Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes
Background The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined.
been determined 定まっていない、明らかにされていない
Methods In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks.
In a multicenter clinical trial 多施設臨床試験において
randomly assigned A to B or to C AをBかCに無作為に割り付ける
were stratified into ～に階層化した、層別化した
primary outcome 主要転帰
Results The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, –0.53%; 95% confidence interval [CI], –0.71 to –0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, –0.17 to 0.33; P=0.52) or among those who were 8 to 14 years of age (mean difference, –0.13; 95% CI, –0.38 to 0.11; P=0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference.
with a significant difference among ～間では有意差をもって
between-group difference 群間の差、グループ間の差
この言い回しはおもしろいですね。通常なら difference between groupsとなるのでしょう。
Conclusions Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents.
Further work is needed さらなる研究が必要である
NEJMのサイトはThe New England Journal of Medecineで見られます。abstractは無料で閲覧できますから、どうぞ。