DiabetesNCT06038669
User Evaluation of a Home-collection Kit for People With Diabetes
An observational study of Diabetes, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Dried blood spot device and Healthcare professional interviews
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic patients (type I and II) aged over 18 years old. Healthcare professionals aged 18 or over who work with patients with diabetes.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent
About this study
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.
Read more
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.
- Conditions
- Diabetes
- Being tested
- Dried blood spot device, Healthcare professional interviews
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried blood spot deviceDevice
Patients will be asked to provide a dried blood spot sample
Healthcare professional interviewsOther
Health care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dried blood spot device | |
| 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 Receives: Other: Healthcare professional interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
DBS kit assay performance
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%.
Measured: 1 year, 3 months
Secondary outcomes (2)
Participant questionnaires theme analysis
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.
Measured: 1 year, 3 months
Interviews
The health care professional interview transcripts will be recorded and analysed. The emerging themes will be taken into consideration when designing the full study.
Measured: 1 year, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start20 Feb 2024
- Primary completion31 Mar 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038669
- Sponsor's protocol ID
- 3242
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Evaluation of a Home-collection Kit for People With Diabetes
- ClinicalTrials.gov ID
- NCT06038669
- Acronym / sponsor ID
- 3242
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with diabetes | – | Device: Dried blood spot devicePatients 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. |
| Health care professionals | – | Other: Healthcare professional interviewsHealth 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients (type I and II) aged over 18 years old. Healthcare professionals aged 18 or over who work with patients with diabetes.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Dried blood spot devicePatients will be asked to provide a dried blood spot sample | Device | People with diabetes |
| Healthcare professional interviewsHealth care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring | Other | Health care professionals |
Primary outcome
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%.
2 secondary outcomes
Participant questionnaires theme analysis
Time frame: 1 year, 3 months
Interviews
Time frame: 1 year, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by University Hospitals of North Midlands NHS Trust at 1 site 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 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
DBS kit assay performance (time frame: 1 year, 3 months). 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 27 Mar 2026.