 | .20 | .82 |
Data are mean ± SD, median (IQR), or N (%).
Abbreviations: CGM, continuous glucose monitoring; FBI, family behavioral intervention; IQR, interquartile range.
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).
P-values for continuous variables are calculated from a longitudinal model of baseline, 26 weeks, and 52 weeks adjusted for baseline HbA1c and site as a random effect. P-values for binary variables are calculated from a logistic regression model at 52 weeks adjusted for baseline value of the continuous metric, baseline HbA1c, and site as a random effect.
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