Table 2.
Glycemic measures
| Measure | Participants (N = 139) | |||||
|---|---|---|---|---|---|---|
| Baseline(Days 1–15) (n = 108)Mean (SD) | 6-months(Days 194–208) (n = 108)Mean (SD) | Open Access(Days 374–388) (n = 108) Mean (SD) | Open Access % Change from Baseline | Open Access Change fromBaseline Mean (SD) | Open Access Change from Baseline p-value | |
| Time with glucose 3.9–10.0 mmol/L (70–180 mg/dL) (h) | 14.0 (4.4) | 13.6 (4.5) | 14.1 (4.0) | 0.6 | 0.1 (4.4) | 0.8519 |
| Mean Glucose (mg/dL) | 163.3 (32.7) | 175.7 (31.6) | 169.9 (27.5) | 4.0 | 6.6 (33.1) | 0.0409 |
| Mean Glucose (mmol/L) | 9.1 (1.8) | 9.8 (1.8) | 9.4 (1.5) | 4.0 | 0.4 (1.8) | 0.0409 |
| SD Glucose (mg/dL) | 55.4 (13.0) | 54.7 (13.7) | 53.7 (14.3) | −3.1 | −1.7 (11.7) | 0.1324 |
| SD Glucose (mmol/L) | 3.1 (0.7) | 3.0 (0.8) | 3.0 (0.8) | −3.1 | −0.1 (0.7) | 0.1324 |
| Glucose <3.9 mmol/L (70 mg/dL) within 24 h | ||||||
| Events | 0.67 (0.66) | 0.33 (0.36) | 0.40 (0.44) | −40.8 | −0.27 (0.67) | <0.0001 |
| Time (h) | 1.40 (1.91) | 0.47 (0.57) | 0.70 (0.94) | −49.9 | −0.70 (1.85) | 0.0002 |
| AUC (h x mg/dL) | 21.84 (37.45) | 5.21 (7.28) | 9.11 (14.70) | −58.3 | −12.73 (34.53) | 0.0002 |
| Glucose <3.9 mmol/L (70 mg/dL) at night (23.00–06.00) within 7 h | ||||||
| Events | 0.26 (0.29) | 0.13 (0.16) | 0.16 (0.22) | −37.8 | −0.10 (0.33) | 0.0021 |
| Time (h) | 0.60 (0.90) | 0.20 (0.29) | 0.28 (0.42) | −52.3 | −0.31 (0.84) | 0.0002 |
| AUC (h x mg/dL) | 10.29 (19.42) | 2.40 (4.34) | 4.07 (6.89) | −60.5 | −6.22 (17.68) | 0.0004 |
| Glucose <3.1 mmol/L (55 mg/dL) within 24 h | ||||||
| Events | 0.36 (0.53) | 0.11 (0.17) | 0.16 (0.27) | −56.5 | −0.20 (0.49) | <0.0001 |
| Time (h) | 0.65 (1.20) | 0.13 (0.22) | 0.25 (0.45) | −62.0 | −0.40 (1.09) | 0.0002 |
| AUC (h x mg/dL) | 6.54 (14.00) | 0.95 (1.81) | 2.26 (4.67) | −65.4 | −4.28 (12.76) | 0.0007 |
| Glucose <3.1 mmol/L (55 mg/dL) at night (23.00–06.00) within 7 h | ||||||
| Events | 0.16 (0.23) | 0.05 (0.09) | 0.07 (0.12) | −55.5 | −0.09 (0.21) | <0.0001 |
| Time (h) | 0.30 (0.63) | 0.06 (0.14) | 0.12 (0.22) | −62.1 | −0.19 (0.57) | 0.0008 |
| AUC (h x mg/dL) | 3.30 (7.99) | 0.48 (1.26) | 1.10 (2.40) | −66.8 | −2.21 (7.28) | 0.0021 |
| Glucose <2.5 mmol/L (45 mg/dL) within 24 h | ||||||
| Events | 0.21 (0.39) | 0.04 (0.07) | 0.08 (0.17) | −61.7 | −0.13 (0.35) | 0.0002 |
| Time (h) | 0.34 (0.79) | 0.04 (0.08) | 0.11 (0.25) | −67.2 | −0.23 (0.73) | 0.0013 |
| AUC (h x mg/dL) | 1.63 (3.96) | 0.16 (0.37) | 0.51 (1.22) | −68.5 | −1.12 (3.67) | 0.0021 |
| Glucose <2.5 mmol/L (45 mg/dL) at night (23.00–06.00) within 7 h | ||||||
| Events | 0.09 (0.18) | 0.02 (0.07) | 0.04 (0.08) | −56.0 | −0.05 (0.15) | 0.0008 |
| Time (h) | 0.17 (0.46) | 0.02 (0.07) | 0.05 (0.14) | −68.8 | −0.12 (0.42) | 0.0032 |
| AUC (h x mg/dL) | 0.88 (2.45) | 0.09 (0.31) | 0.25 (0.69) | −71.5 | −0.63 (2.26) | 0.0045 |
| Time in hyperglycemia | ||||||
| Time >10.0 mmo/L (180 mg/dL) within 24 h | 8.58 (5.84) | 9.98 (4.68) | 9.20 (4.29) | 7.2 | 0.62 (4.94) | 0.1981 |
| Time >13.3 mmo/L (240 mg/dL) within 24 h | 2.94 (3.04) | 3.54 (3.48) | 2.96 (2.81) | 0.9 | 0.03 (3.17) | 0.9533 |
| Time >16.7 mmo/L (300 mg/dL) within 24 h | 0.72 (1.45) | 1.01 (1.93) | 0.75 (1.36) | 4.3 | 0.03 (1.53) | 0.8349 |