Diabetes MellitusCONVERTNCT04262700
Customer Outcomes & Value Experiencing A New Monitoring Technology
A study testing LifeScan's new BGMS in people with Diabetes Mellitus, run by LifeScan Scotland Ltd at 2 sites in United Kingdom.
Trial summary
To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- LifeScan's new BGMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Feb 2020to 1 Oct 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with Type 1 diabetes mellitus or Type 2 diabetes mellitus for ≥ 3 month prior to screening
- Currently performing self-monitoring of blood glucose (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
- Currently using a continuous or flash glucose monitoring
- 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or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn.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
2 sites in 1 country.
Kirsty Macleod contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
Alison Sudworth
Dr. Nicola Zammitt
- Recruiting
Highland Diabetes Institute
Inverness, IV2 3JH
David MacFarlane, MD
David MacFarlane, MD
About this study
To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.
- Conditions
- Diabetes Mellitus
- Being tested
- LifeScan's new BGMS
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeScan's new BGMSDevice
LifeScan new Blood Glucose Monitoring System (BGMS)
| Study group | Role | What they receive |
|---|---|---|
| Intervention 01 | Experimental | Subjects use new LifeScan provided BGMS for 12 weeks. Receives: Device: LifeScan's new BGMS |
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 new BGMS compared to subjects' pre-study glycemic control
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 posted10 Feb 2020
- Study start7 Feb 2020
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeScan Scotland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262700
- Sponsor's protocol ID
- FILE-PROT-005120
- Acronym
- CONVERT
- Status last verified
- Sep 2020
- First submitted
- 7 Feb 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Device being used in the study is CE marked and will be used as intended therefore risk is minimal. What? Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices). When? Beginning 9 months and ending 36 months following article publication. With whom? Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis. By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available from our archive but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found by reaching out to the study contact listed. What other documents will be available?Abbreviated CSR may be provided upon request and assessment by the company.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customer Outcomes & Value Experiencing A New Monitoring Technology
- ClinicalTrials.gov ID
- NCT04262700
- Acronym / sponsor ID
- CONVERT / FILE-PROT-005120
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- LifeScan Scotland LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 10 Feb 2020 (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.
To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention 01 | Experimental | Device: LifeScan's new BGMSSubjects use new LifeScan provided BGMS for 12 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Type 1 diabetes mellitus or Type 2 diabetes mellitus for ≥ 3 month prior to screening
- Currently performing self-monitoring of blood glucose (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)
- Currently using a continuous or flash glucose monitoring
- 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 |
|---|---|---|
| LifeScan's new BGMSLifeScan new Blood Glucose Monitoring System (BGMS) | Device | Intervention 01 |
Primary outcome
A1c change from baseline after 12 weeks
Time frame: 12 weeks
A1c change from baseline after 12 weeks in subjects using new BGMS compared to subjects' pre-study glycemic control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Yes. Device being used in the study is CE marked and will be used as intended therefore risk is minimal. What? Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices). When? Beginning 9 months and ending 36 months following article publication. With whom? Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis. By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available from our archive but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found by reaching out to the study contact listed. What other documents will be available?Abbreviated CSR may be provided upon request and assessment by the company.
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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.
Kirsty Macleod contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeScan's new BGMS in people with Diabetes Mellitus, run by LifeScan Scotland Ltd at 2 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: status not confirmed, as of the sponsor's last update on 9 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 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Grady (01463 721000, MGRADY@lifescan.com), or a site near the patient. 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?
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 9 Sep 2020.