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

NCT03737799 | Active Not Recruiting

• 4 other identifiers: CRF243203567CS-2015-15-01817/0005624
• Study Type: observational
• Target: 1,815
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Diabetes; C-peptide; Insulin; Classification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Stimulated plasma C-peptide <200pmol/L at 3 years ('absolute insulin deficiency')

  3 years

• C-peptide rate of change (UCPCR and plasma)

  3 years

• Weight change (baseline to 3 years)

  3 years

• HbA1c (mean and at 3 years)

  3 years

• Self-reported hypoglycaemia & hypoglycaemic awareness (Modified Clark and Gold)

  3 years

Study Arms (3)

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

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

Recently diagnosed diabetes patients in primary care, secondary care or community.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Diabetes UK: collaborator
• University of Exeter: collaborator

Study Sites (1)

Anita Hill

Exeter, Devon, EX2 5DW, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 30969375 BACKGROUND

• 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 Possibility of Successful Insulin Cessation. Diabetes Care. 2022 Dec 1;45(12):2844-2851. doi: 10.2337/dc22-0623.

  PMID: 36205650 RESULT

• 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. doi: 10.2337/dc22-2159.

  PMID: 36802355 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, DNA, RNA, Cell free DNA

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Angus G Jones, MBBS MRCP

  Royal Devon & Exeter NHS Foundation Trust & University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: November 13, 2018
• Study Start: August 1, 2016
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

GB (1)