User Evaluation of a Home-collection Kit for People With Diabetes
NCT ID: NCT06038669
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-02-20
2025-12-31
Brief Summary
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Poor disease control is associated with a range of long-term health conditions which have a severe impact upon quality of life and are responsible for the increased morbidity and mortality associated with the disease.
Healthcare professionals use HbA1c as the main marker to monitor diabetic control. Patients with diabetes have regular review appointments to monitor their overall health and discuss their HbA1c target and results. The purpose of monitoring patients with diabetes is to improve patient outcomes. It is known that poor control is associated with poor clinical outcomes and also that reduced monitoring is linked to suboptimal diabetic control. Therefore, aiming for the correct monitoring frequency helps towards achieving the best control which can lead to the most favourable clinical outcomes. The inconvenience of attending for a blood test and follow-up appointment is a major factor affecting patient adherence to monitoring, locally approximately 50% of patients with diabetes have their HbA1c level measured either too soon or too late.
To address this issue and improve access to monitoring at the correct time interval we aim to produce a HbA1c home testing kit which can be posted back to the laboratory at the convenience of the patient. The kit will be developed based on feedback from patients with diabetes and will use a dried blood spot sample to produce HbA1c results comparable to the whole blood standard method.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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People with diabetes
Patients who have diabetes will be asked to use a home collection kit to collect a dried blood spot sample which will be compared to the HbA1C result.
Dried blood spot device
Patients will be asked to provide a dried blood spot sample
Health care professionals
Health care professionals who work with diabetic patients will be interviewed and asked about diabetes monitoring in the healthcare setting, comments on current laboratory service, patient engagement, comments on service improvement
Healthcare professional interviews
Health care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring
Interventions
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Dried blood spot device
Patients will be asked to provide a dried blood spot sample
Healthcare professional interviews
Health care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or over
* Venous blood sample for HbA1c collected within the two weeks prior to the clinic appointment
* Ability to provide fully informed consent
Exclusion Criteria
* Severe visual impairment which would leave the participant unable to complete the study procedures.
18 Years
90 Years
ALL
Yes
Sponsors
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University Hospitals of North Midlands NHS Trust
OTHER
Responsible Party
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Locations
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University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3242
Identifier Type: -
Identifier Source: org_study_id
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