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Accuracy and Safety of Anytime 5Pro and Anytime 4Pro CGM Systems in Adults With Diabetes

2026年6月8日 更新者：Yuwell Group

Accuracy and Safety Evaluation of the Anytime 5Pro and Anytime 4Pro Continuous Glucose Monitoring Systems in Adults With Diabetes: A Post-Market Clinical Follow-up Investigation

This post-market clinical follow-up (PMCF) investigation evaluates the accuracy and safety of two CE-marked continuous glucose monitoring (CGM) systems, the Anytime 5Pro and the Anytime 4Pro, in adults with type 1 or type 2 diabetes. Each participant simultaneously wears one Anytime 5Pro sensor and one Anytime 4Pro sensor, one on each upper arm, for the full labelled wear period of each device (up to 16 and 15 days, respectively). CGM readings are compared against venous blood glucose measured by a laboratory reference analyzer (YSI 2500) during four in-clinic sampling sessions that include controlled glucose manipulation. Participants are masked to real-time CGM readings throughout the study. The investigation is conducted to confirm device performance and safety under real-world conditions of use in a European population, in line with the manufacturer's post-market clinical follow-up obligations under the EU Medical Device Regulation.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a prospective, multi-centre, dual-device (paired intra-subject), objective performance criteria PMCF investigation. The investigation will be conducted at two clinical site(s) in Poland. Each participant will simultaneously wear two CGM sensors: one Anytime 5Pro sensor and one Anytime 4Pro sensor, each inserted on the posterior-lateral side of one upper arm (one sensor per arm), each for the duration of its respective labelled wear life. The Anytime 4Pro sensor will be worn from insertion on Day 1 until its removal at Visit 5 on Day 16, following completion of the Session 4 reference sampling and full data synchronisation (15-day labelled wear life). The Anytime 5Pro sensor will be worn from insertion on Day 1 until its removal at Visit 6 on Day 17 (16-day labelled wear life). During the study course participants will not be able to read the real-time CGM glucose readings; the mobile application display will be masked throughout the sensor wear period. Each participant will be provided with sponsor-supplied smartphone(s) with the Yuwell Anytime companion application installed. The smartphone will be carried by the participant throughout the sensor wear period to maintain continuous Bluetooth data transfer from the transmitter. The application display will be masked so that participants cannot view their glucose values, trends, or alerts.

Sensor placement side will be allocated deterministically at Visit 1 based on the participant identifier parity assigned at enrolment. Even-numbered participant identifier (Allocation A): Anytime 5Pro on the right upper arm, Anytime 4Pro on the left upper arm. Odd-numbered participant identifier (Allocation B): Anytime 5Pro on the left upper arm, Anytime 4Pro on the right upper arm. Because participant identifiers are issued sequentially, this rule yields a balanced 1:1 distribution of placement-side allocations across participants and across participating centres, without the need for envelope-based randomisation. The rationale for this deterministic allocation is to control for potential systematic side-related bias (dominant arm use, sleeping posture, adhesion wear) when comparing the two devices within-subject.

A total of 140 sensors will be used in the investigation: 70 Anytime 5Pro sensors and 70 Anytime 4Pro sensors (one of each per participant).

Each participant will attend a total of six clinic visits. Visit 1 (Day 1) is the screening, enrolment and dual sensor insertion visit, during which eligibility assessments will be performed, informed consent obtained, and one Anytime 5Pro sensor and one Anytime 4Pro sensor inserted on the contralateral upper arms in accordance with the deterministic side allocation rule. The Anytime 5Pro sensor will undergo a 45-minute warm-up and the Anytime 4Pro sensor a 60-minute warm-up. The participant will also receive the sponsor-supplied smartphone(s) with the Yuwell Anytime application installed in masked mode. The four subsequent in-clinic venous blood sampling sessions will be scheduled at different phases of the sensor wear period: Session 1 (Visit 2, Day 2) - Beginning; Session 2 (Visit 3, Day 6 or Day 7) - Early middle; Session 3 (Visit 4, Day 10 or Day 11) - Late middle; Session 4 (Visit 5, Day 16, to be started before 09:00) - End. Each session will last 9 hours, with venous blood sampled every 15+/-3 minutes to obtain paired CGM-reference measurements for accuracy assessment. As a pre-defined exception, for 2 participants (1 per site, scheduled in the mid-to-late stage of the investigation), Visit 1 and Visit 2 will be combined and their Session 1 will last 12 hours from sensor insertion, to capture the first 12 hours of wear (during which accuracy may vary per the IFU); participation in the combined visit is an optional element the participant marks in the main informed consent form. At Visit 5 (Day 16), following completion of Session 4 reference sampling and full Anytime 4Pro data synchronisation, the Anytime 4Pro sensor will be removed at the end of its 15-day labelled wear life and its insertion site assessed. Visit 6 (Day 17, after 19:00) will be the Anytime 5Pro sensor removal visit, during which the Anytime 5Pro sensor will be removed, post-removal skin assessment and the usability questionnaires will be performed, and adverse events will be reviewed. Between clinic visits, participants will wear both sensors in the home-use setting under their usual daily conditions. Because the application display is masked, participants will not receive glucose values, trends or alerts from the investigational devices; glucose management decisions during the study will therefore be based on standard-of-care methods (fingerstick blood glucose monitoring or the participant's usual CGM system, if applicable) and not on the investigational device readings.

