持續血糖監測可顯著改善青少年1型糖尿病的血糖控制
作者:
小柯機器人發布時間:2020/6/17 22:32:33
美國佛羅裡達Jaeb健康研究中心Kellee M. Miller聯合哈佛醫學院Lori M. Laffel團隊探討了持續血糖監測對青少年1型糖尿病血糖控制的影響。該成果發表在2020年6月16日出版的《美國醫學會雜誌》上。
在全年齡人群中,患有1型糖尿病的青少年血糖控制最差。連續血糖監測(CGM)已顯示可改善成年人的血糖控制,但其對青少年是否有益尚不明確。
為了確定CGM對1型糖尿病青少年血糖控制的影響,2018年1月至2019年5月,研究組在美國的14項內分泌實踐中進行了一項隨機臨床試驗,招募了153位年齡為14-24歲的1型糖尿病患者,經篩查血紅蛋白A1c(HbA1c)為7.5%-10.9%。將其按1:1隨機分組,其中74例接受CGM,79例使用血糖儀進行常規血糖監測(BGM組)。
153名參與者的中位年齡為17歲,50%為女性,中位糖尿病持續時間為9年,其中142名(93%)患者完成了研究。在CGM組中,68%的參與者每周至少有5天使用CGM,持續6個月。CGM組的平均HbA1c在基線時為8.9%,在26周時為8.5%,而BGM組在基線和26周時均為8.9%,組間差異顯著。
在20項預先指定的次要結局中,兩組間7項二元HbA1c結果中的3項,9項CGM指標中的8項,以及患者報告的4項結果中的1項在統計學上存在顯著差異。兩組中最常報告的不良事件是嚴重的低血糖症(CGM組中有3名,BGM組中有2名)、高血糖/酮症(CGM組中有1名,BGM組中有4名)和糖尿病性酮症酸中毒(CGM組中有3名,BGM組中有1名)。
總之,對於患有1型糖尿病的青少年,連續血糖監測在26周內血糖控制改善幅度顯著優於標準血糖監測。
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