Benefits of Retained Insulin for Good Health

NCT07828626 | Recruiting

• 2 other identifiers: 25077712-SRA-2025-1637-S-B
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Diabetes; Type 1 Diabetes (T1D); Diabetes (DM); Diabetes (Insulin-requiring, Type 1 or Type 2)

Outcome Measures

Primary Outcomes (2)

• Capillary C-peptide measured 1-5 hours after a meal containing carbohydrates (Arm 1)

  Analysis of Arm 1 will assess the relationship between home post-meal C-peptide (measured serially from within 12 months of diagnosis up to 10 years post-diagnosis, through extension of an existing study), and the secondary outcomes listed below. This will be assessed as longitudinal change over time (Arm 1 cohort) and cross-sectionally using the most recent visit data from the combined Arm 1 and Arm 2 cohorts.

  1 day during study participation

• Plasma and capillary C-peptide (Arm 2)

  Primary analysis for Arm 2 will assess the relationship between home capillary C-peptide measurements (post-meal, assessed individually \& as the average of up to three measurements, and 90-minute post-mixed meal tolerance test) and 90-minute plasma C-peptide measured during a mixed meal tolerance test conducted at a research centre. Secondary analysis will compare the relationship between C-peptide measures and the continuous glucose monitoring secondary outcome listed below.

  90-minutes post baseline

Secondary Outcomes (5)

• Questionnaire assessed hypoglycaemia and hypoglycaemia unawareness (Arm 1 & Arm 2)

  Symptoms experienced during 4 weeks prior to study enrolment

• Questionnaire assessed emotional burden (Arm 1 & Arm 2)

  Symptoms experienced during 4 weeks prior to study enrolment

• Questionnaire assessed quality of life/wellbeing (Arm 1 & Arm 2)

  Symptoms experienced during 4 weeks prior to study enrolment

• Changes/updates to diabetes treatment, complications and healthcare utilisation for relevant medical conditions since previous study visit (Arm 1)

  Up to 3 years prior to study enrolment

• Continuous glucose monitor measured glucose variability and hypoglycaemia (Arm 2)

  14 days during study participation

Study Arms (2)

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.

Other: 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.

Other: Observational

Interventions

Observational OTHER

Observational

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ARM 1: Participants who have previously taken part in the StartRight study (NCT03737799) with consent to re-contact for future research (from sites across the United Kingdom (UK)). ARM 2: Participants who have previously taken part in the StartRight study or other diabetes research cohorts, as well as patients referred by their clinician or self-referred (across the UK).

You may qualify if:

• 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

You may not qualify if:

• \- Renal failure defined by eGFR \<30mL/min/1.73 m²

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University of Exeter: collaborator
• University of Birmingham: collaborator

Study Sites (4)

Diabetes and Endocrine Centre

Truro, Cornwall, TR1 3LJ, United Kingdom

RECRUITING

NIHR Exeter Clinical Research Facility

Exeter, Devon, EX2 5DW, United Kingdom

RECRUITING

D1 Wolfson Centre Research and Development

Bath, BA1 3NG, United Kingdom

RECRUITING

Clinical Research Centre

Bristol, BS10 5NB, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human biological blood samples

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

BRIGHT Study Research Team

CONTACT

+44 1392408181; rduh.brightstudy@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: September 18, 2026
• Study Start: October 31, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-02

Locations

GB (4)