1924-LB: 新型 CGM 系统的临床表现

IF 6.2 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes Pub Date : 2024-07-19 DOI:10.2337/db24-1924-lb
JULIA K. MADER, GUIDO FRECKMANN, THOMAS FORST, GERHARD VOGT, MICHAEL ANGSTMANN, SANDRA MOCERI, DANIEL MILITZ
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Participants wore 3 sensors at the back of the upper arms for 14 days and CGM data was compared with capillary glucose measurements (Accu-Chek® Guide) in in-clinic sessions throughout the wear time of the device. The study included glucose manipulations into hypo- and hyperglycemic ranges and the 20/20 agreement rate (percentage of values within ±20 mg/dL (< 100 mg/dL) as well as ±20% (≥ 100 mg/dL)) was evaluated as primary endpoint. In addition, secondary endpoints included the evaluation of the mean absolute relative difference (MARD) e.g. overall, for different time points and for dynamic (absolute rate-of-change ≥1 mg/dL/min) and stable glucose phases as well as safety endpoints. Results: In total, 48 participants (20 females, 28 males; 40 type 1, 8 type 2) were included into the study. The 20/20 agreement rate was 90.5 % (CI: 0.90 - 0.91). The overall MARD was 9.2 % over the entire run-time, 8.3 % for the beginning, 9.0 % for the middle and 10.8 % for the end of the wearing time as well as 8.8 % and 10.6 % for stable and dynamic glucose periods. No serious adverse events were reported during the study. A total of 15 device-related adverse events were reported, all due to application site reactions. Conclusion: In this study, the Accu-Chek® SmartGuide device has been proven to be safe and demonstrated a robust accuracy over a 14-day wear period including glucose manipulations. Disclosure J.K. Mader: Advisory Panel; Becton, Dickinson and Company. Speaker's Bureau; Becton, Dickinson and Company, A. Menarini Diagnostics, Boehringer-Ingelheim, diaTribe. Other Relationship; Diabetes UK. Stock/Shareholder; decide Clinical Software GmbH. Advisory Panel; embecta. Speaker's Bureau; embecta, Viatris Inc., Eli Lilly and Company. Advisory Panel; Eli Lilly and Company, Medtronic. Speaker's Bureau; Medtrust. Advisory Panel; Novo Nordisk A/S. Speaker's Bureau; Novo Nordisk A/S. Advisory Panel; PharmaSens, Roche Diabetes Care. Speaker's Bureau; Roche Diabetes Care. Board Member; Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Sanofi-Aventis Deutschland GmbH, Sanofi, Dexcom, Inc., Viatris Inc. Advisory Panel; Viatris Inc. Speaker's Bureau; Ypsomed AG. Research Support; European Union. Stock/Shareholder; elyte Diagnostics GmbH. Other Relationship; elyte Diagnostics GmbH. Board Member; European Association for the Study of Diabetes. Research Support; European Union Aviation Safety Agency. G. Freckmann: Advisory Panel; Abbott. Research Support; Ascensia Diabetes Care. Advisory Panel; Boydsense, Dexcom, Inc., Lilly Diabetes. Speaker's Bureau; Novo Nordisk. Advisory Panel; Perfood, PharmaSens. Consultant; Roche Diabetes Care. Research Support; Roche Diabetes Care. Consultant; Sinocare. Speaker's Bureau; Terumo Corporation. Consultant; Ypsomed AG. T. Forst: Speaker's Bureau; AstraZeneca, Daiichi Sankyo. Research Support; Johnson & Johnson Medical Devices Companies. Speaker's Bureau; Lilly Diabetes, Novo Nordisk. G. Vogt: Employee; Roche Diabetes Care. M. Angstmann: Employee; Roche Diabetes Care. S. Moceri: Employee; Roche Diabetes Care. D. Militz: Employee; Roche Diabetes Care.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":null,"pages":null},"PeriodicalIF":6.2000,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"1924-LB: Clinical Performance of a Novel CGM System\",\"authors\":\"JULIA K. MADER, GUIDO FRECKMANN, THOMAS FORST, GERHARD VOGT, MICHAEL ANGSTMANN, SANDRA MOCERI, DANIEL MILITZ\",\"doi\":\"10.2337/db24-1924-lb\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction and Objective: The use of continuous glucose monitoring (CGM) improves glycemic control in people with diabetes (PwD). 