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Diagnosis of type 1 or type 2 diabetes mellitus, documented in medical records, with diabetes established at least 6 months prior to Day 1.
  2. Age >= 18 years at the time of informed consent.
  3. Stable vital signs at screening (systolic blood pressure 90-180 mmHg, diastolic blood pressure 50-110 mmHg, heart rate 50-100 bpm, body temperature 35.5-37.5 C).
  4. Feasibility of establishing forearm venous access for repeated blood sampling.
  5. Haematocrit <= 70%.
  6. For T1D participants: prior experience with a CGM system (any brand).
  7. Willingness and ability to comply with the investigation procedures, including wearing both sensors (one Anytime 5Pro and one Anytime 4Pro) simultaneously throughout the 17-day participation period, attending six scheduled clinic visits, and participating in glucose manipulation procedures.
  8. Written informed consent obtained prior to any investigation-related procedures.

Exclusion Criteria:

  1. Skin disorders at the prospective sensor insertion site (posterior-lateral upper arm), including scarring, redness, swelling, infection, or tattoos.
  2. Known allergies to alcohol-based disinfectants or medical adhesives.
  3. Coagulation abnormalities or bleeding disorders, or current use of anticoagulant therapy (except low-dose aspirin).
  4. Current pregnancy, suspected pregnancy, or lactation.
  5. History of epilepsy or psychiatric disorders that may compromise investigation compliance or subject safety during glucose manipulation procedures.
  6. Severe hepatic or renal insufficiency.
  7. Current use of medications known to interfere with CGM readings, including ascorbic acid (vitamin C) supplementation >1000 mg/day.
  8. Concurrent participation in another interventional device or drug trial, or participation within the past 30 days.
  9. Known drug or alcohol abuse.
  10. Any condition that, in the judgement of the investigator, would make the subject unsuitable for participation in this investigation or would compromise the subject's safety.

  11. Planned magnetic resonance imaging (MRI), computed tomography (CT), X-ray examination, or diathermic therapy during the sensor wear period.

    -

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Dual CGM wear (Anytime 5Pro + Anytime 4Pro)
设备：Reference venous blood sampling (YSI 2500)
During the four in-clinic reference sampling sessions, participants undergo controlled manipulation of blood glucose to obtain paired CGM-reference measurements spanning a wide glucose range, including hypoglycaemic and hyperglycaemic levels. Glucose is raised and/or lowered under continuous medical supervision using standard clinical means (e.g., carbohydrate intake and/or insulin administration) according to the protocol, with predefined safety limits and stopping rules. Each session lasts up to 9 hours, with venous blood sampled every 15 (+/-3) minutes via an indwelling catheter for reference glucose measurement on the YSI 2500 analyzer. The purpose is to ensure adequate representation of low, mid-range, and high glucose values for the accuracy endpoints (MARD, agreement rates, and Consensus Error Grid analysis), rather than to treat the participant's diabetes.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean Absolute Relative Difference (MARD) between CGM and reference glucose
大体时间：Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)
MARD across the reportable glucose range (30-500 mg/dL), reported separately for each device. Calculated as the mean of the absolute values of (CGM value - reference value) / reference value, expressed as a percentage, across all evaluable paired CGM-reference points. Reported for the Anytime 5Pro and the Anytime 4Pro independently.
Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)
Agreement rate within +/-20%/+/-20 mg/dL of reference glucose
大体时间：Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)
Proportion of paired CGM-reference points within +/-20 mg/dL of the reference for reference values <=80 mg/dL, or within +/-20% of the reference for reference values >80 mg/dL, reported separately for the Anytime 5Pro and the Anytime 4Pro.
Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)
Proportion of paired points in Consensus Error Grid zones A and B
大体时间：Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)
Percentage of paired CGM-reference points falling within zones A and B of the Consensus Error Grid analysis, reported separately for the Anytime 5Pro and the Anytime 4Pro.
Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)

