NCT07828626Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 11 Aug 2026
- Start date
- 31 Oct 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07828626
What you commit to
- Study type: Observational
- Planned participants: 700
- From 31 Oct 2025 to the primary completion date, 30 Apr 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- \- Renal failure defined by eGFR \<30mL/min/1.73 m²
Who the study is looking for
- Previously recruited to the StartRight study (NCT03737799) with consent to be contacted for further research
- Clinical diagnosis of diabetes \& Insulin treated
- Able and willing to provide informed consent/assent.
- Aged 18 years or older.
- ARM 2
- Clinical diagnosis of Type 1 diabetes
- Known C-peptide, measured as part of previous research or as part of diabetes clinical care OR Where C-peptide is not measured, participant must be within 7 years of diagnosis and have at least 1 positive islet antibody, measured at any time since diabetes diagnosis.
- Where measured C-peptide is \>600pmol/L, previous positive islet autoantibodies.
- Able and willing to provide informed consent
- Aged 18 years or older
Criteria the registry did not label
- ARM 1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| D1 Wolfson Centre Research and Development Coordinator of this site? Confirm its status | Bath | United Kingdom | Recruiting |
| Clinical Research Centre Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| NIHR Exeter Clinical Research Facility Coordinator of this site? Confirm its status | Exeter | United Kingdom | Recruiting |
| Diabetes and Endocrine Centre Coordinator of this site? Confirm its status | Truro | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.