Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections The GOLD Randomized Clinical Trial
Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections The GOLD Randomized Clinical Trial
复制标题
DOI：
10.1001/jama.2016.19976
复制
发表时间：
2017-01-24
影响因子：
120.7
通讯作者：
Hellman, Jarl
中科院分区：
文献类型：
--
作者：
Lind, Marcus;Polonsky, William;Hellman, Jarl
重要性大多数1型糖尿病患者都没有达到推荐的血糖目标。目的评估动态血糖监测对每日多次注射胰岛素治疗的1型糖尿病成人的影响。设计、环境和参与者开放标签交叉随机临床试验在瑞典15个糖尿病门诊进行2014年2月24日至6月1日2016年纳入了161名1型糖尿病患者，血红蛋白A（1c）（HbA（1c））至少为7.5%干预参与者被随机接受使用连续葡萄糖监测系统的治疗或常规治疗26周，主要结果和测量两种治疗在第26周和第69周之间HbA（1c）的差异。结果在161名随机参与者中，平均年龄为43.7岁，45.3%为女性，平均HbA（1c）为8.6%（70 mmol/mol）。共有142名参与者在两个治疗期内获得了随访数据。动态血糖监测期间平均HbA（1c）为7.92%（63 mmol/mol），常规治疗期间为8.35%（68 mmol/mol）（平均差异，-0.43% [95% CI，-0.57%至-0.29%]或-4.7 [-6.3至-3.1 mmol/mol]; P < .001）。在19个次要终点（包括心理社会和各种血糖测量）中，6个符合统计学显著性分层检验标准，与常规治疗相比，支持动态血糖监测。常规治疗组5例患者和动态血糖监测组1例患者发生重度低血糖。在冲洗时，患者使用常规治疗，7例有严重的低血糖症。结论和相关性在控制不充分的1型糖尿病患者治疗与每日多次胰岛素注射，使用动态血糖监测与常规治疗相比，26周导致较低的HbA（1C）。需要进一步的研究来评估临床结果和长期不良反应。
IMPORTANCE The majority of individuals with type 1 diabetes do not meet recommended glycemic targets.OBJECTIVE To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections.DESIGN, SETTING, AND PARTICIPANTS Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A(1c) (HbA(1c)) of at least 7.5%(58 mmol/mol) treated with multiple daily insulin injections.INTERVENTIONS Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks.MAIN OUTCOMES AND MEASURES Difference in HbA(1c) between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied.RESULTS Among 161 randomized participants, mean age was 43.7 years, 45.3% were women, and mean HbA(1c) was 8.6%(70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA(1c) was 7.92%(63 mmol/mol) during continuous glucose monitoring use and 8.35%(68 mmol/mol) during conventional treatment (mean difference, -0.43% [95% CI, -0.57% to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P < .001). Of 19 secondary end points comprising psychosocial and various glycemic measures, 6 met the hierarchical testing criteria of statistical significance, favoring continuous glucose monitoring compared with conventional treatment. Five patients in the conventional treatment group and 1 patient in the continuous glucose monitoring group had severe hypoglycemia. During washout when patients used conventional therapy, 7 patients had severe hypoglycemia.CONCLUSIONS AND RELEVANCE Among patients with inadequately controlled type 1 diabetes treated with multiple daily insulin injections, the use of continuous glucose monitoring compared with conventional treatment for 26 weeks resulted in lower HbA(1c). Further research is needed to assess clinical outcomes and longer-term adverse effects.