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

NCT07645313 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-06-12

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Jiangsu Yuwell POCTech Biotechnology Co., Ltd..

    collaborator UNKNOWN

  • Yuwell Group

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2027-01-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645313 on ClinicalTrials.gov