JDRF randomized clinical trial to assess the efficacy of real-time continuous glucose monitoring in the management of type 1 diabetes: Research design and methods
JDRF randomized clinical trial to assess the efficacy of real-time continuous glucose monitoring in the management of type 1 diabetes: Research design and methods
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DOI：
10.1089/dia.2007.0302
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发表时间：
2008-08-01
影响因子：
5.4
通讯作者：
Tamborlane, William V.
中科院分区：
文献类型：
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作者：
Tamborlane, William V.
背景：虽然实时 (RT) 连续血糖监测 (CGM) 系统可能会彻底改变 I 型糖尿病 (T1D) 的治疗，但目前没有足够的证据支持这些设备的广泛使用。青少年糖尿病研究基金会 (JDRF) CGM 研究小组开展了一项随机临床试验，以确定 RT-CGM 是否可以改善 1 型糖尿病儿童和成人的血糖控制和生活质量。本文介绍了本研究中采用的研究设计和方法。方法：JDRF CGM 研究组试验是一项随机、平行组的有效性和安全性研究。符合资格标准的 T1DM 受试者被随机分配到单独进行标准血糖自我监测 (SMBG) 或使用当前三种 RT-CGM 系统中的任何一种作为 SMBG 的补充。 6 个月的随机期后，对照组接受 RT-CGM，两组均继续研究 6 个月。受试者分为两个队列：主要研究队列包括基线糖化血红蛋白 (HbA1c) 7.0-10.0%（含）的受试者，探索性试点研究队列包括 HbA1c < 7.0% 的受试者。 HbA1c 的差异是主要研究的主要结果。其他结果包括传感器葡萄糖值在 70-180 mg/dL 范围内的百分比、评估 RT-CGM 对 1 型糖尿病患者影响的问卷得分，以及 RT-CGM 的成本效益。结果：该研究的招募于 2007 年 12 月 15 日完成。结论：该临床试验的结果应有助于确定当前的 RT-CGM 设备是否对 1 型糖尿病患者有益。
Background: While real-time (RT) continuous glucose monitoring (CGM) systems may revolutionize treatment of type I diabetes (T1D), there is insufficient evidence currently available to support widespread utilization of these devices. The juvenile Diabetes Research Foundation (JDRF) CGM Study Group developed a randomized clinical trial to determine if RT-CGM can improve glycemic control and quality of life in children and adults with T1D. This paper presents the research design and methods that are being employed in this study.Methods: The JDRF CGM Study Group trial is a randomized, parallel group, efficacy and safety study. Subjects with T1DM who meet eligibility criteria are randomized to either standard self-monitoring of blood glucose (SMBG) alone or use of any of the three current RT-CGM systems as a supplement to SMBG. After the 6-month randomized period, the Control Group is offered use of RT-CGM, and both groups are studied for an additional 6 months. Subjects are divided into two cohorts: the Main Study Cohort includes subjects with baseline glycosylated hemoglobin (HbA1c) 7.0-10.0% inclusive, and the Exploratory Pilot Study Cohort includes subjects with HbA1c < 7.0%. Difference in HbA1c is the primary outcome in the Main Study. Other outcomes include the percentage of sensor glucose values within the 70-180 mg/dL range, scores on questionnaires that assess the impact of RT-CGM on living with T1D, and the cost-effectiveness of RT-CGM.Results: Recruitment for the study was completed on December 15, 2007.Conclusion: Results of this clinical trial should help establish whether or not current RT-CGM devices are beneficial to patients with T1D.