Diabetes MellitusNCT02767336
Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
A study testing Blood Glucose Monitoring System. in people with Diabetes Mellitus, run by LifeScan at 4 sites in United Kingdom.
Trial summary
Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Blood Glucose Monitoring System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Apr 2016to May 2016
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Summary of Inclusion Criteria:
- Able to voluntarily provide written informed consent to participate in the study.
- User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
- For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45.
Summary of Exclusion Criteria:
- Female subjects who are pregnant or lactating.
- Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
- User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
BioKinetic Europe Ltd
Belfast, Antrim, BT2 7BA
Diabetes Centre, Heartlands Hospital
Birmingham, B9 5SS
NHS Lothian
Edinburgh, EH16 4SA
Highland Diabetes Institute
Inverness, IV2 3JH
About this study
Official title: Project Bloom Regulatory Clinical Evaluation - System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation
Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.
- Conditions
- Diabetes Mellitus
- Being tested
- Blood Glucose Monitoring System.
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Glucose Monitoring System.Device
In vitro diagnostic medical device
| Study group | Role | What they receive |
|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) Receives: Device: Blood Glucose Monitoring System. |
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. Samples collected by subject and 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 6 days.
Marketing Claims Evaluation questionnaire.
Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.
Measured: Up to 6 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio-Kinetic Europe, Ltd.
- Responsible party
- Sponsor
- Investigators
- Lorna Stewart, Study director, LifeScan Scotland Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767336
- Sponsor's protocol ID
- 3141352 and 3141353
- Status last verified
- Sep 2016
- First submitted
- 6 May 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Bloom Regulatory Clinical Evaluation - System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation
- ClinicalTrials.gov ID
- NCT02767336
- Acronym / sponsor ID
- 3141352 and 3141353
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Collaborators
- Bio-Kinetic Europe, Ltd.
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 May 2016 (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.
Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.
Study design
- 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: Blood Glucose Monitoring System.Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Blood Glucose Monitoring System.In vitro diagnostic medical device | 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. Samples collected by subject and 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 6 days.
Questionnaires to assess the effectiveness of the instructions for use.
Marketing Claims Evaluation questionnaire.
Time frame: Up to 6 days.
Assess Lay User Acceptance of the Bloom BGMS 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 14 Sep 2016.
- Individual participant dataSharing planned: No
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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 Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Glucose Monitoring System. in people with Diabetes Mellitus, run by LifeScan at 4 sites in United Kingdom.
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 14 Sep 2016. 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. 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?
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 14 Sep 2016; AzTrials last refreshed its copy on 29 Oct 2026.