Assessing Remote Confirmation of Type 1 Diabetes

The aim of this research is to assess the practicalities and potential benefits of collecting home finger prick samples from all patients within a hospital type 1 diabetes service to test how much insulin each patient is producing. To do this we will send detailed study information, sample collection kits and reply-paid return packs to 1500 randomly selected patients, treated as type 1 diabetes, in a hospital clinic (3000 patients in the whole clinic). We will ask participants to consent to take part (either online or by completing a paper consent form returned with their pack) before collecting a finger prick blood sample. We will ask participants to collect the sample between 1 and 5 hours after a meal and to check and record their blood glucose level at the same time. Participants will then return the sample and glucose result, using the pre-paid pack provided, to the hospital clinic laboratory for a test called C-peptide (a measure of how much of their own insulin they are producing). The sample collection process should take no longer than 10 minutes. We will record the percentage of patients returning samples within 4 weeks of initial contact and determine the number of cases with high C-peptide suggestive of non-type 1 diabetes. If this study shows remote C-peptide testing is a practical and acceptable to patients, it could allow this remote service to be offered to all type 1 diabetes clinics in every hospital in the United Kingdom. An estimated 350,000 people in the United Kingdom have type 1 diabetes. Reclassifying an estimated 1 in 15 people would mean approximately 23,000 people nationally could benefit from being identified as potentially able to stop insulin treatment.

NCT Number	NCT06821360
Lead Sponsor	Royal Devon and Exeter NHS Foundation Trust Collaborators: NIHR Exeter Clinical Research Facility, National Institute for Health Research, United Kingdom
Conditions	Diabetes, Type 1 Diabetes (T1D)
Enrollment	1,000 participants
Start Date	2024-12-03
Primary Completion	2025-09 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-02-12