Diabetes MellitusStartRightNCT03737799
StartRight: Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes
An observational study of Diabetes Mellitus, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to achieve more accurate early classification of diabetes and identification of which patients will rapidly require insulin treatment. The investigators will recruit 1200 participants who have been diagnosed with diabetes in the last year and were aged between 18 and 50 years at the time of diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 1,815 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2016to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Recently diagnosed diabetes patients in primary care, secondary care or community.
Who may be able to join
- Adults diagnosed with diabetes within the previous 12 months.
- Aged ≥18 and ≤50 at the time of diabetes diagnosis* or (additional late onset diabetes cohort) aged >50 at the time of diabetes diagnosis.
- Able and willing to provide informed consent
Who cannot join
- Gestational diabetes.
- Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to achieve more accurate early classification of diabetes and identification of which patients will rapidly require insulin treatment. The investigators will recruit 1200 participants who have been diagnosed with diabetes in the last year and were aged between 18 and 50 years at the time of diagnosis. The investigators will recruit an additional cohort of 800 participants diagnosed after age 50. The investigators will record clinical features and biomarkers that may help us to determine diabetes type at diagnosis and follow participants for 3 years to assess the development of severe insulin deficiency (measured using C-peptide) and insulin requirement. The investigators will assess utility of clinical features and additional biomarkers in identifying patients with rapid progression to insulin requirement. Findings will be integrated into a freely available clinical prediction models to assist classification of diabetes at diagnosis.
Read the detailed description
The study is a prospective observational study which will assess the relationship between clinical features and biomarkers at diabetes diagnosis and type of diabetes defined by endogenous insulin secretion at 3 years diabetes duration.
The investigators will recruit a prospective cohort of 1200 adults that have been diagnosed with diabetes within the previous 1 year and aged between 18 and 50 at the time of diagnosis. The investigators will also recruit an additional cohort of 800 participants diagnosed with diabetes in the last year aged >50 at diabetes diagnosis, who will be stratified by insulin treatment (insulin treated n=400).
On recruitment into the study, non-fasting (within 1-5 hours of a meal) blood sample will be collected for baseline analysis biomarker assessment (serum C-peptide, routine biochemistry, Islet autoantibodies (GAD, IA2, ZnT8)) and biobanking. Clinical features will be recorded, including weight, height, waist/hip ratio \& blood pressure. Participants will be asked to provide a home post-meal urine sample for Urinary C-Peptide Creatinine Ratio (UCPCR). At 1 year and 2 years post recruitment, participants will be contacted by telephone, email or in person to record concurrent treatment, hypoglycaemia and health service utilisation. Participants will be asked to collect a home post-meal urine sample for Urinary C-Peptide /Creatinine Ratio (UCPCR). HbA1c results will be obtained from participants GP practice or laboratory records.
At the end of the study, 3 years post recruitment, a non-fasting blood sample will be collected for serum C-peptide, routine biochemistry and stored for future biomarker analysis. Weight change, blood pressure, concurrent treatment, hypoglycaemia and health service utilisation data will be also be recorded.
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, C-peptide, Insulin, Classification
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Age 18-50 at diagnosis | Diagnosed with diabetes within the previous 1 year. Aged between 18 and 50 years at the time of diabetes diagnosis | |
| Group 2 Late Onset (insulin) | Diagnosed with diabetes within the previous 1 year. Aged >50 at the time of diabetes diagnosis and treated with insulin therapy | |
| Group 3 Late Onset (no insulin) | Diagnosed with diabetes within the previous 1 year. Aged >50 at the time of diabetes diagnosis and treated without insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes type defined by insulin requirement at 3 years
Type 1 diabetes = Progression to insulin treatment and severe insulin deficiency (post meal plasma C-peptide <600pmol/L) at 3 years.
Type 2 diabetes = Lack of requirement for insulin at 3 years (HbA1c <90mmol/mol without insulin treatment or post meal C-peptide ≥ 600pmol/L if insulin treated).
