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New treatment option for Type 1 Diabetes
Official title Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
ClinicalTrials.gov ID: NCT06427421
What this study is testing
What is Frequency of Treg and Teffs?
Frequency of Treg and Teffs is an investigational medicine, being studied as a potential treatment for type 1 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- 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 \>...
- Absence of other associated inflammatory or autoimmune diseases;
You likely can't join if
- Newly diagnosed T1DM group:
- Use of oral or intravenous corticosteriods in the month prior to blood sampling
- Contraindication to the use of anaesthetic cream for blood sampling. Control group :
- History of autoimmune or inflammatory disease
- Use of oral or intravenous corticosteriods in the month prior to blood sampling
- Contraindication to the use of anaesthetic cream for blood sampling
See the full eligibility criteria
- 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.
- Newly diagnosed T1DM group:
- Use of oral or intravenous corticosteriods in the month prior to blood sampling
- Contraindication to the use of anaesthetic cream for blood sampling. Control group :
- History of autoimmune or inflammatory disease
- Use of oral or intravenous corticosteriods in the month prior to blood sampling
- Contraindication to the use of anaesthetic cream for blood sampling
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.