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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Summary

The study aims is to find out if people with type 1 diabetes diagnosed in later life (after age 30) have the same rapid loss of insulin secretion (measured using C-peptide) that occurs in younger adults with type 1 diabetes. The investigators will recruit 135 participants aged over 30 years with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. The investigators will also recruit a comparison group of 61 participants aged 18-30 with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. C-peptide will be measured during mixed meal tolerance tests (MMTT) performed at baseline, 6 months and a year. This study also aims to test a new more practical way of monitoring insulin secretion at home using a finger prick 'blood spot' rather than time consuming tests in a hospital. Finger-prick C-peptide samples will be collected after the MMTT and by the participants at home throughout the year.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04682457
Study type Observational
Source Royal Devon and Exeter NHS Foundation Trust
Contact
Status Completed
Phase
Start date November 1, 2019
Completion date December 31, 2023
View Details
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