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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
United Kingdom
University Hospitals of North Midlands NHS Trust
RECRUITING
Stoke-on-trent
Contact Information
Primary
Aviva Ogbolosingha
aviva.ogbolosingha@uhnm.nhs.uk
01782 675380
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
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.
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
Sponsors
Leads: University Hospitals of North Midlands NHS Trust

This content was sourced from clinicaltrials.gov