Accuracy and Safety of Anytime 5Pro and Anytime 4Pro CGM Systems in Adults With Diabetes (NCT07645313) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Accuracy and Safety of Anytime 5Pro and Anytime 4Pro CGM Systems in Adults With Diabetes
70 participantsStarted 2026-07-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing the accuracy of two specific CGM devices called Anytime 5Pro and Anytime 4Pro — are either of these devices likely to become options I could use long-term, and how does participating in an accuracy study like this differ from a trial testing a new treatment?
2Since this study isn't recruiting yet, how long might it realistically be before it opens, and would it make more sense for me to start with a currently approved CGM device while I wait?
3The trial measures something called Mean Absolute Relative Difference and uses a Consensus Error Grid — can you explain what those accuracy benchmarks mean in practice, and how accurate these devices appear to be compared to CGMs I could already access today?
4Because this is a Phase NA device accuracy study rather than a drug or therapy trial, what are the main risks or burdens involved — for example, will I need frequent blood draws to provide reference glucose readings for comparison?
5Given that I have Type 1 or Type 2 diabetes, is my current glucose monitoring approach already adequate, or is there a reason it might be worth discussing whether a study like this could fit into my overall care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Absolute Relative Difference (MARD) between CGM and reference glucose
Timeframe: Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)
2
Agreement rate within +/-20%/+/-20 mg/dL of reference glucose
Timeframe: Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)
3
Proportion of paired points in Consensus Error Grid zones A and B
Timeframe: Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)