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NCT03369821

EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)

Recruiting · Not specified · University of Exeter · registry updated 2025-12-19

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

Type 1 diabetes (T1D) results from destruction of insulin-producing beta cells in the pancreas by the body's own immune system (autoimmunity). It is not fully understood what causes this type of diabetes and why there is variation in age of onset and severity between people who develop the disease. The aim of this work is to study very unusual people who develop T1D extremely young, as babies under 2 years of age (EET1D). The investigators think that, for the condition to have developed that early, they must have an unusual or extreme form of autoimmunity. Studying people with EET1D will enable us to look at exactly what goes wrong with the immune system because they have one of the most extreme forms of the disease. Much may be learned about the disease from a small number of rare individuals. The investigators aim to confirm that they have autoimmune type 1 diabetes and then try to understand how they have developed diabetes so young by studying their immune system genes, the function of their immune system, and environmental factors (such as maternal genetics) that may play a role in their development of the disease....

Inclusion

  • Aged 0 to 70 years
  • Clinical diagnosis of diabetes \<24 months (+ evidence of WHO diabetes criteria)
  • Negative genetic test for mutations causing non-autoimmune neonatal diabetes if diagnosed \<12 months
  • Type 1 diabetes genetic risk score \>50th centile of T1D reference group, or monogenic cause of T1D.
  • T1D Controls
  • Age 0-70 years (matched to above)

Exclusion

  • Aged \>70 years
  • No diagnosis of diabetes
  • MODY (e.g. caused by HNF1A/HNF4A/HNF1B/GCK mutations), type 2 diabetes or diabetes related to pancreatic insufficiency or syndromic diabetes
  • Intercurrent illness at time of sampling for PBMCs (see below).
  • Aged \>24 months
  • Clinical diagnosis of diabetes \>24 months

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