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Real-World Evidence to Reinforce Clinical Trial Evidence in Health Technology Assessment: A Critical Review of Real-World Evidence Requirements from Seven Countries and Recommendations to Improve Acceptance.加强卫生技术评估中临床试验证据的真实世界证据:对七个国家真实世界证据要求的批判性综述及提高接受度的建议
J Mark Access Health Policy. 2024 May 20;12(2):105-117. doi: 10.3390/jmahp12020009. eCollection 2024 Jun.
2
Limitations of 14-Day Continuous Glucose Monitoring Sampling for Assessment of Hypoglycemia and Glycemic Variability in Type 1 Diabetes.14 天连续血糖监测采样评估 1 型糖尿病患者低血糖和血糖变异性的局限性。
Diabetes Technol Ther. 2024 Jul;26(7):503-508. doi: 10.1089/dia.2023.0476. Epub 2024 Feb 16.
3
Comparing the glycaemic outcomes between real-time continuous glucose monitoring (rt-CGM) and intermittently scanned continuous glucose monitoring (isCGM) among adults and children with type 1 diabetes: A systematic review and meta-analysis of randomized controlled trials.比较实时连续血糖监测(rt-CGM)和间歇性扫描连续血糖监测(isCGM)在成人和儿童 1 型糖尿病患者中的血糖控制效果:一项随机对照试验的系统评价和荟萃分析。
Diabet Med. 2024 Mar;41(3):e15280. doi: 10.1111/dme.15280. Epub 2024 Jan 10.
4
7. Diabetes Technology: Standards of Care in Diabetes-2024.7. 糖尿病技术:2024年糖尿病护理标准
Diabetes Care. 2024 Jan 1;47(Suppl 1):S126-S144. doi: 10.2337/dc24-S007.
5
Minimum Sampling Duration for Continuous Glucose Monitoring Metrics to Achieve Representative Glycemic Outcomes in Suboptimal Continuous Glucose Monitor Use.在连续血糖监测设备使用欠佳的情况下,连续血糖监测指标达到具有代表性的血糖结果所需的最短采样持续时间。
J Diabetes Sci Technol. 2025 Mar;19(2):345-351. doi: 10.1177/19322968231200901. Epub 2023 Sep 25.
6
Continuous Glucose Monitoring Use in Older Adults for Optimal Diabetes Management.老年人连续血糖监测在优化糖尿病管理中的应用。
Diabetes Technol Ther. 2023 Jun;25(S3):S56-S64. doi: 10.1089/dia.2023.0111.
7
Continuous glucose monitoring and metrics for clinical trials: an international consensus statement.连续血糖监测及其临床试验指标:国际共识声明。
Lancet Diabetes Endocrinol. 2023 Jan;11(1):42-57. doi: 10.1016/S2213-8587(22)00319-9. Epub 2022 Dec 6.
8
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Diabetes Technol Ther. 2023 Feb;25(2):140-142. doi: 10.1089/dia.2022.0401. Epub 2022 Dec 2.
9
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J Diabetes Sci Technol. 2023 Sep;17(5):1226-1242. doi: 10.1177/19322968221085273. Epub 2022 Mar 29.
10
Continuous Glucose Monitoring Initiation Within First Year of Type 1 Diabetes Diagnosis Is Associated With Improved Glycemic Outcomes: 7-Year Follow-Up Study.1 型糖尿病诊断后一年内开始进行连续血糖监测与改善血糖结局相关:7 年随访研究。
Diabetes Care. 2022 Mar 1;45(3):750-753. doi: 10.2337/dc21-2004.

不同指标的不同时间:预测1型糖尿病患者每日多次注射治疗期间间歇性扫描持续葡萄糖监测数据的90天情况。一项多中心真实世界研究的结果

Different Times for Different Metrics: Predicting 90 Days of Intermittently Scanned Continuous Glucose Monitoring Data in Subjects With Type 1 Diabetes on Multiple Daily Injection Therapy. Findings From a Multicentric Real-World Study.

