Table 2.
Comparison of subjects suffering from at least a single episode of HYPO (severe and symptomatic) in the various 6-month periods between groups, and at different time points, defined as: A = T−6/T0 (pre-randomization period); B = T0/T+6 (first follow-up period); C = T+6/T+12 (second follow-up period)
| Severe HYPOs | Symptomatic HYPOs | |||||
|---|---|---|---|---|---|---|
| Control group n. 318 |
Intervention group n. 395 |
p | Control group n. 318 |
Intervention group n. 395 |
p | |
|
T−6/T0 (A baseline) n. (%) |
55 (17.31) |
58 (14.72) |
n.s. |
218 (68.52) |
279 (70.91) |
n.s. |
|
T0/T+6 (B period) n (%) |
49 (15.41) |
25* (6.32) |
< 0.001 |
207 (65.93) |
34** (8.61) |
< 0.0001 |
|
T+6/T+12 (C period) n (%) |
48 (15.11) |
5**& (3.81) |
< 0.0001 |
215 (67.62) |
11**& (2.73) |
< 0.00001 |
| *p vs. T−6/T0 | n.s. | < 0.0001 | n.s. | < 0.0001 | ||
| &p vs. T0/T+6 | n.s. | < 0.0001 | n.s. | < 0.0001 | ||