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Convenient Home Access for Routine Monitoring in Diabetes (Charm-D Study)

NCT06695325 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-12-26

No results posted yet for this study

Summary

Diabetes mellitus is a global problem and regular monitoring of blood sugar control is important to reduce the risk of complications secondary to poor sugar control. To assess control a simple blood test is undertaken called the HbA1c. This test gives an assessment of the person's sugar control over the previous 3 months and needs to be done regularly so that changes can be made to their treatment. The HbA1c test is routinely performed in clinic and blood taken from a vein in the arm using a needle and syringe. This involves travelling to the clinic, taking time off work and expense to the patient. Many times and for the above reasons patients do not attend the clinic and therefore do not have the HbA1c performed. Therefore the clinician will not know how their diabetes is doing and also they will not be able to make changes to the patient's diabetes treatment.

In this study we would like to assess home monitoring of diabetes by doing the HbA1c at home and sent to the laboratory. At the same time we will be checking the patient's blood cholesterol (lipids) levels and thyroid function (to assess if the thyroid gland which is in the neck, is making adequate hormones).

In the study the patient will first visit the clinic where blood will be taken from the arm as is done in routine clinical care. Then the patient will take blood himself/herself either from the finger (finger prick as is done when a patient checks their own blood glucose) or from the upper arm using a device that will be applied to the skin and blood will be collected in a small tube attached to the device. Half the patients will be asked to do a finger prick test and the other half will do the upper arm skin blood draw. The patient will be asked to fill a questionnaire, this is to understand their experience with the blood self-collection and how they classify it in comparison with the routine clinical care.

The patient will then go home with the similar device that they used in the clinic and will be asked to do the same blood draw at home as they did in the clinic (either finger prick or upper arm blood draw). They will need to do this within 2 days of the visit to the clinic. They will then post the sample to the central laboratory in the envelope provided.

At the same time the patient will be asked to fill out a questionnaire. This is to understand the ease or difficulty of the testing at home but will also help us analyse the cost effectiveness of doing the home blood collection.

Conditions

Interventions

DIAGNOSTIC_TEST

HbA1c test

Patients will be asked to have a HbA1c test in the clinic with a venous draw and then either fingerprick or upper arm draw. They will do the latter again at home.

Sponsors & Collaborators

  • Roche Diagnostic Ltd.

    collaborator INDUSTRY

  • Tameside General Hospital

    lead OTHER

Principal Investigators

  • Edward Jude, MD FRCP · Tameside and Glossop Integrated Care NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06695325 on ClinicalTrials.gov