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持续血糖监测可显著改善青少年1型糖尿病的血糖控制
作者:小柯机器人 发布时间:2020/6/17 22:32:33

美国佛罗里达Jaeb健康研究中心Kellee M. Miller联合哈佛医学院Lori M. Laffel团队探讨了持续血糖监测对青少年1型糖尿病血糖控制的影响。该成果发表在2020年6月16日出版的《美国医学会杂志》上。

在全年龄人群中,患有1型糖尿病的青少年血糖控制最差。连续血糖监测(CGM)已显示可改善成年人的血糖控制,但其对青少年是否有益尚不明确。

为了确定CGM对1型糖尿病青少年血糖控制的影响,2018年1月至2019年5月,研究组在美国的14项内分泌实践中进行了一项随机临床试验,招募了153位年龄为14-24岁的1型糖尿病患者,经筛查血红蛋白A1c(HbA1c)为7.5%-10.9%。将其按1:1随机分组,其中74例接受CGM,79例使用血糖仪进行常规血糖监测(BGM组)。

153名参与者的中位年龄为17岁,50%为女性,中位糖尿病持续时间为9年,其中142名(93%)患者完成了研究。在CGM组中,68%的参与者每周至少有5天使用CGM,持续6个月。CGM组的平均HbA1c在基线时为8.9%,在26周时为8.5%,而BGM组在基线和26周时均为8.9%,组间差异显著。

在20项预先指定的次要结局中,两组间7项二元HbA1c结果中的3项,9项CGM指标中的8项,以及患者报告的4项结果中的1项在统计学上存在显著差异。两组中最常报告的不良事件是严重的低血糖症(CGM组中有3名,BGM组中有2名)、高血糖/酮症(CGM组中有1名,BGM组中有4名)和糖尿病性酮症酸中毒(CGM组中有3名,BGM组中有1名)。

总之,对于患有1型糖尿病的青少年,连续血糖监测在26周内血糖控制改善幅度显著优于标准血糖监测。

附:英文原文

Title: Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial

Author: Lori M. Laffel, Lauren G. Kanapka, Roy W. Beck, Katherine Bergamo, Mark A. Clements, Amy Criego, Daniel J. DeSalvo, Robin Goland, Korey Hood, David Liljenquist, Laurel H. Messer, Roshanak Monzavi, Thomas J. Mouse, Priya Prahalad, Jennifer Sherr, Jill H. Simmons, R. Paul Wadwa, Ruth S. Weinstock, Steven M. Willi, Kellee M. Miller

Issue&Volume: 2020/06/16

Abstract: Importance  Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.

Objective  To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.

Design, Setting, and Participants  Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%.

Interventions  Participants were randomized 1:1 to undergo CGM (CGM group; n=74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n=79).

Main Outcomes and Measures  The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate.

Results  Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, 0.37% [95% CI, 0.66% to 0.08%]; P=.01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group).

Conclusions and Relevance  Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings.

DOI: 10.1001/jama.2020.6940

Source: https://jamanetwork.com/journals/jama/article-abstract/2767160

期刊信息

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
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex