Taking people in FranceNo phase

Studies immune T cells in young people with recent type 1 diabetes

Examines immune cells in children and teens with new type 1 diabetes.

Key facts

Who runs it: Assistance Publique - Hôpitaux de Paris
Where: Paris, FranceSee the site
Trial code: NCT06427421
Registry title: Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
Status: Recruiting
People taking part: 80 people, planned
Started: 6 May 2025
Expected to end: May 2027
Type of study: Interventional, 2 groups
Treatments tested: Frequency of Treg and Teffs
Phenotype of Treg and Teffs
RNA seq analysis
HLA typing
beta-cell autoantibody dosage
Glycated haemoglobin (HbA1C) dosage
blood glucose dosage
C-peptide dosage
Record updated: 20 November 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with newly diagnosed type 1 diabetes, and also children without type 1 diabetes as a control group.

Age: Inclusion text says 2 years to under 18 years; the registry header lists 6 Years to 18 Years.
Sex: Boys and girls can join.
Disease stage: Newly diagnosed type 1 diabetes, based on high blood sugar (more than 2g/L) and/or ketones in the blood and/or a lot of urination and thirst and/or weight loss. The control group has never had type 1 diabetes.
Earlier treatment: No oral or intravenous corticosteroids in the month before the blood sample.

Main reasons for not taking part

Other inflammatory or autoimmune disease (in the diabetes group, associated disease; in the control group, any history)
Oral or intravenous corticosteroids in the month before blood sampling
Cannot use anaesthetic cream for blood sampling
Weight under 12 kg (26 lb)
No health insurance cover, or covered only by AME

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

Newly diagnosed T1DM group:
Age ≥ 2 years and < 18 years on day of inclusion
Weight ≥ 12 kg
Newly diagnosed T1DM, diagnosis defined according to International Society of Pediatric and Adolescent Diabetes (ISPAD) criteria by: hyperglycemia > 2g/L and/or ketonemia and/or polyuro-polydipsia and/or weight loss
Absence of other associated inflammatory or autoimmune diseases
Affiliation with a health insurance scheme or beneficiary (excluding AME)
Written consent of parental guardians
Ability to understand and read French; Control group :
Age ≥ 2 years and < 18 years on the day of inclusion
Weight ≥ 12 kg
No personal history of T1DM
Affiliation with a health insurance scheme or entitled person (excluding AME)
Written consent from parental guardians
Ability to understand and read French

Who cannot take part

Use of oral or intravenous corticosteriods in the month prior to blood sampling
Use of oral or intravenous corticosteriods in the month prior to blood sampling
History of autoimmune or inflammatory disease
Newly diagnosed T1DM group:
Contraindication to the use of anaesthetic cream for blood sampling; Control group :
Contraindication to the use of anaesthetic cream for blood sampling

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 6 and 18 years old?

Where in France

Hopital Necker Enfants MaladesParis, FranceContact: Jacques BELTRAND, MD, PhDTaking people

About the trial

What the trial wants to find out

Type 1 diabetes (T1D) is caused by an autoimmune response leading to the destruction of pancreatic beta cells. The disease association with particular HLA class II alleles, particularly HLA-DQ8, indicates the implication of CD4 T cells in its aetiology. The hypothesis is therefore that T1D starts by the loss of tolerance in autoreactive CD4 T cells. This might result from alterations in conventional autoreactive CD4 T cells (Tcons), which drive disease, or autoreactive regulatory CD4 T cells expressing the transcription factor FOXP3 (Tregs), which normally maintain immune tolerance. The investigators expect that the characterization of HLA-DQ8-restricted Tcons and Tregs in recent onset HLA-DQ8+ T1D patients shall shed light on the molecular mechanisms underpinning T1D development. This knowledge will guide the development of novel cell therapies harnessing the power of genetically engineered Tregs expressing the relevant antigen receptor to restore immune homeostasis upon cell transfer. The ultimate goal is to reach a curative effect

The 2 groups in the trial

Newly diagnosed T1DM groupOther group
children aged 2 to under 18 on the day of inclusion, with a recent diagnosis of type 1 diabetes
Treatment: Frequency of Treg and Teffs, Phenotype of Treg and Teffs, RNA seq analysis, HLA typing, and beta-cell autoantibody dosage
Control groupOther group
children aged 2 to under 18 on the day of inclusion, with no history of type 1 diabetes
Treatment: Frequency of Treg and Teffs, Phenotype of Treg and Teffs, RNA seq analysis, HLA typing, beta-cell autoantibody dosage, Glycated haemoglobin (HbA1C) dosage, blood glucose dosage, and C-peptide dosage