StartRight: Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes

Diabetes Mellitus Clinical Trial

— StartRight  

Official title:

StartRight: Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03737799
• Other study ID #: CRF243
• Secondary ID: 203567CS-2015-15
• Status: Active, not recruiting
• Start date: August 1, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1815
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Gestational diabetes.

• Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
United Kingdom	Anita Hill	Exeter	Devon

Sponsors (4)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	Diabetes UK, National Institute for Health Research, United Kingdom, University of Exeter

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Eason 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 P — View Citation

Thomas 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. d — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 years
Secondary	Stimulated plasma C-peptide <200pmol/L at 3 years ('absolute insulin deficiency')	C-peptide <200pmol/L at 3 years = absolute insulin deficiency	3 years
Secondary	C-peptide rate of change (UCPCR and plasma)	The rate of change of UCPCR and plasma C-peptide	3 years
Secondary	Weight change (baseline to 3 years)	Assessment of weight change from baseline to 3 year visit	3 years
Secondary	HbA1c (mean and at 3 years)	Mean HbA1c for all visits and result at 3 years	3 years
Secondary	Self-reported hypoglycaemia & hypoglycaemic awareness (Modified Clark and Gold)	Results from Hypoglycaemia questionnaire	3 years
Secondary	Resilience (CD-RISC questionnaires)	Results from analysis of data from CD-RISC questionnaire	3 years
Secondary	Ketoacidosis (self-reported and confirmed from medical notes)	Self reported Ketoacidosis and confirmation in medical notes	3 years
Secondary	Wellbeing (SF12 questionnaire)	Results from analysis of data from SF12 questionnaire	3 years