ClinicalTrials.gg
CompletedNCT06258005Updated Jan 17, 2025

PocDoc Lipids Out-of-Surgery Study

An observational study in Dyslipidemias, sponsored by Vital Signs Solutions Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Vital Signs Solutions Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,256
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study seeks to improve access to lipid testing in out-of-surgery locations using PocDoc, a UKCA approved IVD device that measures a full 5 marker lipid panel using a smartphone or tablet. The study will investigate whether PocDoc can close the gap in people not tested by exploring 3 new out-of-surgery methods:

  1. Lipid testing for high-risk individuals on existing CVD register who have not attended in-surgery appointments
  2. Footfall lipid testing conducted in pharmacy or at community events
  3. Corporate wellness lipid testing performed by employers for employees as part of an organised corporate wellness check
Read the detailed description

Lipid testing in out-of-surgery (OOS) locations using a digital lipid measuring device called PocDoc promises to increase access to lipid testing and cardiovascular disease health assessment. PocDoc lipids comprises a smartphone-compatible disposable microchip test strip which uses proprietary colorimetric microfluidic technology to accurately detect lipid biomarkers from a droplet of blood. PocDoc Lipids Professional was launched in 2022 to enable professional users to perform lipid screens as part of lifestyle or preventative healthcare screens. The investigator's hypothesise that providing easier, more cost-effective access to lipid testing at scale, without patients having to attend the GP surgery could:

  1. Identify previously unidentified patients (including key "hard to reach" cohorts) who have elevated lipid levels and get them into a lipid lowering clinical pathway which reduces risk of CVD event
  2. Enable increase in "treat to target" and move more patients from low / medium intensity statin onto high intensity, which reduces risk of CVD events
  3. Identify more cases of undiagnosed FH and getting those patients into a lipid lowering pathway

The SBRI 21 Phase 3 program is funding this collaborative project in partnership with SMASH PCN and AHSN NENC with the objective of increasing access to lipid testing in those geographies.

02

Conditions studied

  • Dyslipidemias

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03

In context

Dyslipidemias

1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.

This study's enrollment of 4,256 is above the median of 600 across 212 observational studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Vital Signs Solutions Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Individuals in the primary prevention setting who have not previously had a cardiovascular event such as a heart attack or stroke as well as individuals in the secondary prevention setting who have had previous cardiovascular events.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Consent indicated from within PocDoc app
  • Subjects are legally competent and capable to understand character, meaning and consequences of the study
  • Subjects own an approved mobile device (these will be available at the time of the study on the PocDoc website and the central team will verify individuals have appropriate mobile devices before PocDoc tests are sent to them)

Exclusion criteria

Exclusion Criteria:

  • Being unable to give informed consent
  • \< 18 years or > 85 years
  • Legally incompetent
  • Language barriers potentially compromising an adequate compliance with study procedures
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,256 participants (actual)
Patient registry
No

Groups and cohorts

  • PocDoc testing of primary care patients

    There are significant numbers of patients in primary care who should be given annual lipid checks who are not receiving them. PocDoc is a digital rapid 5-marker lipid panel that uses a smartphone as a diagnostic reader. PocDoc tests will be offered to patients overdue their annual lipid check either in surgery, in the community or in their own home.

    Diagnostic Test: PocDoc

  • Pocdoc testing in the community

    Providing lipid testing in community settings such as in pharmacy may offer a more attractive solution to consumers. This hypothesis will be tested by offering PocDoc lipid tests in a community setting.

    Diagnostic Test: PocDoc

  • PocDoc testing in workplaces

    Providing lipid testing as part of a health wellness screen in employees workplaces in may offer an attractive solution to consumers needing their lipid levels check. This hypothesis will be tested by offering PocDoc lipid tests as part of corporate wellness screens.

    Diagnostic Test: PocDoc

Interventions

  • Diagnostic testPocDoc

    PocDoc is a digital rapid 5-marker lipid test

06

What researchers measure

Primary outcomes

  1. Overall response rate

    Number and proportion of individuals contacted who conduct a PocDoc test

    Time frame: Day 1 - one single test done at one timepoint

  2. Achieved response rate

    Number and proportion of individuals who conduct a PocDoc test that have dyslipidaemia

    Time frame: Day 1 - one single test done at one timepoint

Secondary outcomes

  1. PocDoc experience

    Number (N) and proportion (%) of individuals reporting a positive experience with the PocDoc testing pathway

    Time frame: Day 1 - one single test done at one timepoint

  2. PocDoc value

    c. Number (N) and proportion (%) of individuals reporting improvements vs in surgery testing procedure with regards to convenience, speed of testing, testing process

    Time frame: Day 1 - one single test done at one timepoint

07

Study locations

1 site
  • PocDoc Ltd
    Cambridge, CB4 0FW, United Kingdom
08

References and documents

Publications

  • Roest K, Kelly C, Marshall T, Whales E, Taylor L, Hatfield R, Bunyan K, Dawson L, Roest S, Newton J. Rapid community "Healthy Heart" screening to identify people at high risk of cardiovascular events. PLoS One. 2026 Sep 29;21(9):e0358999. doi: 10.1371/journal.pone.0358999. eCollection 2026. PubMed 42809611 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2023 to primary completion in Sep 2024, 14 months.

Of 29 industry-sponsored observational studies under Dyslipidemias, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 39. This study's 14 months is below that.

Counting every sponsor, half of 81 studies reached it within 36 months; a quarter within 23 and three quarters within 118.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2024
First posted
Feb 14, 2024
StartActual
Jun 23, 2023
Primary completionActual
Sep 1, 2024
CompletionActual
Jan 1, 2025
Last update
Jan 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06258005
Lead sponsor
Vital Signs Solutions Ltd
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Jun 23, 2023
Primary completion
Sep 1, 2024
Completion
Jan 1, 2025
Last update
Jan 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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