Extremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)
This observational study is looking at people who developed Type 1 Diabetes (T1D) very early in life, specifically before two years of age. Researchers want to understand why some people get T1D so young, thinking it might be due to a unique or extreme immune system response. They will be studying your beta cells (which make insulin), immune system function, and specific genes related to T1D risk. The goal is to compare these factors in people with early-onset T1D to those with typical T1D, other types of diabetes, and people without diabetes. The study is currently unclear on its recruitment status and aims to enroll 300 participants.
- Study design
- This is an observational study with a planned enrollment of 300 participants. It is not specified if there are different phases or if it's blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Beta cell function will be measured within 12 months of the last participant's final visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03369821
EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)
Recruiting
Not specifiedUp to 70ObservationalUniversity of ExeterInvestigator-initiated
~300 participants
Updated 2025-12-19 on ClinicalTrials.gov
What's tested:Beta Cell Loss and Immune FunctionImmune Function with RNAseq
At a glance
Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure beta cell function in EET1D compared to T1D, NDM and non-diabetic controls.
Measured over Within 12 months of last participant's final visit.
Conditions
Where it's being run
4 sites across 4 statesWashington1
Leiden1
Devon1
United Kingdom1
Study leadership
- Richard Oram · PRINCIPAL_INVESTIGATOR · University of Exeter
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
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.
Age 0-70 years (matched to above)
Clinical diagnosis of T1D (diagnosed age 1-20 years)
Insulin treated from diagnosis.
Diagnosis of diabetes \<12 months
Diagnosis of monogenic / NDM (confirmed by Exeter Molecular Genetics Laboratory).
Aged 0 to 24 months at recruitment
Clinical diagnosis of diabetes \<24 months (+ evidence of WHO diabetes criteria)
Negative genetic test for mutations causing non-autoimmune neonatal diabetes
Type 1 diabetes genetic risk score \>50th centile of T1D reference group, or monogenic cause of T1D.
Diagnosis of diabetes \<24 months
Age 0 to 18 months at recruitment
Diagnosis of monogenic/NDM (confirmed by Exeter Molecular Genetics Laboratory).
Aged 0-6 years
Attending specified participating hospital sites for elective surgery, including but not limited to: inguinal hernia repair, umbilical/midline hernia repair, orchidopexy, gastrostomy insertion/change, hypospadias repair, cleft palate repair, excision of accessory digit, laryngoscopy, adenoidectomy, tonsillectomy, MRI under general anaesthesia, eye surgery.
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
Intercurrent illness at time of sampling for PBMCs or RNA (see below).
Aged \>6 years
Diagnosis of diabetes or other autoimmune condition
Known immunological disorder
On immunosuppressive medication
Ongoing infections/sepsis
Major congenital abnormality or significant systemic illness that may affect the immune system, e.g. metabolic disease, 22q deletion syndrome
Recent (within two weeks) febrile illness
Renal failure.
Recreational drug use (excluding cannabis use more than 1 week prior to blood sampling) - drug abuse may alter T cell function
Alcohol related illness (excessive alcohol consumption may alter T cell function)
Renal failure: Creatinine \>200 (as may alter T cell function)
Any other medical condition which, in the opinion of the investigator, would affect the safety of the subject's participation.
Pregnant or lactating (as this may limit blood sampling and affect T cell function)
Any infectious illness within the last 2 weeks if it was a febrile illness, or within 2-3 days if it was non-febrile (as this may activate T cells non-specifically)
Taking steroids or other immunosuppressive medications (as these may alter T cell function)
Received any immunoglobulin treatments or blood products in the last 3 months (as these may alter T cell function).
What this trial measures
- Measure beta cell function in EET1D compared to T1D, NDM and non-diabetic controls.Within 12 months of last participant's final visit.
C-peptide and GAD, IA2, ZnT8 autoantibody measurement