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Mader: Advisory Panel; Becton, Dickinson and Company. Speaker's Bureau; Becton, Dickinson and Company, A. Menarini Diagnostics, Boehringer-Ingelheim, diaTribe. Other Relationship; Diabetes UK. Stock/Shareholder; decide Clinical Software GmbH. Advisory Panel; embecta. Speaker's Bureau; embecta, Viatris Inc., Eli Lilly and Company. Advisory Panel; Eli Lilly and Company, Medtronic. Speaker's Bureau; Medtrust. Advisory Panel; Novo Nordisk A/S. Speaker's Bureau; Novo Nordisk A/S. Advisory Panel; PharmaSens, Roche Diabetes Care. Speaker's Bureau; Roche Diabetes Care. Board Member; Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Sanofi-Aventis Deutschland GmbH, Sanofi, Dexcom, Inc., Viatris Inc. Advisory Panel; Viatris Inc. Speaker's Bureau; Ypsomed AG. Research Support; European Union. Stock/Shareholder; elyte Diagnostics GmbH. Other Relationship; elyte Diagnostics GmbH. Board Member; European Association for the Study of Diabetes. Research Support; European Union Aviation Safety Agency. 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引用次数: 0

摘要

导言和目的:使用连续血糖监测(CGM)可改善糖尿病患者(PwD)的血糖控制。多种高精确度系统的出现使糖尿病患者及其医护人员能够根据各自的需求选择最适合每个人的方案。本研究旨在评估新型 CGM 系统 Accu-Chek® SmartGuide 设备在接受胰岛素治疗的糖尿病患者中的临床表现。研究方法进行了一项开放标签、单臂、前瞻性、非随机、多中心临床研究,以评估 Accu-Chek® SmartGuide 设备在年龄≥18 岁、接受胰岛素治疗的 1 型或 2 型糖尿病成人中的性能。参与者在上臂后部佩戴 3 个传感器 14 天,在整个设备佩戴期间,将 CGM 数据与门诊中的毛细血管葡萄糖测量值(Accu-Chek® Guide)进行比较。研究包括在低血糖和高血糖范围内的血糖操作,20/20 一致率(±20 mg/dL (< 100 mg/dL) 和 ±20% (≥ 100 mg/dL))作为主要终点进行评估。此外,次要终点还包括评估平均绝对相对差值(MARD),如总体、不同时间点、动态(绝对变化率≥1 mg/dL/min)和稳定血糖阶段以及安全性终点。结果共有 48 名参与者(女性 20 人,男性 28 人;1 型 40 人,2 型 8 人)参加了研究。20/20一致率为90.5%(CI:0.90 - 0.91)。整个运行时间的总体误差率为 9.2%,佩戴开始时为 8.3%,佩戴中期为 9.0%,佩戴结束时为 10.8%,血糖稳定期和动态血糖期的误差率分别为 8.8%和 10.6%。研究期间未报告严重不良事件。共报告了 15 起与设备相关的不良事件,均为佩戴部位反应。结论在这项研究中,Accu-Chek® SmartGuide 设备已被证明是安全的,并在 14 天的佩戴期(包括血糖操作)内表现出很高的准确性。披露 J.K. Mader:顾问团;Becton, Dickinson and Company。Speaker's Bureau; Becton, Dickinson and Company, A. Menarini Diagnostics, Boehringer-Ingelheim, diaTribe.其他关系;英国糖尿病协会。股票/股东;Decide Clinical Software GmbH。顾问团;embecta。Speaker's Bureau;embecta、Viatris Inc.、礼来公司。顾问团;礼来公司、美敦力。Speaker's Bureau; Medtrust.顾问团;Novo Nordisk A/S。发言人办公室;诺和诺德公司(Novo Nordisk A/S)。顾问团;PharmaSens、罗氏糖尿病护理公司。罗氏糖尿病护理公司发言人。赛诺菲-安万特德国有限公司董事会成员。赛诺菲-安万特德国有限公司、赛诺菲、Dexcom、Viatris Inc.演讲团成员。顾问团;Viatris Inc.Speaker's Bureau; Ypsomed AG.研究支持;欧盟。股票/股东;elyte Diagnostics GmbH。其他关系;elyte Diagnostics GmbH。董事会成员;欧洲糖尿病研究协会。研究支持;欧盟航空安全局。G. Freckmann:顾问团成员;雅培。研究支持;Ascensia Diabetes Care。顾问团;Boydsense、Dexcom 公司、礼来糖尿病公司。Speaker's Bureau; Novo Nordisk.顾问团;Perfood、PharmaSens。顾问;罗氏糖尿病护理公司。罗氏糖尿病护理公司研究支持。顾问;Sinocare。演讲人办公室;Terumo Corporation。Ypsomed AG 顾问。T. Forst:Speaker's Bureau; AstraZeneca, Daiichi Sankyo.研究支持;强生医疗器械公司。Speaker's Bureau; Lilly Diabetes, Novo Nordisk.G. Vogt:罗氏糖尿病护理公司员工。M. Angstmann:罗氏糖尿病护理公司员工。S. Moceri:罗氏糖尿病护理公司员工。D. Militz:罗氏糖尿病护理部员工。
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1924-LB: Clinical Performance of a Novel CGM System
Introduction and Objective: The use of continuous glucose monitoring (CGM) improves glycemic control in people with diabetes (PwD). The availability of multiple systems with high accuracy allows PwD and their health care professionals to choose the best option for each individual based on respective needs. This study aimed to evaluate the clinical performance of a novel CGM system, the Accu-Chek® SmartGuide device, in PwD on insulin therapy. Methods: An open label, single-arm, prospective, non-randomized, multi-center clinical study was performed to evaluate the performance of the Accu-Chek® SmartGuide device in adults aged ≥18 years with type 1 or type 2 diabetes on insulin therapy. Participants wore 3 sensors at the back of the upper arms for 14 days and CGM data was compared with capillary glucose measurements (Accu-Chek® Guide) in in-clinic sessions throughout the wear time of the device. The study included glucose manipulations into hypo- and hyperglycemic ranges and the 20/20 agreement rate (percentage of values within ±20 mg/dL (< 100 mg/dL) as well as ±20% (≥ 100 mg/dL)) was evaluated as primary endpoint. In addition, secondary endpoints included the evaluation of the mean absolute relative difference (MARD) e.g. overall, for different time points and for dynamic (absolute rate-of-change ≥1 mg/dL/min) and stable glucose phases as well as safety endpoints. Results: In total, 48 participants (20 females, 28 males; 40 type 1, 8 type 2) were included into the study. The 20/20 agreement rate was 90.5 % (CI: 0.90 - 0.91). The overall MARD was 9.2 % over the entire run-time, 8.3 % for the beginning, 9.0 % for the middle and 10.8 % for the end of the wearing time as well as 8.8 % and 10.6 % for stable and dynamic glucose periods. No serious adverse events were reported during the study. A total of 15 device-related adverse events were reported, all due to application site reactions. Conclusion: In this study, the Accu-Chek® SmartGuide device has been proven to be safe and demonstrated a robust accuracy over a 14-day wear period including glucose manipulations. Disclosure J.K. Mader: Advisory Panel; Becton, Dickinson and Company. Speaker's Bureau; Becton, Dickinson and Company, A. Menarini Diagnostics, Boehringer-Ingelheim, diaTribe. Other Relationship; Diabetes UK. Stock/Shareholder; decide Clinical Software GmbH. Advisory Panel; embecta. Speaker's Bureau; embecta, Viatris Inc., Eli Lilly and Company. Advisory Panel; Eli Lilly and Company, Medtronic. Speaker's Bureau; Medtrust. Advisory Panel; Novo Nordisk A/S. Speaker's Bureau; Novo Nordisk A/S. Advisory Panel; PharmaSens, Roche Diabetes Care. Speaker's Bureau; Roche Diabetes Care. Board Member; Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Sanofi-Aventis Deutschland GmbH, Sanofi, Dexcom, Inc., Viatris Inc. Advisory Panel; Viatris Inc. Speaker's Bureau; Ypsomed AG. Research Support; European Union. Stock/Shareholder; elyte Diagnostics GmbH. Other Relationship; elyte Diagnostics GmbH. Board Member; European Association for the Study of Diabetes. Research Support; European Union Aviation Safety Agency. G. Freckmann: Advisory Panel; Abbott. Research Support; Ascensia Diabetes Care. Advisory Panel; Boydsense, Dexcom, Inc., Lilly Diabetes. Speaker's Bureau; Novo Nordisk. Advisory Panel; Perfood, PharmaSens. Consultant; Roche Diabetes Care. Research Support; Roche Diabetes Care. Consultant; Sinocare. Speaker's Bureau; Terumo Corporation. Consultant; Ypsomed AG. T. Forst: Speaker's Bureau; AstraZeneca, Daiichi Sankyo. Research Support; Johnson & Johnson Medical Devices Companies. Speaker's Bureau; Lilly Diabetes, Novo Nordisk. G. Vogt: Employee; Roche Diabetes Care. M. Angstmann: Employee; Roche Diabetes Care. S. Moceri: Employee; Roche Diabetes Care. D. Militz: Employee; Roche Diabetes Care.
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来源期刊
Diabetes
Diabetes 医学-内分泌学与代谢
CiteScore
12.50
自引率
2.60%
发文量
1968
审稿时长
1 months
期刊介绍: Diabetes is a scientific journal that publishes original research exploring the physiological and pathophysiological aspects of diabetes mellitus. We encourage submissions of manuscripts pertaining to laboratory, animal, or human research, covering a wide range of topics. Our primary focus is on investigative reports investigating various aspects such as the development and progression of diabetes, along with its associated complications. We also welcome studies delving into normal and pathological pancreatic islet function and intermediary metabolism, as well as exploring the mechanisms of drug and hormone action from a pharmacological perspective. Additionally, we encourage submissions that delve into the biochemical and molecular aspects of both normal and abnormal biological processes. However, it is important to note that we do not publish studies relating to diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes mellitus. Our aim is to provide a platform for research that contributes to advancing our understanding of the underlying mechanisms and processes of diabetes.
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