Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2NCT07645313
Accuracy and Safety of Anytime 5Pro and Anytime 4Pro CGM Systems in Adults With Diabetes
A study testing Reference venous blood sampling (YSI 2500) in people with Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2, run by Yuwell Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2
- What is being tested?
- Reference venous blood sampling (YSI 2500)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Reference venous blood sampling (YSI 2500)
- Keywords
- continuous glucose monitoring, CGM, interstitial glucose, MARD, sensor accuracy, post-market clinical follow-up, medical device
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dual CGM wear (Anytime 5Pro + Anytime 4Pro) | Experimental | Dual CGM wear (Anytime 5Pro + Anytime 4Pro) Receives: Device: Reference venous blood sampling (YSI 2500) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Days 1 to 16
Point accuracy stratified by rate of change (RoC) of glucose
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.
Measured: Days 1 to 16
Sensor accuracy across glucose concentration ranges (iCGM special control approach)
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.
Measured: Days 1 to 16
Mean Absolute Difference (MAD) for glucose values <=70 mg/dL
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.
Measured: Days 1 to 16
Hypoglycaemic alert performance
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.
Measured: Days 1 to 16
Hyperglycaemic alert performance
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.
Measured: Days 1 to 16
Agreement rates at +/-15%/+/-15 mg/dL and +/-30%/+/-30 mg/dL
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.
Measured: Days 1 to 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuwell Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Yuwell POCTech Biotechnology Co., Ltd..
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645313
- Sponsor's protocol ID
- PMCF-2026-001
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07645313
- Acronym / sponsor ID
- PMCF-2026-001
- Keywords
- continuous glucose monitoring, CGM, interstitial glucose, MARD, sensor accuracy, post-market clinical follow-up, medical device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yuwell GroupIndustry (pharma, biotech, devices)
- Collaborators
- Jiangsu Yuwell POCTech Biotechnology Co., Ltd..
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Dual CGM wear (Anytime 5Pro + Anytime 4Pro) | Experimental | Device: Reference venous blood sampling (YSI 2500)Dual CGM wear (Anytime 5Pro + Anytime 4Pro) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reference 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. | Device | Dual CGM wear (Anytime 5Pro + Anytime 4Pro) |
Primary outcome
Mean Absolute Relative Difference (MARD) between CGM and reference glucose
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Sensor accuracy stability across wear phases (MARD and +/-20%/+/-20 mg/dL agreement)
Time frame: Days 1 to 16
Point accuracy stratified by rate of change (RoC) of glucose
Time frame: Days 1 to 16
Sensor accuracy across glucose concentration ranges (iCGM special control approach)
Time frame: Days 1 to 16
Mean Absolute Difference (MAD) for glucose values <=70 mg/dL
Time frame: Days 1 to 16
Hypoglycaemic alert performance
Time frame: Days 1 to 16
Hyperglycaemic alert performance
Time frame: Days 1 to 16
Agreement rates at +/-15%/+/-15 mg/dL and +/-30%/+/-30 mg/dL
Time frame: Days 1 to 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Reference venous blood sampling (YSI 2500) in people with Diabetes Mellitus, Type 1 | Diabetes Mellitus, Type 2, run by Yuwell Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng LI (+86-13801115651, lizheng1@yuyue.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Relative Difference (MARD) between CGM and reference glucose (time frame: Paired measurements collected during four in-clinic sessions across the sensor wear period (Days 2 to 16)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.