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

NCT06695325 | Recruiting DMC

• 2 other identifiers: Tameside003Roche
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus

Keywords

Home monitoring; HbA1c; Thyroid function; Lipids

Outcome Measures

Primary Outcomes (1)

• HbA1c

  to evaluate the accuracy and compare HbA1c measurement in-clinic testing by venous draw by health professionals vs home-based self-collected capillary blood sampling

  12 months

Secondary Outcomes (4)

• Lipids

  12 months

• Thyroid function

  12 months

• Participant acceptance

  12 months

• Health economics

  12 months

Study Arms (1)

Patients with type 1 and type 2 diabetes will be invited to take part in this study

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.

Diagnostic Test: HbA1c test

Interventions

HbA1c test DIAGNOSTIC_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.

Patients with type 1 and type 2 diabetes will be invited to take part in this study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified and approached during a routine diabetes clinic service run by Tameside and Glossop Integrated Care NHS Foundation Trust, based at Ashton Primary Care. This is a single site study. Consent, randomisation and a venous and a capillary self-collected sample will be collected at Tameside and Glossop Integrated Care NHS Foundation Trust. A second capillary sample will be self-collected by the participant in an outside the clinic setting and posted to the central laboratory. Participants will complete a questionnaire in the clinic as well as outside the clinic. The outside the clinic questionnaire will be posted back to the research team at Tameside General Hospital.

You may qualify if:

• Adult subjects aged 18 years and over at the time of signing the informed consent
• Ability to provide Informed consent
• Type I and II diabetic patient
• Ability to understand written and spoken English
• Ability to perform a blood draw at home

You may not qualify if:

• Aged less than 18 years of age
• Unable to provide informed consent
• Unable to perform a blood draw at home

Sponsors & Collaborators

• Roche Diagnostic Ltd.: collaborator
• Tameside General Hospital: lead

Study Sites (1)

Tameside and Glossop Integrated Care NHS Foundation Trust

Ashton-under-Lyne, Lancs, OL6 9RW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Edward Jude, MD FRCP

  Tameside and Glossop Integrated Care NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Jude, MD, FRCP

CONTACT

+441619224011; edward.jude@tgh.nhs.uk

Rebecca Roberts

CONTACT

+441619224451; rebecca.roberts@tgh.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 19, 2024
• Study Start: November 4, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 March 2025-15 December 2025
• Access Criteria: All data will be kept confidential and at the study site. No IPD will be made available to anyone outside of study site or not involved in the study. The laboratory that will be doing the blood sampling analysis and the funder who will be doing the statistics for the study will have access to non-identifiable data for the individual participants

Locations

GB (1)