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

NCT07645313 | Not Yet Recruiting

• 1 other identifier: PMCF-2026-001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2

Keywords

continuous glucose monitoring, CGM; interstitial glucose; MARD; sensor accuracy; post-market clinical follow-up; medical device

Outcome Measures

Primary Outcomes (3)

• Mean Absolute Relative Difference (MARD) between CGM and reference glucose

  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.

  Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)

• Agreement rate within +/-20%/+/-20 mg/dL of reference glucose

  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.

  Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)

• Proportion of paired points in Consensus Error Grid zones A and B

  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.

  Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)

Secondary Outcomes (7)

• Sensor accuracy stability across wear phases (MARD and +/-20%/+/-20 mg/dL agreement)

  Days 1 to 16

• Point accuracy stratified by rate of change (RoC) of glucose

  Days 1 to 16

• Sensor accuracy across glucose concentration ranges (iCGM special control approach)

  Days 1 to 16

• Mean Absolute Difference (MAD) for glucose values <=70 mg/dL

  Days 1 to 16

• Hypoglycaemic alert performance

  Days 1 to 16

Other Outcomes (6)

• Incidence, severity, and relatedness of adverse events and serious adverse events

  Day 1 to Day 17

• Incidence of device deficiencies and device-related adverse events

  Day 1 to Day 17

• Skin assessment findings at sensor insertion sites

  Day 1 to Day 17

Study Arms (1)

Dual CGM wear (Anytime 5Pro + Anytime 4Pro)

EXPERIMENTAL

Dual CGM wear (Anytime 5Pro + Anytime 4Pro)

Device: Reference venous blood sampling (YSI 2500)

Interventions

Reference venous blood sampling (YSI 2500) DEVICE

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.

Dual CGM wear (Anytime 5Pro + Anytime 4Pro)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Written informed consent obtained prior to any investigation-related procedures.

You may not qualify if:

• 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.
• Current use of medications known to interfere with CGM readings, including ascorbic acid (vitamin C) supplementation \>1000 mg/day.
• Concurrent participation in another interventional device or drug trial, or participation within the past 30 days.
• Known drug or alcohol abuse.
• 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.
• Planned magnetic resonance imaging (MRI), computed tomography (CT), X-ray examination, or diathermic therapy during the sensor wear period.

Sponsors & Collaborators

• Yuwell Group: lead
• Jiangsu Yuwell POCTech Biotechnology Co., Ltd..: collaborator

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Zheng LI

CONTACT

+86-13801115651; lizheng1@yuyue.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06