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Table 3—

Outcome measures (pairwise comparisons) using insulin detemir or NPH insulin as basal insulin therapy in type 1 diabetes

MeasureGroup 1Group 2Mean difference (95% CI)P
HbA1c (%) IDetcombined NPH −0.2 (−0.34 to −0.02) 0.027 
Clinic FPG (mmol/l) IDet12h NPH −1.5 (−2.51 to −0.48) 0.004 
 IDetmorn+bed NPH −2.3 (−3.32 to −1.29) <0.001 
 IDet12h IDetmorn+bed 0.8 (−0.18 to 1.80) NS 
Self-monitored fasting blood glucose     
 Mean IDet12h NPH −0.8 (−1.32 to −0.22) 0.006 
 IDetmorn+bed NPH −0.8 (−1.34 to −0.25) 0.004 
 IDet12h IDetmorn+bed 0.0 (−0.51 to 0.56) NS 
 Within-patient SD* IDet12h NPH  <0.001 
 IDetmorn+bed NPH  <0.001 
 IDet12h IDetmorn+bed  NS 
Body weight change (kg) IDet12h NPH −0.8 (−1.44 to −0.24) 0.006 
 IDetmorn+bed NPH −0.6 (−1.23 to −0.03) 0.040 
 IDet12h IDetmorn+bed −0.2 (−0.80 to 0.37) NS 
CGMS glucose profiles deviation from average (mmol/l · h)     
 >24 h IDetcombined NPH −6.45 (−13.3 to 0.40) 0.065 
 Overnight IDetcombined NPH −1.72 (−4.05 to −0.62) NS 
Hypoglycemia in final 12 weeks [RR (95% CI)]     
 Minor-any time IDet12h NPH 0.75 (0.56–1.00) 0.046 
 IDetmorn+bed NPH 0.68 (0.56–0.84) 0.002 
 Minor-nocturnal IDet12h NPH 0.74 (0.50–1.08) NS 
 IDetmorn+bed NPH 0.47 (0.36–0.62) <0.001 
MeasureGroup 1Group 2Mean difference (95% CI)P
HbA1c (%) IDetcombined NPH −0.2 (−0.34 to −0.02) 0.027 
Clinic FPG (mmol/l) IDet12h NPH −1.5 (−2.51 to −0.48) 0.004 
 IDetmorn+bed NPH −2.3 (−3.32 to −1.29) <0.001 
 IDet12h IDetmorn+bed 0.8 (−0.18 to 1.80) NS 
Self-monitored fasting blood glucose     
 Mean IDet12h NPH −0.8 (−1.32 to −0.22) 0.006 
 IDetmorn+bed NPH −0.8 (−1.34 to −0.25) 0.004 
 IDet12h IDetmorn+bed 0.0 (−0.51 to 0.56) NS 
 Within-patient SD* IDet12h NPH  <0.001 
 IDetmorn+bed NPH  <0.001 
 IDet12h IDetmorn+bed  NS 
Body weight change (kg) IDet12h NPH −0.8 (−1.44 to −0.24) 0.006 
 IDetmorn+bed NPH −0.6 (−1.23 to −0.03) 0.040 
 IDet12h IDetmorn+bed −0.2 (−0.80 to 0.37) NS 
CGMS glucose profiles deviation from average (mmol/l · h)     
 >24 h IDetcombined NPH −6.45 (−13.3 to 0.40) 0.065 
 Overnight IDetcombined NPH −1.72 (−4.05 to −0.62) NS 
Hypoglycemia in final 12 weeks [RR (95% CI)]     
 Minor-any time IDet12h NPH 0.75 (0.56–1.00) 0.046 
 IDetmorn+bed NPH 0.68 (0.56–0.84) 0.002 
 Minor-nocturnal IDet12h NPH 0.74 (0.50–1.08) NS 
 IDetmorn+bed NPH 0.47 (0.36–0.62) <0.001 

Pairwise testing was only performed where allowed by the protocol (see research design and methods); accordingly only limited comparisons are given.

*

Data distribution did not allow calculation of mean difference and CIs for within-patient variability;

estimates of the relative risk of hypoglycemic episodes during the maintenance period calculated using a recurrent event γ-frailty model. IDetcombined, insulin detemir groups combined.

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