作者信息

Csermely Alessandro, Borella Nicolò D, Turazzini Anna, Pilati Martina, Sheiban Sara S, Bonadonna Riccardo C, Trevisan Roberto, Trombetta Maddalena, Lepore Giuseppe

机构信息

Division of Endocrinology, Diabetes and Metabolic Diseases, Department of Medicine, University Hospital of Verona, Verona, Italy.

Department of Medicine and Surgery, University of Parma, Parma, Italy.

出版信息

J Diabetes Sci Technol. 2025 Jan 7:19322968241308564. doi: 10.1177/19322968241308564.

DOI:10.1177/19322968241308564
PMID:39764582
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11705298/
Abstract

AIMS

According to the 2023 International Consensus, glucose metrics derived from two-week-long continuous glucose monitoring (CGM) can be extrapolated up to 90 days before. However, no studies have focused on adults with type 1 diabetes (T1D) on multiple daily injections (MDIs) and with second-generation intermittently scanned CGM (isCGM) sensors in a real-world setting.

METHODS

This real-world, retrospective study included 539 90-day isCGM data from 367 adults with T1D on MDI therapy. For each sensor metric, the coefficients of determination () were computed for sampling periods from 2 to 12 weeks versus the whole 90-day interval. Correlations were considered strong for ≥0.88.

RESULTS

The two-week sampling period displayed strong correlations for time in range (TIR, 70-180 mg/dl; = 0.89) and above range (TAR, >180 mg/dl; = 0.88). The four-week sampling period showed additional strong correlations for time in tight range (TITR, 70-140 mg/dl; = 0.92), for the coefficient of variation (CV; = 0.88), and for the glycemia risk index (GRI; = 0.92). The six-week sampling period displayed an additional strong correlation for time below range (TBR, <70 mg/dl; = 0.90). After stratification by clinical variables, lower values were found for older age quartiles (>40 years), higher CV (>36%), lower sensor use (≤94%), and higher HbA1c (>7.5%).

CONCLUSION

In patients with T1D on MDI, two- to six-week intervals of isCGM use can provide clinically useful estimates of TIR, TAR, TITR, TBR, CV, and GRI, which can be extrapolated to longer (up to 90 days) time intervals. Longer intervals might be needed in case of older age, higher glucose variability, lower sensor use, and higher HbA1c.

摘要

目的

根据2023年国际共识,源自为期两周的连续血糖监测(CGM)的血糖指标可以外推至此前90天。然而,尚无研究聚焦于在现实环境中接受多次皮下注射(MDI)治疗的1型糖尿病(T1D)成年患者以及使用第二代间歇性扫描CGM(isCGM)传感器的情况。

方法

这项现实世界的回顾性研究纳入了367例接受MDI治疗的T1D成年患者的539份为期90天的isCGM数据。对于每个传感器指标,计算了2至12周采样期与整个90天间隔期的决定系数()。当≥0.88时,相关性被认为很强。

结果

两周采样期在血糖达标时间(TIR,70 - 180 mg/dl; = 0.89)和血糖高于目标范围时间(TAR,>180 mg/dl; = 0.88)方面显示出很强的相关性。四周采样期在严格血糖达标时间(TITR,70 - 140 mg/dl; = 0.92)、变异系数(CV; = 0.88)和血糖风险指数(GRI; = 0.92)方面还显示出很强的相关性。六周采样期在血糖低于目标范围时间(TBR,<70 mg/dl; = 0.90)方面还显示出很强的相关性。按临床变量分层后,在年龄较大的四分位数组(>40岁)、较高的CV(>36%)、较低的传感器使用率(≤94%)和较高的糖化血红蛋白(HbA1c,>7.5%)中发现了较低的 值。

结论

在接受MDI治疗的T1D患者中,使用isCGM的2至6周间隔期可以提供TIR、TAR、TITR、TBR、CV和GRI的临床有用估计值,这些值可以外推至更长(长达90天)的时间间隔。在年龄较大、血糖变异性较高、传感器使用率较低和HbA1c较高的情况下,可能需要更长的间隔期。