MedTrace Logo

StartRIGHT: A Pilot Research Study About Diabetes Diagnosis & Treatment

NCT02287506 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-09-17

No results posted yet for this study

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 1000 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 400 participants diagnosed after age 50 treated with insulin at recruitment. 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 model.

Conditions

Interventions

OTHER

Optimised Diagnostic Strategy

(ODS) based on integrating Clinical information (a validated clinical probability model), Biomarkers (GAD, IA2 and ZnT8 autoantibodies) and Genetic testing for MODY

Sponsors & Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew T Hattersley, Professor · RD&E NHS FT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-28
Primary Completion
2016-05-31
Completion
2016-05-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287506 on ClinicalTrials.gov