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三项欧洲回顾性真实世界图表审查研究,以确定动态血糖监测对2型糖尿病成人糖化血红蛋白(HbA1c)的有效性。

Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes.

作者信息

Kröger Jens, Fasching Peter, Hanaire Hélène

机构信息

Zentrum für Diabetologie Hamburg Bergedorf, Glindersweg 80 Haus E, 21029, Hamburg, Germany.

Wilhelminenspital der Stadt Wien, Vienna, Austria.

出版信息

Diabetes Ther. 2020 Jan;11(1):279-291. doi: 10.1007/s13300-019-00741-9. Epub 2019 Dec 12.

Abstract

INTRODUCTION

The impact of flash glucose monitoring technology on HbA1c in type 2 diabetes managed by basal bolus insulin is uncertain. Three parallel European retrospective non-interventional chart review studies collected data reported in medical records. Each country's study aim was to determine the effectiveness of the device on HbA1c when used by their population for 3-6 months as their standard of care for management of glycaemia in a real-world setting.

METHODS

Medical records were eligible for adult patients with type 2 diabetes, on a basal bolus insulin regimen for 1 year or more, device use for 3 months or more before the start of the study, an HbA1c concentration up to 3 months prior to starting device use (patients were using blood glucose monitoring for self-management) between 64 and 108 mmol/mol (8.0-12.0%) plus an HbA1c determination 3-6 months after commencing flash glucose monitoring use.

RESULTS

Records were analysed from 18 medical centres in Austria (n = 92), France (n = 88) and Germany (n = 183). Baseline HbA1c results, recorded up to 90 days before the start of device use, were comparable across the three countries and were reduced significantly by 9.6 ± 8.8 mmol/mol mean ± SD (Austria [0.9 ± 0.8%], p < 0.0001), 8.9 ± 12.5 mmol/mol (France [0.8% ± 1.1], p < 0.0001) and 10.1 ± 12.2 mmol/mol (Germany [0.9% ± 1.1], p < 0.0001). No significant differences were detected between age group, sex, BMI or duration of insulin use.

CONCLUSIONS

Three European real-world, chart review studies in people with type 2 diabetes managed using basal bolus insulin therapy each concluded that HbA1c was significantly reduced after changing to use of flash glucose monitoring for 3-6 months in a real-world setting.

摘要

引言

在基础-餐时胰岛素治疗的2型糖尿病患者中,动态血糖监测技术对糖化血红蛋白(HbA1c)的影响尚不确定。三项平行的欧洲回顾性非干预性病历审查研究收集了病历中报告的数据。每个国家的研究目的是确定该设备在其人群中作为现实环境中血糖管理的标准治疗方法使用3至6个月时对HbA1c的有效性。

方法

符合条件的病历来自成年2型糖尿病患者,接受基础-餐时胰岛素治疗1年或更长时间,在研究开始前使用该设备3个月或更长时间,在开始使用设备前3个月内的HbA1c浓度(患者使用血糖监测进行自我管理)在64至108 mmol/mol(8.0-12.0%)之间,外加开始使用动态血糖监测3至6个月后的HbA1c测定值。

结果

分析了来自奥地利18个医疗中心(n = 92)、法国(n = 88)和德国(n = 183)的病历。在开始使用设备前90天内记录的基线HbA1c结果在三个国家之间具有可比性,并且平均显著降低了9.6±8.8 mmol/mol(标准差)(奥地利[0.9±0.8%],p < 0.0001)、8.9±12.5 mmol/mol(法国[0.8%±1.1],p < 0.0001)和10.1±12.2 mmol/mol(德国[0.9%±1.1],p < 0.0001)。在年龄组、性别、体重指数或胰岛素使用时长方面未检测到显著差异。

结论

三项针对使用基础-餐时胰岛素治疗的2型糖尿病患者的欧洲现实世界病历审查研究均得出结论,在现实环境中改用动态血糖监测3至6个月后,HbA1c显著降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c04c/6965548/13d89467f2fe/13300_2019_741_Fig1_HTML.jpg

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