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

An incident and high risk type 1 diabetes research cohort - After Diagnosis Diabetes REsearch Support System-2 (ADDRESS-2)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN66496918
Enrollment
10000
Registered
2018-03-08
Start date
2011-07-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus

Interventions

Demographic, clinical and routine laboratory data are collected via interview with participants and from their medical records at a single study visit. An optional blood sample is collected for the me

Sponsors

Imperial College of Science, Technology and Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
There are no secondary outcome measures.

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026