StartRIGHT: A Pilot Research Study About Diabetes Diagnosis & Treatment

NCT02287506 | Terminated

• 1 other identifier: CRF166
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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 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

Diabetes

Keywords

diagnosis, strategy

Outcome Measures

Primary Outcomes (1)

• Time to optimum treatment following diagnosis.

  Optimum treatment will be determined at 3 year follow up on the basis of whether insulin is required or not (using C peptide testing if on insulin and HbA1c testing if not on insulin). If insulin is not required then the optimum treatment will be determined using the treatment guidelines for T2D or the subtype of MODY diagnosed. Treatment will be recorded 6-monthly up to 3 years.

  3 years

Secondary Outcomes (1)

• Mean glycaemic control

  3 years

Study Arms (2)

ODS from enrolment

EXPERIMENTAL

Optimised Diagnostic Strategy used from enrolment to study

Other: Optimised Diagnostic Strategy

ODS at end of study

NO INTERVENTION

ODS fed back at the end of the participants involvement with the study

Interventions

Optimised Diagnostic Strategy OTHER

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

Also known as: ODS

ODS from enrolment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recent clinical diagnosis of Diabetes (the working definition of recent will initially be within 3 months, but this may be modified if required).
• Aged 18 - 50 yrs of age at diagnosis.
• Able and willing to provide informed consent

You may not qualify if:

• Gestational diabetes
• Known secondary diabetes
• Unable/unwilling to provide informed consent

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Related Publications (5)

• Shields BM, Hicks S, Shepherd MH, Colclough K, Hattersley AT, Ellard S. Maturity-onset diabetes of the young (MODY): how many cases are we missing? Diabetologia. 2010 Dec;53(12):2504-8. doi: 10.1007/s00125-010-1799-4. Epub 2010 May 25.

  PMID: 20499044 RESULT

• Stone MA, Camosso-Stefinovic J, Wilkinson J, de Lusignan S, Hattersley AT, Khunti K. Incorrect and incomplete coding and classification of diabetes: a systematic review. Diabet Med. 2010 May;27(5):491-7. doi: 10.1111/j.1464-5491.2009.02920.x.

  PMID: 20536944 RESULT

• Seidu S, Davies MJ, Mostafa S, de Lusignan S, Khunti K. Prevalence and characteristics in coding, classification and diagnosis of diabetes in primary care. Postgrad Med J. 2014 Jan;90(1059):13-7. doi: 10.1136/postgradmedj-2013-132068. Epub 2013 Nov 13.

  PMID: 24225940 RESULT

• McDonald TJ, Colclough K, Brown R, Shields B, Shepherd M, Bingley P, Williams A, Hattersley AT, Ellard S. Islet autoantibodies can discriminate maturity-onset diabetes of the young (MODY) from Type 1 diabetes. Diabet Med. 2011 Sep;28(9):1028-33. doi: 10.1111/j.1464-5491.2011.03287.x.

  PMID: 21395678 RESULT

• Shields BM, McDonald TJ, Ellard S, Campbell MJ, Hyde C, Hattersley AT. The development and validation of a clinical prediction model to determine the probability of MODY in patients with young-onset diabetes. Diabetologia. 2012 May;55(5):1265-72. doi: 10.1007/s00125-011-2418-8. Epub 2012 Jan 5.

  PMID: 22218698 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew T Hattersley, Professor

  RD&E NHS FT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 10, 2014
• Study Start: August 28, 2015
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: September 17, 2019

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will not share