Table 3:
Glycemic data before and after lumacaftor-ivacaftor in Males vs Females
| Males Pre-lumacaftor-ivacaftor, n=6 | Males Post-lumacaftor-ivacaftor, n=6 | Wilcoxon P-value | Females Pre-lumacaftor-ivacaftor, n=3 | Females Post-lumacaftor-ivacaftor, n=3 | Wilcoxon P-value | |
|---|---|---|---|---|---|---|
| HbA1c, % | 5.2 (5.0,5.2) | 5.4 (5.2,5.5) | 0.04 | 5.5 (5.5,5.6) | 5.6 (5.6,5.9) | 0.59 |
| OGTT status, n (%) | ||||||
| NGT | 2 (17) | 3 (50) | 1 (33) | 0 (0) | ||
| AGT | 3 (33) | 3 (50) | 2 (33) | 2 (67) | ||
| CFRD | 1 (50) | 0 (0) | 0 (33) | 1 (33) | ||
| OGTT, fasting, mg/dl | 84 (77, 93) | 94 (92,108) | 0.06 | 99 (94, 100) | 100 (97,106) | 0.25 |
| OGTT, 1 hour, mg/dl | 163 (161,189) | 188 (171,239) | 0.31 | 198 (172, 200) | 248 (247, 250) | 0.17 |
| OGTT, 2 hour, mg/dl | 152 (125,165) | 128 (117, 135) | 0.56 | 109 (106,125) | 152 (149,183) | 0.25 |
| CGM variables | ||||||
| Average sensor glucose, mg/dl | 113 (106, 120) | 110 (104, 117) | 0.69 | 116 (111, 124) | 119 (117,124) | 0.75 |
| Minimum sensor glucose, mg/dl | 61 (45, 66) | 68 (61, 72) | 0.22 | 73 (71, 74) | 67 (54, 74) | 0.75 |
| Maximum sensor glucose, mg/dl | 249 (192, 265) | 203 (172, 214) | 0.06 | 186 (183, 238) | 213 (203,272) | 0.75 |
| % time over 120 mg/dl | 29 (21, 38) | 29 (17, 33) | 0.56 | 38 (26, 42) | 40 (36, 47) | 0.75 |
| % time over 140 mg/dl | 14 (6, 18) | 8 (4, 14) | 0.44 | 8 (5, 19) | 14 (13, 23) | 0.75 |
| % time over 200 mg/dl | 1.33 (0.25,1.93) | 0.06 (0,0.29) | 0.10 | 0 (0,3.96) | 0.46 (0.23,2.46) | 1 |
| Average # excursions over 140 mg/dl per day | 3 (2, 4) | 3 (2, 4) | 1 | 2 (2,3) | 4 (3, 4) | 0.5 |
| Average # excursions over 200 mg/dl per day | 0.5 (0.1, 0.8) | 0.2 (0.0, 0.2) | 0.36 | 0 (0,1) | 0.3 (0.2,1.1) | 1 |
| % time under 60 mg/dl | 0 (0,1.4) | 0 (0,0) | 0.42 | 0 (0,0) | 0 (0,2.6) | 1 |
| % time under 70 mg/dl | 0.7 (0.2,2.0) | 0.1 (0, 1.1) | 0.44 | 0 (0,0) | 0 (0, 4) | 1 |
| Average area under curve/day | 1.6 ×105 (1.5 ×105 1.7×105) | 1.6×105 (1.5×105, 1.7×105) | 0.69 | 1.7×105 (1.6×105, 1.8×105) | 1.7×105 (1.7×105, 1.8×105) | 0.75 |
| Standard deviation | 29 (19,31) | 21(17,26) | 0.06 | 16(16, 28) | 22 (21, 32) | 0.75 |
| Mean amplitude of glycemic excursion | 67 (47,72) | 52 (36, 62) | 0.03 | 37 (34,61) | 50 (45, 70) | 0.75 |
| Clinical measures | ||||||
| Forced vital capacity (%) | 100.5 (95.5,105.5) | 97 (89.75,101.25) | 0.25 | 122 (113,123) | 121 (110,121) | 0.25 |
| Forced expiratory volume in 1 sec (%) | 95.5 (93.5,96) | 95.5 (86.5,105.25) | 1 | 110 (110,110.5) | 108 (102.5,114) | 0.75 |
| Weight z-score | −0.62 (−1.22,−0.07) | −0.5 (−1.12,0.14) | 0.22 | −0.25 (−0.32,0.3) | 0.14 (−0.26,0.45) | 1 |
| BMI z-score | −0.62 (−1.23,−0.18) | −0.37 (−1.24,0.24) | 0.44 | −0.29 (−0.48,0.14) | 0.39 (−0.27,0.47) | 1 |
Data presented as Median (25th%ile, 75th%ile) unless otherwise specified
Abbreviations: OGTT=oral glucose tolerance test; NGT= normal glycemic tolerance; AGT= abnormal glycemic tolerance; CFRD=cystic fibrosis related diabetes; CGM=continuous glucose monitoring; BMI=body mass index