How leftover natural insulin affects health in people with diabetes
Studies how much insulin the body still makes in adults with insulin-treated diabetes.
Plain-language title generated from the registry record
Registry title: Benefits of Retained Insulin for Good Health
Key facts
- Where
- Bath, Bristol, Exeter, and Truro, United KingdomSee the 4 sites
Where in United Kingdom
- D1 Wolfson Centre Research and DevelopmentBath, United KingdomTaking people
- Clinical Research CentreBristol, United KingdomTaking people
- NIHR Exeter Clinical Research FacilityExeter, United KingdomTaking people
- Diabetes and Endocrine CentreTruro, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Royal Devon and Exeter NHS Foundation Trust
- Trial code
- NCT07828626
- Record updated
- 18 September 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Renal failure defined by eGFR <30mL/min/1.73 m².
ARM 1.