NCT06038669

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: University Hospitals of North Midlands NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Dried blood spot device	Patients will be asked to provide a dried blood spot sample
OTHER	Healthcare professional interviews	Health care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring

Timeline

• Start date: 2024-02-20
• Primary completion: 2025-03-31
• Completion: 2026-12-31
• First posted: 2023-09-15
• Last updated: 2026-03-27

Locations

1 site across 1 country: United Kingdom