Characterising new-onset type 1 diabetes and supporting type 1 diabetes research

Not Applicable

• Conditions: Type 1 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN66496918
• Lead Sponsor: Imperial College of Science, Technology and Medicine

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28706084 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29622578 results

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-08
• Last Update Posted: 9 September 2024
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Current inclusion criteria as of 29/08/2024:
1. Age =1 years
2. Male or female
3. Clinical diagnosis of type 1 diabetes or unclassified but possible type 1 diabetes and have been diagnosed less than 6 months at the time of recruitment or the sibling of someone meeting the criteria above who has consented to the study. Sibling must be free from diabetes

Previous inclusion criteria:
1. Age =5 years
2. Male or female
3. Clinical diagnosis of type 1 diabetes or unclassified but possible type 1 diabetes and have been diagnosed less than 6 months at the time of recruitment or the sibling of someone meeting the criteria above who has consented to the study. Sibling must be free from diabetes

Exclusion Criteria

Current exclusion criteria as of 29/08/2024:
1. Children under 1 years of age
2. Individuals aged 16 years or older who are not competent to give consent
3. Recently diagnosed type 1 diabetes participants, who have been previously diagnosed with type 2 diabetes, unless the initial diagnosis of type 2 diabetes is also within 6 months prior to enrolment

Previous exclusion criteria:
1. Children under 5 years of age.
2. Individuals aged 16 years or older who are not competent to give consent.
3. Recently diagnosed type 1 diabetes participants, who have been previously diagnosed with type 2 diabetes, unless the initial diagnosis of type 2 diabetes is also within 6 months prior to enrolment

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Autoantibody status is measured in a single laboratory using established radiobinding assays at baseline and characteristics at presentation are measured using patient interviews, medical records and pathology systems at baseline.

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures.