Diabetes (Insulin-requiring, Type 1 or Type 2)BRIGHTNCT07828626
Benefits of Retained Insulin for Good Health
An observational study of Diabetes (Insulin-requiring, Type 1 or Type 2) and Diabetes, run by Royal Devon and Exeter NHS Foundation Trust at 4 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes, Diabetes (DM)
- What is being tested?
- Observational
- How many people
- 700 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 31 Oct 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 10Show fewer
- 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 join
- Renal failure defined by eGFR <30mL/min/1.73 m²
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites, 4 recruiting
- Recruiting
D1 Wolfson Centre Research and Development
Bath, BA1 3NG
Diabetes and Lipids Research Team (Bath), +44 1225821304, ruh-tr.DiabetesAndLipidsResearch@nhs.net
Rachel Mathias
- Recruiting
Clinical Research Centre
Bristol, BS10 5NB
Diabetes Research Team (Bristol), +44 1174148125, nbn-tr.nbtdiabetesresearch@nhs.net
Georgina Russell
- Recruiting
NIHR Exeter Clinical Research Facility
Exeter, Devon, EX2 5DW
BRIGHT Study Research Team, +44 1392408181, rduh.brightstudy@nhs.net
Angus Jones
- Recruiting
Diabetes and Endocrine Centre
Truro, Cornwall, TR1 3LJ
Diabetes and Renal Research Team (Truro), +44 1872254655, rcht.diabetesresearch@nhs.net
Duncan Browne
About this study
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
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.
Read the detailed description
The purpose of this study is to understand the possible benefits of restoring insulin secretion in people living with diabetes, and to understand how insulin secretion can be best measured in people living with diabetes.
Most people living with type 1 diabetes stop making their own insulin, this means that insulin injections are needed to survive. It also means their blood glucose is variable, meaning it is very difficult to control blood glucose levels. This is in contrast to type 2 diabetes, where most people keep making their own insulin, and loss of insulin production is uncommon.
Previous research has shown that some people with type 1 diabetes keep making some of their own insulin, and this can be very helpful for their blood glucose control. However, there is limited information on long term benefits of making insulin, and other possible benefits, such as on wellbeing, have not been studied. It is important that the full benefits of making insulin are known as new treatments have been developed to preserve insulin secretion in type 1 diabetes, and/or to restore insulin secretion. These treatments are expensive and can have side effects, and have been studied only in small studies for a short amount of time. It is important to fully understand the likely long-term benefits of preserving or restoring insulin secretion to know whether healthcare providers like the NHS should fund these treatments.
At present research studies that are testing new treatments to preserve or restore a person's insulin production need to frequently test insulin secretion, using a test called a mixed meal tolerance test that needs to be undertaken in a hospital setting and takes at least 2.5 hours. This makes these studies difficult to take part in, and expensive to run. Insulin production can now be measured at home, on a finger-prick test, but more information is needed on the best way to do the home test for these kinds of studies.
This research has two parts. In the first part of this research the investigators will measure insulin secretion (using a test called C-peptide) in 500 people with insulin treated diabetes who have already taken part in a large recent study that measured their insulin secretion, and other important measures such as their quality of life and use of healthcare services, every year for up to 4 years after diabetes diagnosis. There will be assessment of participants' quality of life and other measures related to diabetes. The investigators will use this information, and the information already collected in the study, to understand the effects of retaining or loosing insulin production over up to 9 years from diabetes diagnosis, and compare whether this differs in type 1 and 2 diabetes.
In the second part of this research the investigators will recruit 200 participants with type 1 diabetes who have had their insulin secretion measured in part one of this research, in other research or in clinical care. Information from this previous testing will be used to ensure participants are recruited with a range of insulin production. Participants will attend a research facility for assessment of their insulin production over 2 hours after a liquid meal similar to a milkshake. Participants will then undertake this test at home, using finger-prick samples after the same liquid meal, and after 3 of their own normal meals. Participants will also monitor their glucose over 2 weeks using a device called a continuous glucose monitor. This information will be used to understand if home measures are as accurate as the test in the research facility, and work as well in predicting a person's risk of low glucose (hypoglycaemia) and how variable their glucose is.
The end result of this research will be important information to inform the design of studies of new treatments to preserve or restore insulin secretion for people living with diabetes and understand the likely long-term benefits of these treatments.
- Conditions
- Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes, Diabetes (DM), Type 1 Diabetes (T1D)
- Being tested
- Observational
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90-minutes post baseline
Secondary outcomes (5)
Questionnaire assessed hypoglycaemia and hypoglycaemia unawareness (Arm 1 & Arm 2)
Results from analysis of data from Modified Clarke/Edinburgh Hypoglycaemia History questionnaire
Measured: Symptoms experienced during 4 weeks prior to study enrolment
Questionnaire assessed emotional burden (Arm 1 & Arm 2)
Results from analysis of data from Diabetes Distress Scale questionnaire
Measured: Symptoms experienced during 4 weeks prior to study enrolment
Questionnaire assessed quality of life/wellbeing (Arm 1 & Arm 2)
Results from analysis of data from Veterans RAND 12-Item Health Survey (VR-12) questionnaire
Measured: 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)
Data collected during current study visit combined with data from previous study visit.