Measured: 3 years
Secondary outcomes (8)
Stimulated plasma C-peptide <200pmol/L at 3 years ('absolute insulin deficiency')
C-peptide <200pmol/L at 3 years = absolute insulin deficiency
Measured: 3 years
C-peptide rate of change (UCPCR and plasma)
The rate of change of UCPCR and plasma C-peptide
Measured: 3 years
Weight change (baseline to 3 years)
Assessment of weight change from baseline to 3 year visit
Measured: 3 years
HbA1c (mean and at 3 years)
Mean HbA1c for all visits and result at 3 years
Measured: 3 years
Self-reported hypoglycaemia & hypoglycaemic awareness (Modified Clark and Gold)
Results from Hypoglycaemia questionnaire
Measured: 3 years
Resilience (CD-RISC questionnaires)
Results from analysis of data from CD-RISC questionnaire
Measured: 3 years
Ketoacidosis (self-reported and confirmed from medical notes)
Self reported Ketoacidosis and confirmation in medical notes
Measured: 3 years
Wellbeing (SF12 questionnaire)
Results from analysis of data from SF12 questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Aug 2016
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 1,815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Diabetes UK, University of Exeter
- Responsible party
- Sponsor
- Investigators
- Angus G Jones, MBBS MRCP, Principal investigator, Royal Devon & Exeter NHS Foundation Trust & University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737799
- Sponsor's protocol ID
- CRF243
- Other IDs
- 203567, CS-2015-15-018, 17/0005624
- Acronym
- StartRight
- Status last verified
- Jun 2024
- First submitted
- 8 Oct 2018
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thomas NJ, Lynam AL, Hill AV, Weedon MN, Shields BM, Oram RA, McDonald TJ, Hattersley AT, Jones AG. Type 1 diabetes defined by severe insulin deficiency occurs after 30 years of age and is commonly treated as type 2 diabetes. Diabetologia. 2019 Jul;62(7):1167-1172. doi: 10.1007/s00125-019-4863-8. Epub 2019 Apr 10.
PubMed 30969375Eason RJ, Thomas NJ, Hill AV, Knight BA, Carr A, Hattersley AT, McDonald TJ, Shields BM, Jones AG; StartRight Study Group. Routine Islet Autoantibody Testing in Clinically Diagnosed Adult-Onset Type 1 Diabetes Can Help Identify Misclassification and the Possibility of Successful Insulin Cessation. Diabetes Care. 2022 Dec 1;45(12):2844-2851. doi: 10.2337/dc22-0623.
PubMed 36205650Thomas NJ, Hill AV, Dayan CM, Oram RA, McDonald TJ, Shields BM, Jones AG; StartRight Study Group. Age of Diagnosis Does Not Alter the Presentation or Progression of Robustly Defined Adult-Onset Type 1 Diabetes. Diabetes Care. 2023 Jun 1;46(6):1156-1163. doi: 10.2337/dc22-2159.
PubMed 36802355
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StartRight: Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes
- ClinicalTrials.gov ID
- NCT03737799
- Acronym / sponsor ID
- StartRight / CRF243
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, C-peptide, Insulin, Classification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,815 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Diabetes UK, University of Exeter
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Nov 2018 (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.
This study aims to achieve more accurate early classification of diabetes and identification of which patients will rapidly require insulin treatment. The investigators will recruit 1200 participants who have been diagnosed with diabetes in the last year and were aged between 18 and 50 years at the time of diagnosis. The investigators will recruit an additional cohort of 800 participants diagnosed after age 50. The investigators will record clinical features and biomarkers that may help us to determine diabetes type at diagnosis and follow participants for 3 years to assess the development of severe insulin deficiency (measured using C-peptide) and insulin requirement. The investigators will assess utility of clinical features and additional biomarkers in identifying patients with rapid progression to insulin requirement. Findings will be integrated into a freely available clinical prediction models to assist classification of diabetes at diagnosis.
Detailed description
The study is a prospective observational study which will assess the relationship between clinical features and biomarkers at diabetes diagnosis and type of diabetes defined by endogenous insulin secretion at 3 years diabetes duration.
The investigators will recruit a prospective cohort of 1200 adults that have been diagnosed with diabetes within the previous 1 year and aged between 18 and 50 at the time of diagnosis. The investigators will also recruit an additional cohort of 800 participants diagnosed with diabetes in the last year aged >50 at diabetes diagnosis, who will be stratified by insulin treatment (insulin treated n=400).
