Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2
Conditions
Keywords
continuous glucose monitoring, CGM, interstitial glucose, MARD, sensor accuracy, post-market clinical follow-up, medical device
Brief 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.
Detailed description
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.
Interventions
DEVICEReference 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
Yuwell Group
Jiangsu Yuwell POCTech Biotechnology Co., Ltd..
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Device assignment is open-label. However, participants are masked to all real-time CGM output (glucose values, trends, and alerts) throughout the wear period via masked-mode operation of the companion application, so that investigational device readings cannot influence the participants' glucose management. This constitutes outcome masking only, not blinding of device assignment.
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Relative Difference (MARD) between CGM and reference glucose | Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16) | MARD across the reportable glucose range (30-500 mg/dL), reported separately for each device. Calculated as the mean of the absolute values of (CGM value - reference value) / reference value, expressed as a percentage, across all evaluable paired CGM-reference points. Reported for the Anytime 5Pro and the Anytime 4Pro independently. |
| Agreement rate within +/-20%/+/-20 mg/dL of reference glucose | Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16) | Proportion of paired CGM-reference points within +/-20 mg/dL of the reference for reference values \<=80 mg/dL, or within +/-20% of the reference for reference values \>80 mg/dL, reported separately for the Anytime 5Pro and the Anytime 4Pro. |
| Proportion of paired points in Consensus Error Grid zones A and B | Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16) | Percentage of paired CGM-reference points falling within zones A and B of the Consensus Error Grid analysis, reported separately for the Anytime 5Pro and the Anytime 4Pro. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensor accuracy stability across wear phases (MARD and +/-20%/+/-20 mg/dL agreement) | Days 1 to 16 | MARD and the +/-20%/+/-20 mg/dL agreement rate calculated at each phase of the wear period (beginning, early middle, late middle, end), reported separately for the Anytime 5Pro and the Anytime 4Pro. |
| Point accuracy stratified by rate of change (RoC) of glucose | Days 1 to 16 | Point accuracy stratified by rate of change of glucose concentration, categorised as \< -2, -2 to \< -1, -1 to \< 0, 0 to 1, \> 1 to 2, and \> 2 mg/dL per minute, reported separately for the Anytime 5Pro and the Anytime 4Pro. |
| Sensor accuracy across glucose concentration ranges (iCGM special control approach) | Days 1 to 16 | Accuracy across glucose ranges (\<54, 54-70, 70-180, \>180 mg/dL), following the integrated CGM (iCGM) special control approach: proportion of CGM readings within the absolute (mg/dL) criterion for reference values \<=70 mg/dL and within the relative (%) criterion for reference values \>70 mg/dL, with corresponding 95% lower confidence limits. Reported separately for the Anytime 5Pro and the Anytime 4Pro. |
| Mean Absolute Difference (MAD) for glucose values <=70 mg/dL | Days 1 to 16 | Mean absolute difference (MAD) in mg/dL between CGM and reference for reference glucose values \<=70 mg/dL, reported separately for the Anytime 5Pro and the Anytime 4Pro. |
| Hypoglycaemic alert performance | Days 1 to 16 | True alert rate and detection rate at the hypoglycaemic threshold of 70 mg/dL (3.9 mmol/L), evaluated within a +/-15 minute window, reported separately for the Anytime 5Pro and the Anytime 4Pro. |
| Hyperglycaemic alert performance | Days 1 to 16 | True alert rate and detection rate at the hyperglycaemic threshold of 200 mg/dL (11.1 mmol/L), evaluated within a +/-15 minute window, reported separately for the Anytime 5Pro and the Anytime 4Pro. |
| Agreement rates at +/-15%/+/-15 mg/dL and +/-30%/+/-30 mg/dL | Days 1 to 16 | Proportion of paired CGM-reference points within +/-15%/+/-15 mg/dL and within +/-30%/+/-30 mg/dL of reference values, applying the same absolute/relative threshold methodology as the +/-20%/+/-20 mg/dL primary endpoint. Reported separately for the Anytime 5Pro and the Anytime 4Pro. |
Contacts
CONTACTZheng LI
Outcome results
None listed