美国佛罗里达州Jaeb健康研究中心Kellee M. Miller联合AdventHealth转化研究所Richard E. Pratley团队,分析了持续血糖监测对1型糖尿病老年人低血糖症的影响。相关论文发表在2020年6月16日出版的《美国医学会杂志》上。
连续血糖监测(CGM)可实时评估血糖水平,可能有助于减少1型糖尿病老年人的低血糖症。
为了确定与标准血糖监测(BGM)相比,CGM在1型糖尿病老年人中是否可有效降低低血糖症,研究组在美国22项内分泌实践中进行了一项随机临床试验,招募了203名60岁以上的1型糖尿病患者,按1:1将其随机分组,其中CGM组103例,标准BGM组100例。主要结果为在6个月的随访中,CGM测量的传感血糖值低于70 mg/dL的时间百分比。
203名参与者的中位年龄为68岁,1型糖尿病平均病程为36年,女性占52%,53%的患者使用胰岛素泵,平均HbA1c为7.5%,83%的参与者在6个月内每周至少6天使用了CGM。在CGM组中,血糖水平低于70 mg/dL的时间百分比在基线时为5.1%(每天73分钟),在随访期间为2.7%(每天39分钟);标准BGM组则分别为4.7%(每天68分钟)和4.9%(每天70分钟),组间差异显著。
在31个预先指定的次要终点中,所有9个CGM指标、7个HbA1c结果中的6个在统计学上均存在显著差异,而15个认知和患者报告的结果则没有差异。与标准BGM组相比,CGM组的平均HbA1c显著降低。使用CGM和标准BGM报道的最常见不良事件包括严重的低血糖症(分别为1例和10例)、骨折(5例和1例)、跌倒(4例和3例)以及急诊就诊(6例和8例)。
总之,对于60岁以上的1型糖尿病患者,连续血糖监测与标准血糖监测相比,可显著改善6个月内的低血糖症。
附:英文原文
Title: Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial
Author: Richard E. Pratley, Lauren G. Kanapka, Michael R. Rickels, Andrew Ahmann, Grazia Aleppo, Roy Beck, Anuj Bhargava, Bruce W. Bode, Anders Carlson, Naomi S. Chaytor, D. Steven Fox, Robin Goland, Irl B. Hirsch, Davida Kruger, Yogish C. Kudva, Carol Levy, Janet B. McGill, Anne Peters, Louis Philipson, Athena Philis-Tsimikas, Rodica Pop-Busui, Viral N. Shah, Michael Thompson, Francesco Vendrame, Alandra Verdejo, Ruth S. Weinstock, Laura Young, Kellee M. Miller
Issue&Volume: 2020/06/16
Abstract: Importance Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes.
Objective To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes.
Design, Setting, and Participants Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes.
Interventions Participants were randomly assigned in a 1:1 ratio to use CGM (n=103) or standard BGM (n=100).
Main Outcomes and Measures The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate.
Results Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, 1.9% (27 minutes per day); 95% CI, 2.8% to 1.1% [40 to 16 minutes per day]; P<.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, 0.3%; 95% CI, 0.4% to 0.1%; P<.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8).
Conclusions and Relevance Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit.
DOI: 10.1001/jama.2020.6928
Source: https://jamanetwork.com/journals/jama/article-abstract/2767159
JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
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投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex