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NCT07645313

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

Sponsor: Yuwell Group

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-20

Completion Date

2027-01-31

Last Updated

2026-06-12

Healthy Volunteers

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.

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. \-