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

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.

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.

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.

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