Sensor-augmented insulin pump therapy: Results of the first randomized treat-to-target study
Sensor-augmented insulin pump therapy: Results of the first randomized treat-to-target study
复制标题
DOI：
10.1089/dia.2008.0068
复制
发表时间：
2008-10-01
影响因子：
5.4
通讯作者：
Buckingham, Bruce A.
中科院分区：
文献类型：
--
作者：
Hirsch, Irl B.;Abelseth, Jill;Buckingham, Bruce A.
背景资料：本研究的目的是评价将胰岛素泵与实时动态血糖监测（CGM）相结合的器械与使用胰岛素泵与标准血糖监测系统相比较的临床有效性和安全性。方法：这项为期6个月、随机、多中心、一项达标治疗研究招募了146名年龄在12岁至72岁之间的1型糖尿病患者，他们接受了持续皮下胰岛素输注治疗，初始A1 C水平>= 7.5%。受试者被随机分配接受实时CGM泵治疗（探头组[SG]）或仅接受泵治疗和自我血糖监测（对照组[CG]）。结果：两组A1 C水平均较基线（8.44 ± 0.70%）下降（P < 0.001）（SG，-0.71 ± 0.71%; CG，-0.56 ± 0.072%）;然而，组间差异无显著性。SG受试者的平均低血糖曲线下面积（AUC）未发生变化，而CG受试者在研究设盲期间的低血糖AUC增加（P = 0.001）。低血糖AUC的组间差异显著（P < 0.0002）。探头利用率超过60%与A1 C降低相关（P = 0.0456）。发生14例严重低血糖事件（SG组11例，CG组3例，P = 0.04）。CG组受试者在盲态CGM使用期间的低血糖AUC和事件数量增加;但是，SG组的低血糖AUC或事件数量未增加。探头使用率较高的受试者A1 C水平改善较大。
Background: The objective of the study was to evaluate the clinical effectiveness and safety of a device that combines an insulin pump with real-time continuous glucose monitoring (CGM), compared to using an insulin pump with standard blood glucose monitoring systems.Methods: This 6-month, randomized, multicenter, treat-to-target study enrolled 146 subjects treated with continuous subcutaneous insulin infusion between the ages of 12 and 72 years with type 1 diabetes and initial A1C levels of >= 7.5%. Subjects were randomized to pump therapy with real-time CGM (sensor group [SG]) or to pump therapy and self-monitoring of blood glucose only (control group [CG]). Clinical effectiveness and safety were evaluated.Results: A1C levels decreased (P < 0.001) from baseline (8.44 +/- 0.70%) in both groups (SG, -0.71 +/- 0.71%; CG, -0.56 +/- 0.072%); however, between-group differences did not achieve significance. SG subjects showed no change in mean hypoglycemia area under the curve (AUC), whereas CG subjects showed an increase (P = 0.001) in hypoglycemia AUC during the blinded periods of the study. The between-group difference in hypoglycemia AUC was significant (P < 0.0002). Greater than 60% sensor utilization was associated with A1C reduction (P = 0.0456). Fourteen severe hypoglycemic events occurred (11 in the SG group and three in the CG group, P = 0.04).Conclusions: A1C reduction was no different between the two groups. Subjects in the CG group had increased hypoglycemia AUC and number of events during blinded CGM use; however, there was no increase in hypoglycemia AUC or number of events in the SG group. Subjects with greater sensor utilization showed a greater improvement in A1C levels.