Assessing Remote Confirmation of Type 1 Diabetes

NCT06821360 | Enrolling By Invitation

• 2 other identifiers: 3388642410662
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Type 1 Diabetes (T1D)

Keywords

Diabetes diagnosis. Insulin levels. Remote testing. C-peptide. Home finger-prick samples.

Outcome Measures

Primary Outcomes (1)

• Proportion of samples returned

  The number of completed samples returned within four weeks of sample pack mailout.

  Within 4 weeks of initial contact

Study Arms (1)

Main Cohort

Adults treated as Type 1 diabetes (T1D) and under the clinical care of the specialist diabetes team(s) at the Royal Devon University Healthcare NHS Foundation Trust. Diabetes duration \>3 years at the time of study participation. Aged \> 18 at the time of study participation.

Diagnostic Test: C-peptide test

Interventions

C-peptide test DIAGNOSTIC_TEST

Participants collect a single home finger-prick sample and post to the clinical laboratory for C-peptide analysis (a measure of endogenous insulin production).

Main Cohort

Eligibility Criteria

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

Study Population

Patients with a Type 1 diabetes follow up code OR rapid progression to insulin (within 3 years of diagnosis) to capture miscoded cases. Under the clinical care of the diabetes team(s) at the Royal Devon University Healthcare NHS Foundation Trust

You may qualify if:

• Patients with a Type 1 diabetes follow up code OR rapid progression to insulin (within 3 years of diagnosis) to capture miscoded cases.
• Under the clinical care of the diabetes team(s) at the Royal Devon University Healthcare NHS Foundation Trust
• Duration of diabetes \>3 years
• Aged 18 years or older.

You may not qualify if:

• Patients considered by their clinical care team to be unsuitable/inappropriate to be invited to take part in this research (e.g. severe sight impairment, reduced capacity to consent)

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• NIHR Exeter Clinical Research Facility: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

NIHR Exeter Clinical Research Facility

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicholas Thomas, PhD MRCP

  University of Exeter and Royal Devon University Healthcare NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 12, 2025
• Study Start: December 3, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)