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)

Registry ID
ISRCTN66496918
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Imperial College of Science, Technology and Medicine
Enrollment
10000
Start date
2011-07-01
Completion date
2026-12-31
Last update
2026-08-17

Conditions

Summary

Type 1 diabetes mellitus

Detailed description

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 measurement of islet autoantibodies (markers of autoimmune activity in type 1 diabetes), extraction and storage of DNA and storage of blood. Within the first year of diagnosis, follow-up data are collected from medical records to confirm or record a change in diabetes sub-type.

Interventions

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

Locations

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