RecruitingNCT07828626

Benefits of Retained Insulin for Good Health

Understanding the Impact of Endogenous Insulin Secretion on Clinical Outcomes in Type 1 Diabetes and the Optimal Approach to C-peptide Measurement for Outcome Prediction


Sponsor

Royal Devon and Exeter NHS Foundation Trust

Enrollment

700 participants

Start Date

Oct 31, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this research is to understand the impact of retained endogenous insulin (as measured by C-peptide) on quality of life and related outcomes in people living with insulin treated diabetes, and, in those living with type 1 diabetes, to determine the pragmatic and non-pragmatic C-peptide measures which have the strongest association with clinical benefit (including repeated home samples and derived measures of beta cell function). The investigators will do this in two ways: Firstly, the investigators will extend a large existing prospective study of new adult onset diabetes (Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes (StartRight)) https://clinicaltrials.gov/ct2/show/NCT03737799) which has followed 1800 participants for median 4 years from diabetes diagnosis. Participants with insulin treated diabetes will be invited to take part in a further research visit remotely or face to face. The investigators will assess the longitudinal relationship between C-peptide and the available quality of life, mental health status and healthcare utilisation measures over up to 9 years from diabetes diagnosis and assess additional measures in cross sectional analysis. In the second part of this research, the investigators will utilise cohorts of over 2500 participants with type 1 diabetes, measured C-peptide and consent to recontact to recruit 200 participants with a range of C-peptide. Eligible participants with C-peptide measured in clinical care may also be invited to take part. The investigators will undertake detailed assessment of complex and pragmatic measures of C-peptide and beta cell function and compare performance in predicting glycaemic outcomes (using data from continuous glucose monitors) and (where relevant) patient reported outcomes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Observational for people with diabetes, diabetes (dm), and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERObservational

Observational


Locations(4)

Diabetes and Endocrine Centre

Truro, Cornwall, United Kingdom

NIHR Exeter Clinical Research Facility

Exeter, Devon, United Kingdom

D1 Wolfson Centre Research and Development

Bath, United Kingdom

Clinical Research Centre

Bristol, United Kingdom

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NCT07828626


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