Table 3.
Secondary CGM-measured glucose end points
| Baseline (2 weeks) | Postrandomization (final 11 weeks) | |||||
|---|---|---|---|---|---|---|
| CLC (n = 63)† | SAP (n = 61)† | CLC (n = 64)† | SAP (n = 61)† | Risk-adjusted difference (90% CI)‡ | P value‡ | |
| Hours of sensor data, median (IQR) | 304 (267, 323) | 311 (294, 322) | 1,656 (1,464, 1,781) | 1,683 (1,565, 1,780) | NA | NA |
| Hypoglycemia | ||||||
| CGM-measured % below 54 mg/dL (3.0 mmol/L), median (IQR) | 1.1 (0.3, 2.1) | 0.9 (0.2, 1.9) | 0.5 (0.2, 0.8) | 0.6 (0.2, 1.4) | ||
| Mean ± SD | 1.7 ± 2.0 | 1.6 ± 2.4 | 0.6 ± 0.6 | 1.1 ± 1.2 | −0.5 (−0.8, −0.2) | 0.0009 |
| CGM-measured % below 60 mg/dL (3.3 mmol/L), median (IQR) | 2.0 (0.6, 3.8) | 1.7 (0.6, 3.1) | 0.9 (0.4, 1.4) | 1.2 (0.5, 2.4) | ||
| Mean ± SD | 2.8 ± 2.8 | 2.6 ± 3.3 | 1.1 ± 1.0 | 1.9 ± 1.9 | −0.8 (−1.3, −0.4) | 0.0003 |
| CGM-measured LBGI, median (IQR) | 1.0 (0.6, 1.7) | 0.9 (0.4, 1.5) | 0.6 (0.4, 0.9) | 0.8 (0.5, 1.4) | ||
| Mean ± SD | 1.3 ± 1.0 | 1.2 ± 1.2 | 0.7 ± 0.4 | 1.0 ± 0.8 | −0.4 (−0.6, −0.2) | <0.0001 |
| CGM-measured hypoglycemic events,a median (IQR) | 5.9 (3.5, 9.2) | 5.5 (2.6, 8.3) | 4.2 (2.5, 6.3) | 4.8 (3.1, 8.2) | ||
| Mean ± SD | 6.5 ± 4.3 | 5.7 ± 4.0 | 4.5 ± 2.7 | 5.9 ± 4.0 | −1.9 (−2.9, −1.0) | <0.0001 |
| Overall control | ||||||
| Glucose (mg/dL), mean ± SD | 172 ± 30 | 177 ± 33 | 166 ± 19 | 170 ± 28 | −1.3 (−7.8, 5.2) | 0.82 |
| CGM-measured % in range 70–180 mg/dL (3.9–10 mmol/L), mean ± SD | 55 ± 16 | 53 ± 16 | 64 ± 11 | 57 ± 14 | 4.8 (1.4, 8.3) | 0.0074 |
| CGM-measured % in range 3.9–7.8 mmol/L (70–140 mg/dL), mean ± SD | 34 ± 14 | 32 ± 14 | 39 ± 10 | 35 ± 12 | 3.0 (0, 6.0) | 0.1047 |
| CGM-measured CV (%), median (IQR) | 39 (34, 44) | 39 (35, 43) | 37 (34, 41) | 38 (35, 42) | ||
| Mean ± SD | 39 ± 7 | 39 ± 7 | 37 ± 5 | 38 ± 5 | −1.0 (−2.5, 0.5) | 0.67 |
| Hyperglycemia | ||||||
| CGM-measured % above 250 mg/dL (13.9 mmol/L), median (IQR) | 13.5 (5.0, 23.7) | 13.9 (6.8, 26.6) | 10.9 (5.3, 15.7) | 11.3 (5.0, 17.3) | ||
| Mean ± SD | 15.4 ± 11.8 | 17.5 ± 12.8 | 11.2 ± 7.4 | 13.7 ± 11.4 | −1.2 (−4.0, 1.6) | 0.82 |
| CGM-measured % above 300 mg/dL (16.7 mmol/L), median (IQR) | 4.4 (1.3, 12.3) | 5.7 (1.5, 12.0) | 3.4 (1.5, 6.1) | 3.2 (1.1, 6.9) | ||
| Mean ± SD | 6.8 ± 6.6 | 8.0 ± 8.2 | 4.4 ± 4.2 | 5.7 ± 7.1 | −0.4 (−2.1, 1.3) | 0.82 |
| CGM-measured HBGI, median (IQR) | 9.1 (5.6, 13.5) | 9.6 (6.6, 14.0) | 8.2 (5.9, 9.9) | 8.6 (6.1, 10.6) | ||
| Mean ± SD | 9.9 ± 5.0 | 10.8 ± 5.6 | 8.2 ± 3.3 | 9.3 ± 4.9 | −0.6 (−1.7, 0.6) | 0.82 |
CV, coefficient of variation; HBGI, high BG index; NA, not applicable.
†
Excludes one participant from the CLC group and one participant from the SAP group who dropped out postrandomization and did not have any data 3–13 weeks postrandomization to be included in analyses. The baseline CGM data for another CLC participant were unavailable, so their follow-up CGM data were included in both models using the direct likelihood method.
‡
Adjusted for baseline values, age, prior CGM use, and clinical center (random effects). P values and CIs adjusted for multiplicity using the false discovery rate, with 0.10 as the threshold for statistical significance.
a
At least 15 consecutive min <70 mg/dL.