Comparison of a Multiple Daily Insulin Injection Regimen (Basal Once-Daily Glargine Plus Mealtime Lispro) and Continuous Subcutaneous Insulin Infusion (Lispro) in Type 1 Diabetes A randomized open parallel multicenter study
Comparison of a Multiple Daily Insulin Injection Regimen (Basal Once-Daily Glargine Plus Mealtime Lispro) and Continuous Subcutaneous Insulin Infusion (Lispro) in Type 1 Diabetes A randomized open parallel multicenter study
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DOI：
10.2337/dc08-1874
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发表时间：
2009-07-01
期刊：
影响因子：
16.2
通讯作者：
Home, Philip D.
中科院分区：
文献类型：
--
作者：
Bolli, Geremia B.;Kerr, David;Home, Philip D.
目的：在一项多中心研究中，尚未对胰岛素泵治疗（连续皮下胰岛素输注[CSII]）和每日多次注射（MDI）甘精胰岛素作为基础胰岛素和餐时赖脯胰岛素在未接受过任一方案的患者中进行前瞻性比较。研究设计和方法-接受NPH为基础的胰岛素治疗的1型糖尿病患者随机接受CSII或甘精胰岛素为基础的MDI（均使用赖脯胰岛素），并采用等效设计随访24周。50人被正确地随机化，43人完成了研究。结果-在终点的总胰岛素需求量（平均值+/- SD）在CSII为36.2 +/- 11.5单位/天，MDI为42.6 +/- 15.5单位/天。两组的平均A1 C下降相似（CSII-0. 7 +/-0. 7%; MDI-0. 6 +/-0. 8%），基线校正差异为-0. 1%（95% CI-0. 5 - 0. 3）。同样，空腹血糖和其他餐前、餐后和夜间自我监测的血糖水平在两种治疗方案之间没有差异，血糖变异性的测量也没有差异。在CSII中，28名参与者中的23名（82%）记录了1，152起低血糖事件，MDI组29名患者中的27名（93%）记录了1，022起低血糖事件（所有低血糖差异均无显著性）。CSII组的治疗满意度评分增加更多;然而，各组的评分变化相似。CSII.CONCLUSIONS -在未接受CSII或甘精胰岛素治疗的I型糖尿病患者中，与基于甘精胰岛素的MDI治疗相比，更昂贵的CSII治疗的血糖控制并没有更好。
OBJECTIVE - Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) and multiple daily injections (MDIs) with insulin glargine as basal insulin and mealtime insulin lispro have not been prospectively compared in people naive to either regimen in a multicenter study. We aimed to help close that deficiency.RESEARCH DESIGN AND METHODS - People with type 1 diabetes on NPH-based insulin therapy were randomized to CSII or glargine-based MDI (both otherwise using lispro) and followed for 24 weeks in an equivalence design. Fifty people were correctly randomized, and 43 completed the study.RESULTS - Total insulin requirement (mean +/- SD) at end point was 36.2 +/- 11.5 units/day on CSII and 42.6 +/- 15.5 units/day on MDI. Mean A1C fell similarly in the two groups (CSII -0.7 +/- 0.7%; MDI -0.6 +/- 0.8%) with a baseline-adjusted difference of -0.1% (95% CI -0.5 to 0.3). Similarly, fasting blood glucose and other preprandial, postprandial, and nighttime self-monitored plasma glucose levels did not differ between the regimens, nor did measures of plasma glucose variability. On CSII, 1,152 hypoglycemia events were recorded by 23 of 28 participants (82%) and 1,022 in the MDI group by 27 of 29 patients (93%) (all hypoglycemia differences were nonsignificant). Treatment satisfaction score increased more with CSII; however, the change in score was similar for the groups. Costs were similar to 3.9 times higher for CSII.CONCLUSIONS - In unselected people with type I diabetes naive to CSII or insulin glargine, glycemic control is no better with the more expensive CSII therapy compared with glargine-based MDI therapy.