Diabetes MellitusNCT03515421
Project Frazier 3 Regulatory Clinical Evaluation
A study testing Frazier 3 Verio and Frazier 3 UltraPlus in people with Diabetes Mellitus and Healthy Volunteers, run by LifeScan Scotland Ltd at 4 sites in 2 countries.
Trial summary
Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs) Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Healthy Volunteers
- What is being tested?
- Frazier 3 Verio and Frazier 3 UltraPlus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Apr 2018to 18 Jun 2018
- Phase
- Interventional
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Summary of Inclusion Criteria
- Age - Subject is at least 12 years old.
- Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
- Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
- Language - Subject reads and understands local language
- SMBG status confirmed
- Subject agrees to complete all aspects of the study
Summary of exclusion criteria
- Conflict of Interest
- Pregnancy - Subject is pregnant (as confirmed by Subject)
- User Performance Accuracy Testing - Technical Expertise
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom3 sites
Diabetes Centre
Birmingham, B9 5SS
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Centre for Health Science
Inverness, IV2 3JH
About this study
Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)
Read the detailed description
User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.
- Conditions
- Diabetes Mellitus, Healthy Volunteers
- Being tested
- Frazier 3 Verio, Frazier 3 UltraPlus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frazier 3 VerioDevice
In vitro diagnostic device (IVDD)
Frazier 3 UltraPlusDevice
In vitro diagnostic device (IVDD)
| Study group | Role | What they receive |
|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Intervention: Blood Glucose monitoring Systems (BGMSs): Frazier 3 Verio and Frazier 3 UltraPLus.
Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) Receives: Device: Frazier 3 Verio; Device: Frazier 3 UltraPlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.
UP evaluation of blood glucose monitoring systems compared to a reference instrument. BGMSs samples collected by subject and reference samples collected by HCP ( Health Care Professional)
Measured: Up to 1 hour
System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.
Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.
Measured: Up to 1 hour
System Use Evaluation questionnaire
Assessment of how the patient uses the BGMS.
Measured: Up to 15 minutes
Instructions for Use Evaluation questionnaire.
Questionnaires to assess the effectiveness of the instructions for use.
Measured: Up to 10 days.
Marketing Claims Evaluation questionnaire.
Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start9 Apr 2018
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan Scotland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for Diabetes-Technology GmbH
- Responsible party
- Sponsor
- Investigators
- Lorna Stewart, Study director, LifeScan Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515421
- Sponsor's protocol ID
- 3165622
- Status last verified
- Sep 2020
- First submitted
- 10 Apr 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Katz LB, Stewart L, Guthrie B, Cameron H. Patient Satisfaction With a New, High Accuracy Blood Glucose Meter That Provides Personalized Guidance, Insight, and Encouragement. J Diabetes Sci Technol. 2020 Mar;14(2):318-323. doi: 10.1177/1932296819867396. Epub 2019 Aug 2.
PubMed 31375031
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Frazier 3 Regulatory Clinical Evaluation
- ClinicalTrials.gov ID
- NCT03515421
- Acronym / sponsor ID
- 3165622
- Conditions
- Diabetes Mellitus, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- LifeScan Scotland LtdIndustry (pharma, biotech, devices)
- Collaborators
- Institute for Diabetes-Technology GmbH
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 3 May 2018 (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.
Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)
Detailed description
User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Device: Frazier 3 Verio, Device: Frazier 3 UltraPlusIntervention: Blood Glucose monitoring Systems (BGMSs): Frazier 3 Verio and Frazier 3 UltraPLus. Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Frazier 3 VerioIn vitro diagnostic device (IVDD) | Device | Blood Glucose monitoring System (BGMS) |
| Frazier 3 UltraPlusIn vitro diagnostic device (IVDD) | Device | Blood Glucose monitoring System (BGMS) |
Primary outcome
User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.
Time frame: Up to 1 hour
UP evaluation of blood glucose monitoring systems compared to a reference instrument. BGMSs samples collected by subject and reference samples collected by HCP ( Health Care Professional)
System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.
Time frame: Up to 1 hour
Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.
System Use Evaluation questionnaire
Time frame: Up to 15 minutes
Assessment of how the patient uses the BGMS.
Instructions for Use Evaluation questionnaire.
Time frame: Up to 10 days.
Questionnaires to assess the effectiveness of the instructions for use.
Marketing Claims Evaluation questionnaire.
Time frame: Up to 10 days
Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.
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 10 Sep 2020.
- Derived from this study: PubMed 31375031Katz LB, Stewart L, Guthrie B, Cameron H. Patient Satisfaction With a New, High Accuracy Blood Glucose Meter That Provides Personalized Guidance, Insight, and Encouragement. J Diabetes Sci Technol. 2020 Mar;14(2):318-323. doi: 10.1177/1932296819867396. Epub 2019 Aug 2.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 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.
Lorna Stewart study director
LifeScan Scotland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frazier 3 Verio and Frazier 3 UltraPlus in people with Diabetes Mellitus and Healthy Volunteers, run by LifeScan Scotland Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Germany. 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?
User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument. (time frame: Up to 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515421, which also lists 1 linked publication.
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 10 Sep 2020.