Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and Durin… (NCT04789993) | Clinical Trial Compass
UnknownNot Applicable
Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up
France250 participantsStarted 2021-03-15
Plain-language summary
This study aims to describe the prevalence of additional autoimmune diseases and their specific antibodies at type 1 diabetes (T1D) diagnosis, and their incidence rate during follow-up, for children and adolescents. It also aims to describe the characteristics of the pediatric cohort followed since 2014 for type 1 diabetes by one of France's centers of reference for paediatric diabetes.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with type 1 diabetes diagnosed with the following criteria: (i) Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dl), or (ii) fasting plasma glucose ≥7.0 mmol/l (≥126 mg/dl) ; and (iii) presence of diabetes associated autoantibodies : ICA, GAD, IA2, IAA and/or ZnT8
* age \< 18 years old at type 1 diabetes diagnostic
* type 1 diabetes diagnosed between 2014-01-01 and 2021-02-01
Exclusion Criteria:
* type 1 diabetes diagnostic not certain
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is tracking how many and what types of autoimmune diseases — like Hashimoto's, celiac disease, and Addison's disease — show up alongside Type 1 diabetes in children, would participating mean my child gets screened for all of these conditions at diagnosis and over time, and is that screening something we should be doing regardless of this trial?
2The recruitment status for this trial is listed as unknown — can you find out whether this study is still actively enrolling, and if not, are there similar observational studies at this hospital or nearby that my child might be eligible for?
3Since this is a non-interventional, observational study with no listed phase, it wouldn't involve any experimental treatments — but what exactly would my child be asked to do, and how often would we need to come in for follow-up visits?
4Given that children with Type 1 diabetes have a higher risk of developing additional autoimmune diseases like celiac or thyroid disorders, should we be screening for these conditions as part of my child's standard diabetes care plan, even outside of a clinical trial?
5If my child were to join this study, how would the information collected be used — would we ever receive results about our child specifically, and could it change how their diabetes or any other autoimmune condition is managed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of additional autoimmune diseases at type 1 diabetes diagnosis
Timeframe: up to 3 weeks after type 1 diabetes diagnosis
2
Type of additional autoimmune diseases at type 1 diabetes diagnosis
Timeframe: up to 3 weeks after type 1 diabetes diagnosis