Table 2.
Analysis of Daily and Nocturnal Percent of Time and Episodes with Low Glucose Levels (Full Analysis Set Population)
| CGM (DexCom G4) | Conventional therapy | Mean (95% CI) for difference CGM-conventional treatment | P | |
|---|---|---|---|---|
| Percent of time with low glucose levels (measured by CGM during 2 weeks) below 70 mg/dL [3.9 mmol/L] | ||||
| Daytime 06:00–23:59 | 2.73 (2.18–3.28) | 4.52 (3.82–5.22) | −1.77 (−2.47 to −1.06) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Nighttime 00:00–05:59 | 2.82 (2.19–3.46) | 5.45 (4.19–6.72) | −2.63 (−3.90 to −1.36) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Daytime 06:00–21:59 | 2.81 (2.25–3.36) | 4.77 (4.02–5.53) | −1.93 (−2.69 to −1.17) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Nighttime 22:00–05:59 | 2.63 (2.04–3.22) | 4.74 (3.70–5.77) | −2.11 (−3.14 to −1.07) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Percent of time with low glucose levels (measured by CGM during 2 weeks) below 54 mg/dL [3.0 mmol/L] | ||||
| Daytime 06:00–23:59 | 0.76 (0.54–0.98) | 1.67 (1.32–2.03) | −0.92 (−1.25 to −0.59) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Nighttime 00:00–05:59 | 0.85 (0.54–1.16) | 2.46 (1.74–3.18) | −1.62 (−2.37 to −0.87) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Daytime 06:00–21:59 | 0.77 (0.55–0.99) | 1.77 (1.39–2.15) | −1.00 (−1.37 to −0.64) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Nighttime 22:00–05:59 | 0.80 (0.52–1.08) | 2.08 (1.50–2.67) | −1.29 (−1.90 to −0.68) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Number of low glucose episodes (measured by CGM during 2 weeks) below 70 mg/dL [3.9 mmol/L] | ||||
| Whole period | 11.45 (9.99–12.90) | 13.51 (12.07–14.96) | −2.06 (−3.65 to −0.46) | 0.01 |
| n = 123 | n = 125 | n = 123 | ||
| Daytime 06:00–23:59 | 9.46 (8.21–10.70) | 11.78 (10.45–13.12) | −2.30 (−3.73 to −0.87) | 0.002 |
| n = 123 | n = 125 | n = 123 | ||
| Nighttime 00:00–05:59 | 2.57 (2.09–3.05) | 2.92 (2.42–3.42) | −0.36 (−0.94–0.22) | 0.23 |
| n = 123 | n = 125 | n = 123 | ||
| Daytime 06:00–21:59 | 8.85 (7.69–10.02) | 11.02 (9.73–12.30) | −2.13 (−3.52 to −0.74) | 0.003 |
| n = 123 | n = 125 | n = 123 | ||
| Nighttime 22:00–05:59 | 3.25 (2.69–3.81) | 3.75 (3.19–4.31) | −0.50 (−1.16–0.15) | 0.13 |
| n = 123 | n = 125 | n = 123 | ||
| Number of low glucose episodes (measured by CGM during 2 weeks) below 54 mg/dL [3.0 mmol/L] | ||||
| Whole period | 4.38 (3.56–5.21) | 6.84 (5.83–7.85) | −2.46 (−3.45 to −1.47) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Daytime 06:00–23:59 | 3.50 (2.81–4.20) | 5.58 (4.73–6.42) | −2.07 (−2.94 to −1.19) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Nighttime 00:00–05:59 | 1.03 (0.77–1.30) | 1.76 (1.32–2.20) | −0.74 (−1.20 to −0.28) | 0.002 |
| n = 123 | n = 125 | n = 123 | ||
| Daytime 06:00–21:59 | 3.25 (2.61–3.89) | 5.17 (4.35–5.99) | −1.90 (−2.74 to −1.06) | <0.001 |
| n = 123 | n = 125 | n = 123 | ||
| Nighttime 22:00–05:59 | 1.33 (1.00–1.67) | 2.14 (1.68–2.61) | −0.83 (−1.32 to −0.34) | 0.001 |
| n = 123 | n = 125 | n = 123 | ||
For continuous variables, mean, 95% CI, and n are presented. Fisher's nonparametric permutation test for crossover design was used.