NCT07645313
Accuracy and Safety of Anytime 5Pro and Anytime 4Pro CGM Systems in Adults With Diabetes
Not Yet Recruiting · Not Applicable · Yuwell Group · registry updated 2026-06-12
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Diagnosis of type 1 or type 2 diabetes mellitus, documented in medical records, with diabetes established at least 6 months prior to Day 1.
- Age \>= 18 years at the time of informed consent.
- 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).
- Feasibility of establishing forearm venous access for repeated blood sampling.
- Haematocrit \<= 70%.
- For T1D participants: prior experience with a CGM system (any brand).
Exclusion
- Skin disorders at the prospective sensor insertion site (posterior-lateral upper arm), including scarring, redness, swelling, infection, or tattoos.
- Known allergies to alcohol-based disinfectants or medical adhesives.
- Coagulation abnormalities or bleeding disorders, or current use of anticoagulant therapy (except low-dose aspirin).
- Current pregnancy, suspected pregnancy, or lactation.
- History of epilepsy or psychiatric disorders that may compromise investigation compliance or subject safety during glucose manipulation procedures.
- Severe hepatic or renal insufficiency.