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Search / Trial NCT04682457

Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.

Launched by ROYAL DEVON AND EXETER NHS FOUNDATION TRUST · Dec 22, 2020

Trial Information

Current as of August 02, 2025

Completed

Keywords

ClinConnect Summary

The study aims to evaluate progression of type 1 diabetes. Primary analysis will be conducted on those with \>=1 diabetes autoantibody positive (GAD, IA2 ZNT8). Sensitivity analysis will be performed by repeating all analysis defining T1D as a) double antibody positivity and b) single antibody positivity combined with a high genetic risk score for T1D (T1DGRS\>5th centile of a control population).

Further aims will be to evaluate the utility of dried blood spot testing to detect change in C-peptide and the utility of home test results as a marker of hypoglycaemia and glucose variability.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults with a clinical diagnosis of Type 1 diabetes within the previous 100 days.
  • Aged \>30 at the time of Type 1 diabetes diagnosis OR (additional early onset Type 1 diabetes cohort) aged ≥18 and ≤30 at the time of Type 1 diabetes diagnosis.
  • Insulin treated at the time of recruitment
  • Able and willing to provide informed consent.
  • Exclusion criteria
  • Pregnancy
  • Known monogenic diabetes
  • Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).

About Royal Devon And Exeter Nhs Foundation Trust

The Royal Devon and Exeter NHS Foundation Trust is a leading healthcare organization dedicated to delivering high-quality patient care and advancing medical research. Located in Exeter, the Trust is committed to innovation and excellence in clinical trials, facilitating studies that aim to improve health outcomes and enhance treatment options across various medical disciplines. With a strong emphasis on collaboration, the Trust partners with researchers, healthcare professionals, and patients to foster a research environment that prioritizes safety, ethical standards, and scientific integrity. Through its robust infrastructure and expertise, the Royal Devon and Exeter NHS Foundation Trust plays a vital role in the advancement of evidence-based medicine and the translation of research findings into clinical practice.

Locations

Exeter, Devon, United Kingdom

Patients applied

0 patients applied

Trial Officials

Angus Jones, MBBS MRCP

Study Director

NIHR Exeter Clinical Research Facility

Nicholas Thomas, MRCP

Principal Investigator

NIHR Exeter Clinical Research Facility

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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