传感器增强型泵治疗可降低血糖控制不佳的 1 型糖尿病患者的 HbA(1c)；一项随机对照试验。
Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial.
机构信息
Department of Internal Medicine, Academic Medical Centre, Amsterdam, The Netherlands.
出版信息
Diabet Med. 2011 Oct;28(10):1158-67. doi: 10.1111/j.1464-5491.2011.03256.x.
AIMS
To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes.
METHODS
In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18-65 years and HbA(1c) ≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm(®) REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA(1c) between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed.
RESULTS
The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA(1c) at baseline and at 26 weeks changed from 8.46% (SD 0.95) (69 mmol/mol) to 7.23% (SD 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (SD 0.82) (70 mmol/mol) to 8.46% (SD 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA(1c) after 26 weeks was -1.21% (95% confidence interval -1.52 to -0.90, P < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, P = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (P = 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group.
CONCLUSIONS
Sensor augmented pump therapy effectively lowers HbA(1c) in patients with Type 1 diabetes suboptimally controlled with multiple daily injections.
目的
研究在血糖控制不佳的 1 型糖尿病患者中，传感器增强型泵治疗与多次皮下注射治疗的疗效。
方法
在这项由研究者发起的、在欧洲 8 个门诊中心进行的多中心试验（Eurythmics 试验）中，我们将 83 名目前接受多次皮下注射治疗、年龄在 18-65 岁之间、糖化血红蛋白（HbA1c）≥8.2%（≥66mmol/mol）的 1 型糖尿病患者（40 名女性）随机分为 26 周的治疗组，分别接受传感器增强型胰岛素泵（n=44）（Paradigm®REAL-Time）或继续接受多次皮下注射治疗（n=39）。评估基线和 26 周时的 HbA1c 变化、传感器衍生终点和患者报告的结果。
结果
传感器增强型胰岛素泵组有 44 名患者中的 43 名（98%）和多次皮下注射组有 39 名患者中的 35 名（90%）完成了试验。传感器增强型胰岛素泵组基线和 26 周时的平均 HbA1c 从 8.46%（标准差 0.95）（69mmol/mol）降至 7.23%（标准差 0.65）（56mmol/mol），多次皮下注射组从 8.59%（标准差 0.82）（70mmol/mol）降至 8.46%（标准差 1.04）（69mmol/mol）。26 周后 HbA1c 变化的平均差值为-1.21%（95%置信区间-1.52 至-0.90，P<0.001），有利于传感器增强型胰岛素泵组。这是在不增加低血糖时间百分比的情况下实现的：组间差异 0.0%（95%置信区间-1.6 至 1.7，P=0.96）。传感器增强型胰岛素泵组有 4 例严重低血糖发作，多次皮下注射组有 1 例（P=0.21）。传感器增强型胰岛素泵组的糖尿病问题领域和糖尿病治疗满意度问卷评分有所改善。
结论
在血糖控制不佳的 1 型糖尿病患者中，传感器增强型泵治疗可有效降低 HbA1c。
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