Clinical Trial

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

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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.
Trial Details
NCT Number NCT07645313
Lead Sponsor Yuwell Group
Collaborators: Jiangsu Yuwell POCTech Biotechnology Co., Ltd..
Conditions Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2
Enrollment 70 participants
Start Date 2026-07-20
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-12