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

NCT06038669 | Active Not Recruiting

• 1 other identifier: 3242
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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%.

  1 year, 3 months

Secondary Outcomes (2)

• Participant questionnaires theme analysis

  1 year, 3 months

• Interviews

  1 year, 3 months

Study Arms (2)

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.

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

Other: Healthcare professional interviews

Interventions

Dried blood spot device DEVICE

Patients will be asked to provide a dried blood spot sample

People with diabetes

Healthcare professional interviews OTHER

Health care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring

Health care professionals

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: February 20, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)