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Active, Not Recruiting

NCT Number: NCT06038669

User Evaluation of a Home-collection Kit for People With Diabetes

Type 1 and Type 2 are the most common types of diabetes mellitus. Although the cause of Type 1 is different to Type 2, they can both lead to high blood glucose levels as the patient is unable to store and use sugar. The disease is an epidemic of the 21st century which is increasing, having a current prevalence of approximately 8%.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Type I or Type II diabetes
  • 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

  • Non-English speaking where translation of the study documents and procedures could limit fully informed consent
  • Severe visual impairment which would leave the participant unable to complete the study procedures.

Treatment and study plan

Dried Blood Spot device

Device

Patients will be asked to provide a dried blood spot sample

Healthcare professional interviews

Other

Health care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring

Primary outcomes

  1. DBS kit assay performance

    Time frame: 1 year, 3 months

    For the DBS-based home collection kit used by patients to be 'fit for purpose', it must achieve the following:

    Assay performance - correlation and bias. Correlation coefficient (r2 value) from linear regression plot should be >0.95 with a bias of less than 5%.

Secondary outcomes

  1. Participant questionnaires theme analysis

    Time frame: 1 year, 3 months

    Completed participant questionnaires will be collated and analysed for themes. We aim to determine whether participants deem the home-collection kit to be acceptable. The information gained will be used to design a full study.

  2. Interviews

    Time frame: 1 year, 3 months

    The health care professional interview transcripts will be recorded and analysed. The emerging themes will be taken into consideration when designing the full study.

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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