Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial
Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial
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DOI：
10.1007/s00125-009-1365-0
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发表时间：
2009-07-01
期刊：
影响因子：
8.2
通讯作者：
Cameron, F. J.
中科院分区：
文献类型：
--
作者：
O'Connell, M. A.;Donath, S.;Cameron, F. J.
本研究的目的是评估以患者为主导的传感器引导泵管理对血糖控制的影响，并与标准胰岛素泵治疗的效果进行比较。年龄在13.0-40.0岁之间的1型糖尿病患者以1：1的比例随机分配至任一研究组，为期3个月。使用中央计算机生成的时间表进行随机化。干预组的参与者使用传感器引导的泵管理;未提供解释实时数据的指导性指南（“患者引导”使用）。对照组的参与者继续他们最初的胰岛素泵方案。动态血糖监测（CGM）和糖化血红蛋白（HbA 1c）水平用于评估结果。主要结局是3个月研究期间目标血糖范围内的时间比例差异（来自CGM，目标范围4-10 mmol/l）。次要结局是HbA（1c）、低血糖时间和低血糖发生率的差异。（千分之一货币符号3.9 mmol/l）和高血压（千分之一日元10.1 mmol/l）范围和血药浓度变异性。分别有5/31和2/31人退出干预组和对照组，剩下26/31和29/31人进行意向治疗分析。当调整基线值时，干预组的平均研究结束HbA（1c）比对照组低0.43%（95% CI 0.19 - 0.75%; p = 0.009）。在目标（测量差异1.72; 95% CI -5.37至8.81）、低血糖（0.54; 95% CI -3.48至4.55）或高血糖（-2.18; 95% CI -10.0至5.69）范围内的CGM推导时间或血糖变异性（-0.29; 95% CI -0.34至0.28）方面未观察到差异。在干预组中，与传感器使用< 70%的参与者相比，传感器使用<70%的参与者的HbA（1c）低0.51%（95% CI -0.98至-0.04，p = 0.04）。发生了五次设备故障。接受胰岛素泵治疗的患者可以采用传感器引导的泵管理来改善血糖控制。注意到传感器使用的明显剂量依赖性效应;然而，频繁使用该技术（千分之一日元70%）并不是普遍可接受的。试验注册：ACTRN 12606000049572资金：由Medtronic Australasia提供资金支持和设备。
The objective of this study was to assess the impact of patient-led sensor-guided pump management on glycaemic control, and compare the effect with that of standard insulin pump therapy.An open multicentre parallel randomised controlled trial was conducted at five tertiary diabetes centres. Participants aged 13.0-40.0 years with well-controlled type 1 diabetes were randomised 1:1 to either study group for 3 months. Randomisation was carried out using a central computer-generated schedule. Participants in the intervention group used sensor-guided pump management; no instructive guidelines in interpreting real-time data were provided ('patient-led' use). Participants in the control group continued their original insulin pump regimen. Continuous glucose monitoring (CGM) and HbA(1c) level were used to assess outcomes. The primary outcome was the difference in the proportion of time in the target glycaemic range during the 3 month study period (derived from CGM, target range 4-10 mmol/l). Secondary outcomes were difference in HbA(1c), time in hypoglycaemic (a parts per thousand currency sign3.9 mmol/l) and hyperglycaemic (a parts per thousand yen10.1 mmol/l) ranges and glycaemic variability.Sixty-two participants were recruited and randomised; 5/31 and 2/31 withdrew from intervention and control groups, respectively, leaving 26/31 and 29/31 for the intention-to-treat analyses. When adjusted for baseline values, the mean end-of-study HbA(1c) was 0.43% lower in the intervention group compared with the control group (95% CI 0.19 to 0.75%; p = 0.009). No difference was observed in CGM-derived time in target (measured difference 1.72; 95% CI -5.37 to 8.81), hypoglycaemic (0.54; 95% CI -3.48 to 4.55) or hyperglycaemic (-2.18; 95% CI -10.0 to 5.69) range or in glycaemic variability (-0.29; 95% CI -0.34 to 0.28). Within the intervention group, HbA(1c) was 0.51% lower in participants with sensor use a parts per thousand yen70% compared with participants with sensor use < 70% (95% CI -0.98 to -0.04, p = 0.04). Five episodes of device malfunction occurred.Individuals established on insulin pump therapy can employ sensor-guided pump management to improve glycaemic control. An apparent dose-dependent effect of sensor usage was noted; however, frequent use of this technology (a parts per thousand yen70%) was not universally acceptable.Trial registration: ACTRN12606000049572Funding: Funding support and equipment were provided by Medtronic Australasia.