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《1 型糖尿病患者多次胰岛素皮下注射治疗中 CGM 与自我血糖监测期间 HbA1c 与低血糖时间相关性的随机临床试验(GOLD-4)》

The Association Between HbA and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4).

机构信息

Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden

Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.

出版信息

Diabetes Care. 2020 Sep;43(9):2017-2024. doi: 10.2337/dc19-2606. Epub 2020 Jul 8.

DOI:10.2337/dc19-2606
PMID:32641374
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7440892/
Abstract

OBJECTIVE

According to recent guidelines, individuals with type 1 diabetes should spend <4.0% of time per day with glucose levels <3.9 mmol/L (<70 mg/dL) and <1.0% per day with glucose levels <3.0 mmol/L (<54 mg/dL).

RESEARCH DESIGN AND METHODS

In the GOLD randomized crossover trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomized to continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated over 16 months. We estimated the association between time spent in hypoglycemia and various mean glucose and HbA levels.

RESULTS

Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA <7.5% (<58 mmol/mol) had <1.0% time spent in hypoglycemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycemia <3.9 mmol/L. During CGM, mean time spent in hypoglycemia for individuals with mean HbA 7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for <3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%, respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.

CONCLUSIONS

Reaching current targets for time in hypoglycemia while at the same time reaching HbA targets is challenging for patients with type 1 diabetes treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycemia than SMBG at a broad range of HbA levels and is crucial for patients with MDI treatment if they are to have a chance to approach hypoglycemia targets.

摘要

目的

根据最新指南,1 型糖尿病患者每天应将血糖 <3.9mmol/L(<70mg/dL)的时间控制在<4.0%,血糖 <3.0mmol/L(<54mg/dL)的时间控制在<1.0%。

研究设计和方法

在 GOLD 随机交叉试验中,161 例接受多次胰岛素注射(MDI)治疗的 1 型糖尿病患者被随机分配至连续血糖监测(CGM)或常规治疗(自我血糖监测,SMBG),并在 16 个月内进行评估。我们估计了低血糖时间与各种平均血糖和 HbA 水平之间的关系。

结果

在 CGM 和常规治疗期间,随着平均 HbA 和平均血糖水平的降低,低血糖时间(<3.9mmol/L 和 <3.0mmol/L)显著增加。在 CGM 期间,24 例(57.1%)HbA<7.5%(<58mmol/mol)的患者 <1.0%时间的血糖<3.0mmol/L,23 例(54.8%)<4.0%时间的血糖<3.9mmol/L。在 CGM 期间,估计平均 HbA 为 7.0%(52mmol/mol)的个体的平均低血糖时间为 5.4%<3.9mmol/L 和 1.5%<3.0mmol/L。SMBG 时的相应值分别为 9.2%和 3.5%。平均血糖水平为 8mmol/L 的个体在 SMBG 时与 CGM 相比,血糖<3.9mmol/L 的时间增加了 4.9%,血糖<3.0mmol/L 的时间增加了 2.8%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a98a/7440892/237dd6937ccd/dc192606f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a98a/7440892/7b37521a7676/dc192606f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a98a/7440892/237dd6937ccd/dc192606f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a98a/7440892/7b37521a7676/dc192606f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a98a/7440892/237dd6937ccd/dc192606f2.jpg

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