Clinical trial NCT06038669: User Evaluation of a Home-collection Kit for People With Diabetes
Official title: User Evaluation of a Home-collection Kit for People With Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: DBS kit assay performance
timeFrame: 1 year, 3 months
Secondary outcomes:
measure: Participant questionnaires theme analysis
timeFrame: 1 year, 3 months
measure: Interviews
timeFrame: 1 year, 3 months
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
References: