Blood Glucose MeasurementNCT01795625
OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China
An observational study of Blood Glucose Measurement, run by Johnson & Johnson Medical, China at 2 sites in China.
Trial summary
The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Glucose Measurement
- How many people
- 301 participants
- Where
- 2 sitesChina
- Study dates
- 31 Aug 2012to 31 Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The study population will consist of at least 240 diabetic subjects (type 1 or type 2) study-wide at two clinical sites.
Who may be able to join
- Subject is at least 18 years of age.
- Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes)
- Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study.
- Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure.
- Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure.
- Subject agrees to provide demographic and medical history information and give access to medical records where appropriate.
Who cannot join
- Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products.
- Subject has already participated in this study.
- Subject is known pregnant
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai First People's Hospital
Shanghai
Shanghai Jiaotong University, medical school affiliated Third People's Hospital
Shanghai
About this study
Official title: A Multi-centre, Open Clinical Evaluation to Determine Professional Clinical Accuracy Comparing the OneTouch® Verio™Pro+ Blood Glucose Results With the YSI 2300 Analyzer.
The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional.
- Conditions
- Blood Glucose Measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
• Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample
August 20,2012~October 14,2012
Measured: 56days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study start31 Aug 2012
- Primary completion31 Oct 2012
- Study completion31 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose MeasurementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongde Peng, Professor, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineFengling Chen, Professor, Principal investigator, Shanghai Jiaotong University, medical school affiliated Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795625
- Sponsor's protocol ID
- LFS-201201
- Status last verified
- Aug 2023
- First submitted
- 18 Feb 2013
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open Clinical Evaluation to Determine Professional Clinical Accuracy Comparing the OneTouch® Verio™Pro+ Blood Glucose Results With the YSI 2300 Analyzer.
- ClinicalTrials.gov ID
- NCT01795625
- Acronym / sponsor ID
- LFS-201201
- Conditions
- Blood Glucose Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical, ChinaIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2012 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- Study completion
- 31 Oct 2012 (actual)
- First posted
- 20 Feb 2013 (estimated)
- 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.
The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of at least 240 diabetic subjects (type 1 or type 2) study-wide at two clinical sites.
Key inclusion criteria (6 listed)
- Subject is at least 18 years of age.
- Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes)
- Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study.
- Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure.
- Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure.
Key exclusion criteria (3 listed)
- Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products.
- Subject has already participated in this study.
- Subject is known pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample
Time frame: 56days
August 20,2012~October 14,2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
Related trials for Blood Glucose Measurement
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes
Prediabetes, Lipid Profile
Not yet recruitingObservational study
Perioperative Hypoglycemia in Diabetic Patients Undergoing Vitrectomy: a Masked CGM Prospective Observational Study
Diabetes Mellitus, Hypoglycemia
Active, not recruiting
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Type 2 Diabetes Mellitus, Obesity
Recruiting
Study Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air
Type 2 Diabetes
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. This study is not recruiting at the moment.
Yongde Peng, Professor principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Fengling Chen, Professor principal investigator
Shanghai Jiaotong University, medical school affiliated Third People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Glucose Measurement, run by Johnson & Johnson Medical, China at 2 sites in China.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample (time frame: 56days). 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 21 Aug 2023.