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本文引用的文献

1
Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor over Multiple Sensor Insertion and Removal Cycles.在多次传感器插入和移除周期中,植入式连续葡萄糖传感器的真实世界性能的纵向分析。
Diabetes Technol Ther. 2020 May;22(5):422-427. doi: 10.1089/dia.2019.0342.
2
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.1 型糖尿病闭环控制的 6 个月随机、多中心试验。
N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.
3
Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study.真实世界中多次使用植入式连续葡萄糖传感器的安全性:一项上市后注册研究。
Diabetes Technol Ther. 2020 Jan;22(1):48-52. doi: 10.1089/dia.2019.0159.
4
Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor.美国首例植入式连续血糖传感器商业使用者的真实世界数据。
Diabetes Technol Ther. 2019 Dec;21(12):677-681. doi: 10.1089/dia.2019.0234. Epub 2019 Aug 28.
5
Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range.临床连续血糖监测数据解读目标:时间范围国际共识推荐意见。
Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
6
Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable Continuous Glucose Monitoring System.关于 Eversense,首个长期植入式连续血糖监测系统常规使用的临床实践推荐
Diabetes Technol Ther. 2019 May;21(5):254-264. doi: 10.1089/dia.2018.0397. Epub 2019 Apr 25.
7
A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study.一项植入式连续血糖传感器准确性和安全性的前瞻性多中心评估:PRECISION 研究。
Diabetes Technol Ther. 2019 May;21(5):231-237. doi: 10.1089/dia.2019.0020. Epub 2019 Mar 29.
8
The Relationships Between Time in Range, Hyperglycemia Metrics, and HbA1c.血糖达标时间、高血糖指标与糖化血红蛋白之间的关系。
J Diabetes Sci Technol. 2019 Jul;13(4):614-626. doi: 10.1177/1932296818822496. Epub 2019 Jan 13.
9
6. Glycemic Targets: .6. 血糖目标: 。
Diabetes Care. 2019 Jan;42(Suppl 1):S61-S70. doi: 10.2337/dc19-S006.
10
Adoption Barriers for Continuous Glucose Monitoring and Their Potential Reduction With a Fully Implanted System: Results From Patient Preference Surveys.持续葡萄糖监测的采用障碍及其通过完全植入式系统的潜在降低:患者偏好调查结果
Clin Diabetes. 2018 Jan;36(1):50-58. doi: 10.2337/cd17-0053.

180 天可植入葡萄糖传感器的临床应用改善了 1 型糖尿病患者的糖化血红蛋白和达标时间。

Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes.

机构信息

Department of Health Science, University Magna Graecia, Catanzaro, Italy.

Department of Clinical and Experimental Medicine, University Magna Graecia, Catanzaro, Italy.

出版信息

Diabetes Obes Metab. 2020 Jul;22(7):1056-1061. doi: 10.1111/dom.13993. Epub 2020 Feb 27.

DOI:10.1111/dom.13993
PMID:32037699
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7317779/
Abstract

AIMS

This real-world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180-day Eversense CGM System (Eversense) in patients with type 1 diabetes.

MATERIALS AND METHODS

This was a prospective, multicentre, observational study among adult participants aged ≥18 years with type 1 diabetes across seven diabetes-care centres in Italy who had Eversense inserted for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range [TIR (glucose 70-180 mg/dL)], time above range [TAR (glucose >180 mg/dL)], time below range [TBR (glucose <70 mg/dL)] and glycaemic variability were also assessed. Data were also analysed by previous CGM use and by mode of insulin delivery.

RESULTS

One-hundred patients were enrolled (mean age 36 ± 12 years, mean baseline HbA1c 7.4 ± 0.92% [57 ± 10 mmol/mol]). Fifty-six per cent of patients were users of the continuous subcutaneous insulin infusion pump and 45% were previous users of CGM. HbA1c significantly decreased in patients after 180 days of sensor wear (-0.43% ± 0.69%, 5 ± 8 mmol/mol, P < 0.0001). As expected, CGM-naïve patients achieved the greatest reduction in HbA1c (-0.74% ± 0.48%, 8 ± 5 mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear.

CONCLUSIONS

Real-world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156).

摘要

目的

本真实世界研究评估了在 1 型糖尿病患者中使用可植入 180 天 Eversense 连续血糖监测(CGM)系统(Eversense)后,糖化血红蛋白(HbA1c)和连续血糖监测(CGM)指标的变化。

材料和方法

这是一项在意大利 7 家糖尿病护理中心进行的前瞻性、多中心、观察性研究,纳入了年龄≥18 岁、首次植入 Eversense 的成年 1 型糖尿病患者。在基线和 180 天时测量 HbA1c。还评估了时间在范围内(TIR(血糖 70-180mg/dL))、时间在范围之上(TAR(血糖>180mg/dL))、时间在范围之下(TBR(血糖<70mg/dL))和血糖变异性的变化。还根据先前的 CGM 使用情况和胰岛素输送方式分析了数据。

结果

共纳入 100 例患者(平均年龄 36±12 岁,平均基线 HbA1c 7.4±0.92%[57±10mmol/mol])。56%的患者使用连续皮下胰岛素输注泵,45%的患者为 CGM 使用者。在 180 天传感器佩戴后,患者的 HbA1c 显著降低(-0.43%±0.69%,5±8mmol/mol,P<0.0001)。正如预期的那样,CGM 初治患者 HbA1c 降低最大(-0.74%±0.48%,8±5mmol/mol)。在 180 天传感器佩戴后,TIR 显著增加,TAR 和平均每日传感器血糖显著降低,而 TBR 无变化。

结论

在 180 天内,真实世界中使用 Eversense CGM 系统与 1 型糖尿病成人患者的 HbA1c 和 CGM 指标的显著改善相关。该研究在 clinicaltrials.gov(NCT04160156)上注册。