Glycemic control after 6 days of insulin pump reservoir use in type 1 diabetes: Results of double‐blind and open‐label cross‐over trials of insulin lispro and insulin aspart 1型糖尿病患者连续使用胰岛素泵6天后的血糖控制情况：赖脯胰岛素与门冬胰岛素的双盲、开放标签、交叉试验

Background The objective of the current study was to assess mean self‐monitored blood glucose ( SMBG ), on day 6 of 6 days of continuous reservoir wear (6 D ), with insulin lispro ( L is) or insulin aspart ( A sp). Methods Two 24‐week, randomized trials were conducted in subjects with type 1 diabetes treated by continuous subcutaneous insulin infusion ( CSII ) for ≥6 months, with a mean total daily insulin dose capable of supporting 6 days of in‐reservoir use. Study 1 had an open‐label, six‐sequence, three‐treatment, three‐period, cross‐over design. Study 2 had a double‐blind, two‐sequence, two‐treatment, two‐period, cross‐over design. The primary efficacy measure was the mean of Day 6, seven‐point SMBG profiles for insulin lispro 6 D ( L is6 D ) and insulin aspart 6 D ( A sp6 D ) treatment periods. Safety measures were also assessed. Results Lis did not achieve noninferiority ( SMBG ; margin = 0.6 mmol/L [10.8 mg/dL]) to A sp on D ay 6 of reservoir wear in either Study (least‐squares mean difference: Study 1 = 0.48 mmol/L [8.64 mg/dL]; 95% confidence interval [ CI ] [0.20, 0.76], Study 2 = 0.36 mmol/L [6.49 mg/dL]; 95% CI [0.06, 0.66]). Noninferiority was demonstrated for overall daily mean of SMBG values over days 1 to 6 of reservoir use during each treatment period. In the L is treatment period, subjects reported a lower documented and total hypoglycemia rate per 30 days and a higher rate of non‐explained hyperglycemia than in the A sp treatment period. Conclusion While the mean blood glucose on Day 6 of L is6 D did not meet non‐inferiority, the overall daily mean blood glucose was not different, with a decreased rate of hypoglycemia with L is.