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July 9, 2007 — 两项微侵袭性持续血糖监测（CBGM）装置比较发现，在协助接受胰岛素治疗病患达到长期血糖控制上，两种装置并无差异。
这项来自微创科技角色与评估（MITRE）研究的数据，发表在伊利诺州芝加哥美国糖尿病医学会第67届科学座谈会上。
英国伦敦大学tanton Newman哲学博士向Medscape表示，这些发现对我们来说是项惊喜，因为我们认为提供持续性血糖资讯将会协助且可以改善HBA1c。
研究者在一项收纳超过400位接受胰岛素治疗的第一型与第二型糖尿病病患的研究中，比较两项微创型CBGM装置；在这些研究中，102位被随机分派接受持续血糖监视系统（CGMS），由Minimed公司研发，而另外100位病患接受Biographer，由Animas公司制造；剩下的病患被分派到标准控制组、或是一“照顾”控制组，以控制因接受CBGM而增加与健康照护人员接触所带来的效应。
CGMS透过一条导线与皮下植入监测器相连，且可以穿戴长达72小时，每5分钟纪录一次血糖值；生物记录器附着于皮肤上，且透过电渗透性地抽取液体达12~15小时，每10分钟纪录一次。
这项研究的主要是试验终点为长期血糖控制，由18个月的糖化血红素（HBA1c）变化表示，收纳到这项研究的病患HBA1c自7.0~15.5%。
这四组病患的平均HBA1c值都是下降的，特别是在试验开始的前几个月；第18个月时，HBA1c值相对下降至少12.5%的病患，在生物记录器组为15%、在CGMS组为27%、在标准控制组为24%、在照顾控制组为27%；相较于试验前，HBA1c值相对下降了1~4.6%。
作者在摘要中表示，这些结果都与试验前、或是其他组别无显著差异；这些结果显示，使用CGMS会有少数好处，但是仅止于短期；除此之外，CGMS组这些短期的变化与他组比起来并不显著。
根据Newman医师表示，找出特定会因为使用CGMS系统而受益的族群，将是未来的研究重点；他表示，如果我们要了解这些装置的好处，更大型、更适当的研究设计将是基本的。
然而，临床糖尿病教授与英格兰Sheffield教学医院信托研究发展部门主任Simon Heller博士向Medscape表示，许多临床医师尚不知道如何使用这些仪器所记录到的讯息，因此，在这项设计良好的研究中，有这样的结果并不令人意外。
Heller博士附带表示，我们必须学习如何使用这些新科技，而且或许是藉由前驱研究来探索协助病患与医师得到这些数据的最佳方法；此时，这些装置应该作为研究工具，且不应直接贩卖给病患。
这项研究由国家健康研究机构（NIHR）健康科技评估计划赞助，这里所表达的看法与意见仅为作者个人，并不代表NIHR；作者之一的Steven J. Hurel博士为Lifescan公司的顾问团成员之一，该公司为OneTouch血糖监测计的制造厂商；Heller博士接受Menarini、罗氏药厂与Medtronic公司的演讲费。
Continuous Blood Glucose Monitoring Shows No Effect on Long-Term Glucose Control
By Emma Hitt, PhD
Medscape Medical News
July 9, 2007 — A comparison of 2 minimally invasive continuous blood glucose monitoring (CBGM) devices indicates that neither machine is significantly better than either controls or the other device in helping to achieve long-term glucose control in insulin-treated patients with diabetes mellitus.
The new findings, from the Minimally Invasive Technology Role and Evaluation (MITRE) study, were presented at the American Diabetes Association 67th Scientific Sessions, in Chicago, Illinois.
"These findings were surprising to us because we thought that providing continuous blood glucose information would be helpful and would lead to improvements in HbA1c," Stanton Newman, DPhil, from the University College London, England, told Medscape.
The researchers evaluated the efficacy of 2 minimally invasive CBGM devices in a study of more than 400 patients with type 1 or type 2 diabetes treated with insulin. Of the patients, 102 were randomly assigned to the Continuous Glucose Monitoring System (CGMS), manufactured by Minimed, and 100 patients were assigned to the Biographer, manufactured by Animas. The remaining patients were assigned to either a standard control group or an "attention" control group to control for the potential effect of increased contact with healthcare professionals in patients receiving CBGM.
The CGMS is connected via a wire to a subcutaneous sensor and can be worn for up to 72 hours, taking recordings every 5 minutes; the Biographer attaches to the skin and extracts fluid electro-osmotically for 12 to 15 hours, taking recordings every 10 minutes.
The primary endpoint was long-term glucose control, as indicated by changes in glycosylated hemoglobin (HbA1c) levels for 18 months. Patients entering into the study had a mean baseline HbA1c level ranging from 7.0% to 15.5%.
All 4 patient groups demonstrated a decline in mean HbA1c, especially during the first few months of the study. By month 18, the percentage of patients who had a relative reduction of at least 12.5% was 15% in the Biographer group, 27% in the CGMS group, 24% in the standard control, and 27% in the attention control group. The relative decline in HbA1c from baseline ranged from 1% to 4.6%.
None of these differences was significantly different from baseline or the results of the other groups. "These results suggest that the use of the CGMS conferred a small benefit, but only in the short term," the authors stated in their abstract. Furthermore, these short-term changes in the CGMS were not significant in comparison to the attention control group.
According to Dr. Newman, it is important to further establish whether specific subgroups of patients do show benefits with CBGM. "Future studies that are appropriately powered and designed are essential if we are going to understand the benefits or these devices or lack thereof," he noted.
However, Simon Heller, BA, MB BChir, DM, FRCP, professor of clinical diabetes and director of research and development with the Sheffield Teaching Hospitals Foundation Trust, in England, told Medscape that "many clinicians have not yet worked out how to use information generated by these devices, so it is to be expected that in this well-designed trial there would be no real effect.
"We need to learn more about how to use this new technology and, perhaps with pilot studies, explore the best way to help both patients and clinicians get the most out of the data generated," Dr. Heller added. "At the moment, these devices should be primarily used as research tools and should not be sold directly to patients."
The study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR. Steven J. Hurel, PHD, FRCP, one of the authors, sits on an advisory panel for Lifescan, manufacturer of OneTouch glucose meters. Dr. Heller has received speaker fees from Menarini, Roche, and Medtronic.
American Diabetes Association 67th Scientific Sessions: Abstract 0115-OR. Presented June 23, 2007.