Table 2.
Hypoglycaemia | Day‐to‐day fasting SMBG variability tertile | Patients with T1D | Patients with T2D | ||
---|---|---|---|---|---|
Estimate [95% CI] | P‐value | Estimate [95% CI] | P‐value | ||
Overall symptomatic | Low | 0.68 [0.58; 0.78] | P < 0.0001 | 0.28 [0.20; 0.40] | P < 0.0001 |
Medium | Reference | Reference | |||
High | 1.32 [1.19; 1.46] | 2.23 [1.79; 2.78] | |||
Nocturnal symptomatic | Low | 0.45 [0.33; 0.62] | P < 0.0001 | 0.18 [0.09; 0.36] | P < 0.0001 |
Medium | Reference | Reference | |||
High | 1.59 [1.26; 2.01] | 2.18 [1.56; 3.03] | |||
Severe | Low | 0.82 [0.49; 1.38] | P = 0.0053 | 0.33 [0.09; 1.22] | P = 0.1140 |
Medium | Reference | Reference | |||
High | 1.70 [1.11; 2.61] | 1.31 [0.55; 3.09] |
Abbreviations: CI, confidence interval; SMBG, self‐monitored blood glucose; T1D, type 1 diabetes; T2D, type 2 diabetes.
Data were based on the full analysis set. Number of episodes was analysed using a Poisson Model with logarithm of exposure time (100 years) as offset. The model included treatment, period, sequence, dosing time and SMBG as fixed effects, and participant as a random effect. SMBG was incorporated as a factor with three tertiles of the fasting SMBG variability, defined by the tertiles the square root of the mean value of the weekly variances of fasting SMBG values across the 16 weeks during the maintenance period.