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2型糖尿病控制不佳患者中患者主导与医生主导的甘精胰岛素滴定:一项随机多国ATLAS研究

Patient-led versus physician-led titration of insulin glargine in patients with uncontrolled type 2 diabetes: a randomized multinational ATLAS study.

作者信息

Garg Satish K, Admane Karim, Freemantle Nick, Odawara Masato, Pan Chang-Yu, Misra Anoop, Jarek-Martynowa Iwona R, Abbas-Raza Syed, Mirasol Roberto C, Perfetti Riccardo

机构信息

Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, Colorado.

Global Diabetes Division, Sanofi, Paris, France.

出版信息

Endocr Pract. 2015 Feb;21(2):143-57. doi: 10.4158/EP14079.OR.

Abstract

OBJECTIVE

Self-adjustment of insulin dose is commonly practiced in Western patients with type 2 diabetes but is usually not performed in Asian patients. This multinational, 24-week, randomized study compared patient-led with physician-led titration of once-daily insulin glargine in Asian patients with uncontrolled type 2 diabetes who were on 2 oral glucose-lowering agents.

METHODS

Patient-led (n = 275) or physician-led (n = 277) subjects followed the same dose-titration algorithm guided by self-monitored fasting blood glucose (FBG; target, 110 mg/dL [6.1 mmol/L]). The primary endpoint was change in mean glycated hemoglobin (HbA1c) at week 24 in the patient-led versus physician-led titration groups.

RESULTS

Patient-led titration resulted in a significantly higher drop in HbA1c value at 24 weeks when compared with physician-led titration (-1.40% vs. -1.25%; mean difference, -0.15; 95% confidence interval, -0.29 to 0.00; P = .043). Mean decrease in FBG was greatest in the patient-led group (-2.85 mmol/L vs. -2.48 mmol/L; P = .001). The improvements in HbA1c and FBG were consistent across countries, with similar improvements in treatment satisfaction in both groups. Mean daily insulin dose was higher in the patient-led group (28.9 units vs. 22.2 units; P<.001). Target HbA1c of <7.0% without severe hypoglycemia was achieved in 40.0% and 32.9% in the patient-led and physician-led groups, respectively (P = .086). Severe hypoglycemia was not different in the 2 groups (0.7%), with an increase in nocturnal and symptomatic hypoglycemia in the patient-led arm.

CONCLUSION

Patient-led insulin glargine titration achieved near-target blood glucose levels in Asian patients with uncontrolled type 2 diabetes who were on 2 oral glucose-lowering drugs, demonstrating that Asian patients can self-uptitrate insulin dose effectively when guided.

摘要

目的

在西方2型糖尿病患者中,自行调整胰岛素剂量很常见,但在亚洲患者中通常不这样做。这项跨国、为期24周的随机研究比较了在接受两种口服降糖药治疗但血糖控制不佳的亚洲2型糖尿病患者中,由患者主导与由医生主导的甘精胰岛素每日一次滴定法。

方法

由患者主导(n = 275)或由医生主导(n = 277)的受试者遵循相同的剂量滴定算法,该算法由自我监测的空腹血糖(FBG;目标值为110 mg/dL [6.1 mmol/L])指导。主要终点是在第24周时,患者主导滴定组与医生主导滴定组糖化血红蛋白(HbA1c)均值的变化。

结果

与医生主导的滴定相比,患者主导的滴定在24周时HbA1c值下降幅度显著更大(-1.40% 对 -1.25%;平均差值为 -0.15;95% 置信区间为 -0.29至0.00;P = 0.043)。患者主导组的空腹血糖平均下降幅度最大(-2.85 mmol/L对 -2.48 mmol/L;P = 0.001)。各国HbA1c和FBG的改善情况一致,两组治疗满意度的改善情况相似。患者主导组的平均每日胰岛素剂量更高(28.9单位对22.2单位;P<0.001)。患者主导组和医生主导组分别有40.0%和32.9%的患者实现了目标HbA1c<7.0%且无严重低血糖(P = 0.086)。两组严重低血糖情况无差异(0.7%),患者主导组夜间和有症状低血糖有所增加。

结论

在接受两种口服降糖药治疗但血糖控制不佳的亚洲2型糖尿病患者中,患者主导的甘精胰岛素滴定实现了接近目标的血糖水平,表明亚洲患者在指导下能够有效自行增加胰岛素剂量。

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