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Guardian Connect 与 FreeStyle Libre 系统的头对头比较,以及对 1 型糖尿病患者传感器可接受性的评估。

A head-to-head comparison between Guardian Connect and FreeStyle Libre systems and an evaluation of user acceptability of sensors in patients with type 1 diabetes.

机构信息

Diabetes Centre, Admiralty Medical Centre, Singapore, Singapore.

Department of Medicine, Division of Endocrinology, Khoo Teck Puat Hospital, Singapore, Singapore.

出版信息

Diabetes Metab Res Rev. 2022 Oct;38(7):e3560. doi: 10.1002/dmrr.3560. Epub 2022 Jul 5.

Abstract

AIMS

A user-calibrated real-time continuous glucose monitoring (rt-CGM) system is compared to a factory-calibrated flash glucose monitoring (FGM) system and assessed in terms of accuracy and acceptability in patients with type 1 diabetes (T1D).

METHODS

Ten participants with T1D were enroled from a specialist diabetes centre in Singapore and provided with the Guardian Connect with Enlite Sensor (Medtronic, Northridge, CA, USA) and first-generation Freestyle Libre System (Abbott Diabetes Care, Witney, UK), worn simultaneously. Participants had to check capillary blood glucose four times per day. At the end of week 1 and week 2, participants returned for data download and were given a user evaluation survey.

RESULTS

Accuracy evaluation between Guardian Connect and Freestyle Libre includes the overall mean absolute relative difference value (9.7 ± 11.0% vs. 17.5 ± 10.9%), Clarke Error Grid zones A + B (98.6% vs. 98.1%), sensitivity (78.9% vs. 63.4%), and specificity (93.4% vs. 81.0%). Notably, time below range (<3.9 mmol/L) was 10.5% for FGM versus 2% for rt-CGM. From the evaluation survey, 90% of participants perceived rt-CGM to be accurate versus 40% for FGM, although the majority found both devices to be easy to use, educational, and useful in improving glycaemic control. However, due to the cost of sensors, only 30% were keen to use either device for continuous monitoring.

CONCLUSIONS

Although rt-CGM was superior to FGM in terms of accuracy, the value of glucose trends in both devices is still useful in diabetes self-management. Patients and clinicians may consider either technology depending on their requirements.

摘要

目的

用户校准的实时连续血糖监测(rt-CGM)系统与工厂校准的闪光血糖监测(FGM)系统进行比较,并评估其在 1 型糖尿病(T1D)患者中的准确性和可接受性。

方法

10 名 T1D 患者从新加坡的一家专科糖尿病中心入组,并同时佩戴 Guardian Connect with Enlite Sensor(美敦力,北岭,CA,美国)和第一代 Freestyle Libre System(Abbott Diabetes Care,威特尼,英国)。参与者必须每天检查 4 次毛细血管血糖。在第 1 周和第 2 周结束时,参与者返回下载数据,并接受用户评估调查。

结果

Guardian Connect 与 Freestyle Libre 的准确性评估包括总体平均绝对相对差异值(9.7±11.0% vs. 17.5±10.9%)、Clarke 误差网格区 A+B(98.6% vs. 98.1%)、灵敏度(78.9% vs. 63.4%)和特异性(93.4% vs. 81.0%)。值得注意的是,FGM 的血糖低于目标范围(<3.9mmol/L)的时间为 10.5%,而 rt-CGM 为 2%。从评估调查中,90%的参与者认为 rt-CGM 是准确的,而 40%的参与者认为 FGM 是准确的,尽管大多数人认为两种设备都易于使用、具有教育意义,有助于改善血糖控制。然而,由于传感器的成本,只有 30%的人热衷于使用任何一种设备进行连续监测。

结论

尽管 rt-CGM 在准确性方面优于 FGM,但两种设备的血糖趋势值在糖尿病自我管理中仍然有用。患者和临床医生可能会根据自己的需求考虑使用这两种技术。

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