Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study.
Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study.
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DOI：
10.2337/dc09-0750
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发表时间：
2009-12
期刊：
影响因子：
16.2
通讯作者：
Nicolino M
中科院分区：
文献类型：
--
作者：
Raccah D;Sulmont V;Reznik Y;Guerci B;Renard E;Hanaire H;Jeandidier N;Nicolino M
比较使用持续血糖监测与标准血糖自我监测的患者中与转换为胰岛素泵治疗相关的血糖控制改善。RealTrend研究是一项为期6个月、随机、平行组、双臂、开放标签研究，纳入了132名接受每日多次注射治疗的未控制的1型糖尿病（A1 C ≥8%）成人和儿童。一组配备Medtronic MiniMed Paradigm REAL-Time系统（PRT组），这是一种具有集成连续皮下葡萄糖监测（CGM）功能的胰岛素泵，说明至少70%的时间佩戴CGM传感器。另一组（持续皮下胰岛素输注[CSII]组）开始常规胰岛素泵治疗。结果指标包括A1 C和血糖变异性。共有115名患者完成了研究。从基线到试验结束，两组的A1 C均显著改善（PRT组-0.81 ± 1.09%，P < 0.001; CSII组-0.57 ± 0.94%，P < 0.001），两组之间无显著差异。当考虑到91例完全依从方案的患者（包括CGM探头佩戴≥70%的时间）时，PRT组的A1 C改善显著更大（P = 0.004）（PRT组−0.96 ± 0.93%，P < 0.001; CSII组−0.55 ± 0.93%，P < 0.001）。高血糖参数降低与A1 C改善一致，对低血糖无影响。在至少70%的时间佩戴CGM传感器的患者中，在使用胰岛素泵的前6个月内，CGM胰岛素泵治疗比传统胰岛素泵治疗改善了10%以上。
To compare the improvements in glycemic control associated with transitioning to insulin pump therapy in patients using continuous glucose monitoring versus standard blood glucose self-monitoring. The RealTrend study was a 6-month, randomized, parallel-group, two-arm, open-label study of 132 adults and children with uncontrolled type 1 diabetes (A1C ≥8%) being treated with multiple daily injections. One group was fitted with the Medtronic MiniMed Paradigm REAL-Time system (PRT group), an insulin pump with integrated continuous subcutaneous glucose monitoring (CGM) capability, with instructions to wear CGM sensors at least 70% of the time. Conventional insulin pump therapy was initiated in the other group (continuous subcutaneous insulin infusion [CSII] group). Outcome measures included A1C and glycemic variability. A total of 115 patients completed the study. Between baseline and trial end, A1C improved significantly in both groups (PRT group −0.81 ± 1.09%, P < 0.001; CSII group −0.57 ± 0.94%, P < 0.001), with no significant difference between groups. When the 91 patients who were fully protocol-compliant (including CGM sensor wear ≥70% of the time) were considered, A1C improvement was significantly greater in the PRT group (P = 0.004) (PRT group −0.96 ± 0.93%, P < 0.001; CSII group −0.55 ± 0.93%, P < 0.001). Hyperglycemia parameters decreased in line with improvements in A1C with no impact on hypoglycemia. CGM-enabled insulin pump therapy improves glycemia more than conventional pump therapy during the first 6 months of pump use in patients who wear CGM sensors at least 70% of the time.
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影响因子：
7.7
作者：
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作者：
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作者：
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通讯作者：
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