Table 3.
Hypoglycaemia | Day‐to‐day fasting SMBG variability (CV%) tertile | Patients with T1D | Patients with T2D | ||
---|---|---|---|---|---|
Estimate [95% CI] | P value | Estimate [95% CI] | P value | ||
Overall symptomatic | Low | 0.69 [0.61; 0.78] | P < 0.0001 | 0.31 [0.22; 0.44] | P < 0.0001 |
Medium | Reference | Reference | |||
High | 1.18 [1.07; 1.30] | 2.09 [1.67; 2.61] | |||
Nocturnal symptomatic | Low | 0.44 [0.33; 0.59] | P < 0.0001 | 0.26 [0.14; 0.47] | P < 0.0001 |
Medium | Reference | Reference | |||
High | 1.34 [1.08; 1.67] | 2.05 [1.48; 2.84] | |||
Severe | Low | 0.59 [0.35; 0.98] | P = 0.0106 | 0.68 [0.22; 2.11] | P = 0.2705 |
Medium | Reference | Reference | |||
High | 1.28 [0.86; 1.90] | 1.59 [0.65; 3.93] |
Abbreviations: CI, confidence interval; CV, coefficient of variation; 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 the 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 geometric mean value of the weekly CV% of fasting SMBG values across the 16 weeks during the maintenance period.