Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up

Study Overview
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Brief Summary
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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.

Official Title
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Additional Autoimmune Diseases With Type 1 Diabetes in Children and Adolescents at Diabetes Diagnostic and During Follow-up : a Monocentric Study in France

Conditions
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Type 1 Diabetes, Autoimmune Diseases, Hashimoto Disease, Graves Disease, Celiac Disease, Addison Disease, Vitiligo

Intervention / Treatment
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* Other: No intervention.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention.|There is no intervention needed. It is a retrospective cohort. The usual follow-up of type 1 diabetes is studied from its beginning to the last news of the patient.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of additional autoimmune diseases at type 1 diabetes diagnosis | Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations | up to 3 weeks after type 1 diabetes diagnosis | 
| Type of additional autoimmune diseases at type 1 diabetes diagnosis | Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations | up to 3 weeks after type 1 diabetes diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of patients, if additional autoimmune disease is present or absent | Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic | up to 3 weeks after type 1 diabetes diagnosis | 
| Occurence or non-occurence of at least one additional autoimmune diseases during follow-up | Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations | From type 1 diabetes diagnostic to last news date, an average of 3 years | 
| Occurence or non-occurence of each type of additional autoimmune disease during follow-up | Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations, in this outcome studied each one separately | From type 1 diabetes diagnostic to last news date, an average of 3 years | 
| Presence of antibodies specific to an additional autoimmune disease at type 1 diabetes diagnostic | Antibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies) | up to 3 weeks after type 1 diabetes diagnosis | 
| Characteristics of patients, if at least one type of antibodies specific to an autoimmune disease is present or absent at type 1 diabetes diagnostic | Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic | up to 3 weeks after type 1 diabetes diagnosis | 
| Characteristics of patients, for each type of antibodies specific to an autoimmune disease, present or absent at type 1 diabetes diagnostic | Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic | up to 3 weeks after type 1 diabetes diagnosis | 
| Occurence or non-occurence of at least one type of antibody specific to an additional autoimmune disease | Antibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies) | From type 1 diabetes diagnosis to last news date, from 1 to 6 years | 
| Occurence or non-occurence of antibodies specific to each additional autoimmune disease listed in outcome 5 | Antibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies) | From type 1 diabetes diagnosis to last news date, from 1 to 6 years | 
| Description of the characteristics of all the patients followed in our cohort of pediatric type 1 diabetes | Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic, presence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases | Up to 3 weeks after type 1 diabetes diagnosis | 
| Description of the autoimmune characteristics of all the patients followed in our cohort of pediatric type 1 diabetes | presence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases | during follow-up : From type 1 diabetes diagnosis to last news date, from 1 to 6 years | 
| If detection of antibodies specific to an additional autoimmune disease : delay between detection of these antibodies and diagnosis of the corresponding autoimmune disease | Antibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies) | From type 1 diabetes diagnosis to last news date, from 1 to 6 years | 
| If patient diagnosed with Hashimoto when type 1 diabetes is diagnosed, proportion of patients with thyroid dysfunction | Thyroid dysfunction : hormonal dysfunction associated to Hashimoto | Up to 3 weeks after type 1 diabetes diagnosis | 
| Occurence of thyroid dysfunction in patients with type 1 diabetes and Hashimoto | Occurence during type 1 diabetes follow-up of thyroid dysfunction in patients with Hashimoto | From type 1 diabetes diagnosis to last news date, from 1 to 6 years | 
| Proportion of patients with thyroid dysfunction due to Hashimoto needing a specific treatment |  | Up to 3 weeks after type 1 diabetes diagnosis | 
| Occurence of specific treatment onset in patients followed for type 1 diabetes with thyroid dysfunction due to Hashimoto |  | From type 1 diabetes diagnosis to last news date, from 1 to 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, Autoimmune Diseases, Pediatrics, Children, Adolescents