Diabetes MellitusNCT02929654
Assessment of Blood Glucose Monitoring Devices With New Insight Features
A study testing OneTouch Verio®, OneTouch Verio® Flex and Subject's Own Blood Glucose Meter in people with Diabetes Mellitus, run by LifeScan at 3 sites in United Kingdom.
Trial summary
To investigate whether novel insight features in new BGMs can improve glycemic control. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- OneTouch Verio®, OneTouch Verio® Flex and Subject's Own Blood Glucose Meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Oct 2016to 22 Jun 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening
- Currently performing SMBG at home for diabetes management decisions
- Willingness to notify the study staff if they become pregnant during the study
- Willing to sign an informed consent
Who cannot join
- Is unlikely to be compliant with the diabetes regimen in the opinion of study staff
- Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn
- Conflict of Interest
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Diabetes Centre, Heartlands Hospital
Birmingham, B9 5SS
NHS Lothian
Edinburgh, EH16 4SA
Highland Diabetes Institute
Inverness, IV2 3JH
About this study
To investigate whether novel insight features in new BGMs can improve glycemic control.
- Conditions
- Diabetes Mellitus
- Being tested
- OneTouch Verio®, OneTouch Verio® Flex, Subject's Own Blood Glucose Meter
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneTouch Verio®Device
Colour Enhanced Blood Glucose Meter.
OneTouch Verio® FlexDevice
Colour Enhanced Blood Glucose Meter.
Subject's Own Blood Glucose MeterDevice
Subject's Own Blood Glucose Meter
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks. Receives: Device: Subject's Own Blood Glucose Meter |
| OneTouch Verio® | Experimental | Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks Receives: Device: OneTouch Verio® |
| Intervention 02 | Experimental | Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks. Receives: Device: OneTouch Verio® Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c change from baseline after 12 weeks
A1c change from baseline after 12 weeks in subjects using BGMs with color range indicator and/or pattern messaging tools (i.e., OneTouch Verio® Flex and OneTouch Verio® combined) compared to subjects with either T1 or T2DM using their current BGM, i.e., without color range indicator and/or pattern messaging tools.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Grady, Study director, LifeScan Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929654
- Sponsor's protocol ID
- 3150067
- Status last verified
- Aug 2017
- First submitted
- 7 Oct 2016
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Grady M, Katz LB, Levy BL. Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study). J Diabetes Sci Technol. 2018 Nov;12(6):1211-1219. doi: 10.1177/1932296818775755. Epub 2018 May 31.
PubMed 29848106
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Blood Glucose Monitoring Devices With New Insight Features
- ClinicalTrials.gov ID
- NCT02929654
- Acronym / sponsor ID
- 3150067
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 11 Oct 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.
To investigate whether novel insight features in new BGMs can improve glycemic control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Subject's Own Blood Glucose MeterSubject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks. |
| OneTouch Verio® | Experimental | Device: OneTouch Verio®Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks |
| Intervention 02 | Experimental | Device: OneTouch Verio® FlexSubjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening
- Currently performing SMBG at home for diabetes management decisions
- Willingness to notify the study staff if they become pregnant during the study
- Willing to sign an informed consent
Key exclusion criteria (3 listed)
- Is unlikely to be compliant with the diabetes regimen in the opinion of study staff
- Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn
- Conflict of Interest
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 |
|---|---|---|
| OneTouch Verio®Colour Enhanced Blood Glucose Meter. | Device | OneTouch Verio® |
| OneTouch Verio® FlexColour Enhanced Blood Glucose Meter. | Device | Intervention 02 |
| Subject's Own Blood Glucose MeterSubject's Own Blood Glucose Meter | Device | Control |
Primary outcome
A1c change from baseline after 12 weeks
Time frame: 12 weeks
A1c change from baseline after 12 weeks in subjects using BGMs with color range indicator and/or pattern messaging tools (i.e., OneTouch Verio® Flex and OneTouch Verio® combined) compared to subjects with either T1 or T2DM using their current BGM, i.e., without color range indicator and/or pattern messaging tools.
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 15 Aug 2017.
- Derived from this study: PubMed 29848106Grady M, Katz LB, Levy BL. Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study). J Diabetes Sci Technol. 2018 Nov;12(6):1211-1219. doi: 10.1177/1932296818775755. Epub 2018 May 31.
- 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.
Mike Grady study director
LifeScan Scotland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OneTouch Verio®, OneTouch Verio® Flex and Subject's Own Blood Glucose Meter in people with Diabetes Mellitus, run by LifeScan at 3 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?
The sponsor lists 4 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
A1c change from baseline after 12 weeks (time frame: 12 weeks). 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 NCT02929654, 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 15 Aug 2017.