On recruitment into the study, non-fasting (within 1-5 hours of a meal) blood sample will be collected for baseline analysis biomarker assessment (serum C-peptide, routine biochemistry, Islet autoantibodies (GAD, IA2, ZnT8)) and biobanking. Clinical features will be recorded, including weight, height, waist/hip ratio \& blood pressure. Participants will be asked to provide a home post-meal urine sample for Urinary C-Peptide Creatinine Ratio (UCPCR). At 1 year and 2 years post recruitment, participants will be contacted by telephone, email or in person to record concurrent treatment, hypoglycaemia and health service utilisation. Participants will be asked to collect a home post-meal urine sample for Urinary C-Peptide /Creatinine Ratio (UCPCR). HbA1c results will be obtained from participants GP practice or laboratory records.
At the end of the study, 3 years post recruitment, a non-fasting blood sample will be collected for serum C-peptide, routine biochemistry and stored for future biomarker analysis. Weight change, blood pressure, concurrent treatment, hypoglycaemia and health service utilisation data will be also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Age 18-50 at diagnosis | – | –Diagnosed with diabetes within the previous 1 year. Aged between 18 and 50 years at the time of diabetes diagnosis |
| Group 2 Late Onset (insulin) | – | –Diagnosed with diabetes within the previous 1 year. Aged >50 at the time of diabetes diagnosis and treated with insulin therapy |
| Group 3 Late Onset (no insulin) | – | –Diagnosed with diabetes within the previous 1 year. Aged >50 at the time of diabetes diagnosis and treated without insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recently diagnosed diabetes patients in primary care, secondary care or community.
Key inclusion criteria (3 listed)
- Adults diagnosed with diabetes within the previous 12 months.
- Aged ≥18 and ≤50 at the time of diabetes diagnosis* or (additional late onset diabetes cohort) aged >50 at the time of diabetes diagnosis.
- Able and willing to provide informed consent
Key exclusion criteria (2 listed)
- Gestational diabetes.
- Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetes type defined by insulin requirement at 3 years
Time frame: 3 years
Type 1 diabetes = Progression to insulin treatment and severe insulin deficiency (post meal plasma C-peptide <600pmol/L) at 3 years. Type 2 diabetes = Lack of requirement for insulin at 3 years (HbA1c <90mmol/mol without insulin treatment or post meal C-peptide ≥ 600pmol/L if insulin treated).
8 secondary outcomes
Stimulated plasma C-peptide <200pmol/L at 3 years ('absolute insulin deficiency')
Time frame: 3 years
C-peptide rate of change (UCPCR and plasma)
Time frame: 3 years
Weight change (baseline to 3 years)
Time frame: 3 years
HbA1c (mean and at 3 years)
Time frame: 3 years
Self-reported hypoglycaemia & hypoglycaemic awareness (Modified Clark and Gold)
Time frame: 3 years
Resilience (CD-RISC questionnaires)
Time frame: 3 years
Ketoacidosis (self-reported and confirmed from medical notes)
Time frame: 3 years
Wellbeing (SF12 questionnaire)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 30969375Thomas NJ, Lynam AL, Hill AV, Weedon MN, Shields BM, Oram RA, McDonald TJ, Hattersley AT, Jones AG. Type 1 diabetes defined by severe insulin deficiency occurs after 30 years of age and is commonly treated as type 2 diabetes. Diabetologia. 2019 Jul;62(7):1167-1172. doi: 10.1007/s00125-019-4863-8. Epub 2019 Apr 10.
- Results publication: PubMed 36205650Eason RJ, Thomas NJ, Hill AV, Knight BA, Carr A, Hattersley AT, McDonald TJ, Shields BM, Jones AG; StartRight Study Group. Routine Islet Autoantibody Testing in Clinically Diagnosed Adult-Onset Type 1 Diabetes Can Help Identify Misclassification and the Possibility of Successful Insulin Cessation. Diabetes Care. 2022 Dec 1;45(12):2844-2851. doi: 10.2337/dc22-0623.
- Results publication: PubMed 36802355Thomas NJ, Hill AV, Dayan CM, Oram RA, McDonald TJ, Shields BM, Jones AG; StartRight Study Group. Age of Diagnosis Does Not Alter the Presentation or Progression of Robustly Defined Adult-Onset Type 1 Diabetes. Diabetes Care. 2023 Jun 1;46(6):1156-1163. doi: 10.2337/dc22-2159.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Angus G Jones, MBBS MRCP principal investigator
Royal Devon & Exeter NHS Foundation Trust & University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Royal Devon and Exeter NHS Foundation Trust at 1 site 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes type defined by insulin requirement at 3 years (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737799, which also lists 3 linked publications.
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 4 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.