User Evaluation of a Home-collection Kit for People With Diabetes - Trial NCT06038669

Timeline & Enrollment

Primary Outcome

DBS kit assay performance

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.

ICD-10 Classifications