次要结果测量

结果测量
措施说明
大体时间
Sensor accuracy stability across wear phases (MARD and +/-20%/+/-20 mg/dL agreement)
大体时间：Days 1 to 16
MARD and the +/-20%/+/-20 mg/dL agreement rate calculated at each phase of the wear period (beginning, early middle, late middle, end), reported separately for the Anytime 5Pro and the Anytime 4Pro.
Days 1 to 16
Point accuracy stratified by rate of change (RoC) of glucose
大体时间：Days 1 to 16
Point accuracy stratified by rate of change of glucose concentration, categorised as < -2, -2 to < -1, -1 to < 0, 0 to 1, > 1 to 2, and > 2 mg/dL per minute, reported separately for the Anytime 5Pro and the Anytime 4Pro.
Days 1 to 16
Sensor accuracy across glucose concentration ranges (iCGM special control approach)
大体时间：Days 1 to 16
Accuracy across glucose ranges (<54, 54-70, 70-180, >180 mg/dL), following the integrated CGM (iCGM) special control approach: proportion of CGM readings within the absolute (mg/dL) criterion for reference values <=70 mg/dL and within the relative (%) criterion for reference values >70 mg/dL, with corresponding 95% lower confidence limits. Reported separately for the Anytime 5Pro and the Anytime 4Pro.
Days 1 to 16
Mean Absolute Difference (MAD) for glucose values <=70 mg/dL
大体时间：Days 1 to 16
Mean absolute difference (MAD) in mg/dL between CGM and reference for reference glucose values <=70 mg/dL, reported separately for the Anytime 5Pro and the Anytime 4Pro.
Days 1 to 16
Hypoglycaemic alert performance
大体时间：Days 1 to 16
True alert rate and detection rate at the hypoglycaemic threshold of 70 mg/dL (3.9 mmol/L), evaluated within a +/-15 minute window, reported separately for the Anytime 5Pro and the Anytime 4Pro.
Days 1 to 16
Hyperglycaemic alert performance
大体时间：Days 1 to 16
True alert rate and detection rate at the hyperglycaemic threshold of 200 mg/dL (11.1 mmol/L), evaluated within a +/-15 minute window, reported separately for the Anytime 5Pro and the Anytime 4Pro.
Days 1 to 16
Agreement rates at +/-15%/+/-15 mg/dL and +/-30%/+/-30 mg/dL
大体时间：Days 1 to 16
Proportion of paired CGM-reference points within +/-15%/+/-15 mg/dL and within +/-30%/+/-30 mg/dL of reference values, applying the same absolute/relative threshold methodology as the +/-20%/+/-20 mg/dL primary endpoint. Reported separately for the Anytime 5Pro and the Anytime 4Pro.
Days 1 to 16

其他结果措施

结果测量
措施说明
大体时间
Incidence, severity, and relatedness of adverse events and serious adverse events
大体时间：Day 1 to Day 17
Incidence, severity, and relatedness of all adverse events (AEs) and serious adverse events (SAEs), including adverse device effects. Safety findings attributed to the relevant device (Anytime 5Pro, Anytime 4Pro, or ambiguous/both) and reported per device in addition to the overall pooled summary.
Day 1 to Day 17
Incidence of device deficiencies and device-related adverse events
大体时间：Day 1 to Day 17
Incidence of device deficiencies and device-related adverse events, reported separately for the Anytime 5Pro and the Anytime 4Pro.
Day 1 to Day 17
Skin assessment findings at sensor insertion sites
大体时间：Day 1 to Day 17
Skin assessment findings at each of the two sensor insertion sites (Anytime 5Pro site and Anytime 4Pro site, evaluated independently) at each clinic visit and upon sensor removal: erythema, oedema, induration, pruritus, bruising, and infection.
Day 1 to Day 17
Participant satisfaction and usability (QUSS-CGM-based questionnaires)
大体时间：Day 17 (Visit 6)
Participant satisfaction and usability assessed by two device-specific questionnaires (one per device) based on the QUSS-CGM and adapted for the masked-application context, covering ease of sensor insertion and removal, wearing comfort, daily-life impact, sensor size and adhesive performance, and overall user acceptance. Analysed and reported separately for the Anytime 5Pro and the Anytime 4Pro.
Day 17 (Visit 6)
Sensor functional survival (Kaplan-Meier)
大体时间：Through sensor wear period (up to 16 days for Anytime 5Pro; up to 15 days for Anytime 4Pro)
Sensor functional survival estimated using Kaplan-Meier methodology, calculated separately for the Anytime 5Pro (over the 16-day labelled wear period) and the Anytime 4Pro (over the 15-day labelled wear period).
Through sensor wear period (up to 16 days for Anytime 5Pro; up to 15 days for Anytime 4Pro)
Lag time between interstitial fluid glucose and venous blood glucose
大体时间：Days 1 to 16
Lag time between interstitial fluid glucose measured by each CGM system and venous blood glucose measured by the reference analyzer, evaluated separately for each device in accordance with the IFCC Working Group recommendations on the clinical performance evaluation of CGM systems.
Days 1 to 16

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yuwell Group

合作者

Jiangsu Yuwell POCTech Biotechnology Co., Ltd..

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月20日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PMCF-2026-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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