How leftover natural insulin affects health in people with diabetes
Studies how much insulin the body still makes in adults with insulin-treated diabetes.
Key facts
- Who runs it
- Royal Devon and Exeter NHS Foundation Trust
- Where
- Bath, Bristol, Exeter, and Truro, United KingdomSee the 4 sites
- Trial code
- Registry title
- Benefits of Retained Insulin for Good Health
- Status
- Recruiting
- People taking part
- 700 people, planned
- Started
- 31 Oct 2025
- Expected to end
- 30 Jun 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Observational
- Record updated
- 18 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with insulin-treated diabetes (from the earlier StartRight study) and adults with type 1 diabetes who have a known C-peptide level or recent diagnosis with islet antibodies.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Insulin-treated diabetes (Arm 1). Type 1 diabetes (Arm 2): known C-peptide, or if not measured, within 7 years of diagnosis with at least 1 positive islet antibody.
- Earlier treatment
- Arm 1: must be on insulin treatment. No other prior treatment is asked for.
- Biomarker or test result
- Arm 2: known C-peptide level, or at least 1 positive islet antibody if C-peptide was not measured. If C-peptide is above 600pmol/L, previous positive islet autoantibodies are needed.
Main reasons for not taking part
- Kidney failure with eGFR below 30mL/min/1.73 m²
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Renal failure defined by eGFR <30mL/min/1.73 m²
Other criteria
- ARM 1
Where in United Kingdom
- D1 Wolfson Centre Research and DevelopmentBath, United KingdomContact: Diabetes and Lipids Research Team (Bath)Taking people
- Clinical Research CentreBristol, United KingdomContact: Diabetes Research Team (Bristol)Taking people
- NIHR Exeter Clinical Research FacilityExeter, United KingdomContact: BRIGHT Study Research TeamTaking people
- Diabetes and Endocrine CentreTruro, United KingdomContact: Diabetes and Renal Research Team (Truro)Taking people
About the trial
What the trial wants to find out
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
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.
The 2 groups in the trial
- Arm 1
Adults (aged \>= 18 years) diagnosed with diabetes for \>3 years, treatment with insulin, and previously taken part in the StartRight study with consent to re-contact.
Treatment: Observational
- Arm 2
Adults (aged \>= 18 years) diagnosed with type 1 diabetes. Known level of insulin secretion, measured using a C-peptide test after diabetes diagnosis. Participants will have had C-peptide measured as part of a previous research study or as part of their diabetes clinical care. 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.
Treatment: Observational
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- How leftover natural insulin affects health in people with diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 September 2026