Measured: Up to 3 years prior to study enrolment
Continuous glucose monitor measured glucose variability and hypoglycaemia (Arm 2)
Analysis for Arm 2 will compare the relationship of different C-peptide measures to glucose variability (assessed as Standard Deviation glucose) and hypoglycaemia (assessed as % time glucose below 3mmol/L), derived from 14 days of continuous interstitial glucose monitoring
Measured: 14 days during study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start31 Oct 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (Insulin-requiring, Type 1 or Type 2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter, University of Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828626
- Sponsor's protocol ID
- 2507771
- Other IDs
- 2-SRA-2025-1637-S-B
- Acronym
- BRIGHT
- Status last verified
- Feb 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07828626
- Acronym / sponsor ID
- BRIGHT / 2507771
- Conditions
- Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes, Diabetes (DM), Type 1 Diabetes (T1D)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter, University of Birmingham
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to understand the possible benefits of restoring insulin secretion in people living with diabetes, and to understand how insulin secretion can be best measured in people living with diabetes.
Most people living with type 1 diabetes stop making their own insulin, this means that insulin injections are needed to survive. It also means their blood glucose is variable, meaning it is very difficult to control blood glucose levels. This is in contrast to type 2 diabetes, where most people keep making their own insulin, and loss of insulin production is uncommon.
Previous research has shown that some people with type 1 diabetes keep making some of their own insulin, and this can be very helpful for their blood glucose control. However, there is limited information on long term benefits of making insulin, and other possible benefits, such as on wellbeing, have not been studied. It is important that the full benefits of making insulin are known as new treatments have been developed to preserve insulin secretion in type 1 diabetes, and/or to restore insulin secretion. These treatments are expensive and can have side effects, and have been studied only in small studies for a short amount of time. It is important to fully understand the likely long-term benefits of preserving or restoring insulin secretion to know whether healthcare providers like the NHS should fund these treatments.
At present research studies that are testing new treatments to preserve or restore a person's insulin production need to frequently test insulin secretion, using a test called a mixed meal tolerance test that needs to be undertaken in a hospital setting and takes at least 2.5 hours. This makes these studies difficult to take part in, and expensive to run. Insulin production can now be measured at home, on a finger-prick test, but more information is needed on the best way to do the home test for these kinds of studies.
This research has two parts. In the first part of this research the investigators will measure insulin secretion (using a test called C-peptide) in 500 people with insulin treated diabetes who have already taken part in a large recent study that measured their insulin secretion, and other important measures such as their quality of life and use of healthcare services, every year for up to 4 years after diabetes diagnosis. There will be assessment of participants' quality of life and other measures related to diabetes. The investigators will use this information, and the information already collected in the study, to understand the effects of retaining or loosing insulin production over up to 9 years from diabetes diagnosis, and compare whether this differs in type 1 and 2 diabetes.
In the second part of this research the investigators will recruit 200 participants with type 1 diabetes who have had their insulin secretion measured in part one of this research, in other research or in clinical care. Information from this previous testing will be used to ensure participants are recruited with a range of insulin production. Participants will attend a research facility for assessment of their insulin production over 2 hours after a liquid meal similar to a milkshake. Participants will then undertake this test at home, using finger-prick samples after the same liquid meal, and after 3 of their own normal meals. Participants will also monitor their glucose over 2 weeks using a device called a continuous glucose monitor. This information will be used to understand if home measures are as accurate as the test in the research facility, and work as well in predicting a person's risk of low glucose (hypoglycaemia) and how variable their glucose is.
The end result of this research will be important information to inform the design of studies of new treatments to preserve or restore insulin secretion for people living with diabetes and understand the likely long-term benefits of these treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: ObservationalAdults (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. |
| Arm 2 | – | Other: ObservationalAdults (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Renal failure defined by eGFR <30mL/min/1.73 m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Arm 1, Arm 2 |
Primary outcome
Capillary C-peptide measured 1-5 hours after a meal containing carbohydrates (Arm 1)
Time frame: 1 day during study participation
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.
Plasma and capillary C-peptide (Arm 2)
Time frame: 90-minutes post baseline
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.
5 secondary outcomes
Questionnaire assessed hypoglycaemia and hypoglycaemia unawareness (Arm 1 & Arm 2)
Time frame: Symptoms experienced during 4 weeks prior to study enrolment
Questionnaire assessed emotional burden (Arm 1 & Arm 2)
Time frame: Symptoms experienced during 4 weeks prior to study enrolment
Questionnaire assessed quality of life/wellbeing (Arm 1 & Arm 2)
Time frame: 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)
Time frame: Up to 3 years prior to study enrolment
Continuous glucose monitor measured glucose variability and hypoglycaemia (Arm 2)
Time frame: 14 days during study participation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes (Insulin-requiring, Type 1 or Type 2) and Diabetes, run by Royal Devon and Exeter NHS Foundation Trust at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BRIGHT Study Research Team (+44 1392408181, rduh.brightstudy@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary C-peptide measured 1-5 hours after a meal containing carbohydrates (Arm 1) (time frame: 1 day during study participation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.