Clinical trial NCT04789993: Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up
Official title: Additional Autoimmune Diseases With Type 1 Diabetes in Children and Adolescents at Diabetes Diagnostic and During Follow-up : a Monocentric Study in France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Autoimmune Diseases
Hashimoto Disease
Graves Disease
Celiac Disease
Addison Disease
Vitiligo
Keywords: Type 1 diabetes
Autoimmune Diseases
Pediatrics
Children
Adolescents
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient followed for type 1 diabetes at the Children's Hospital of Nancy, France, between 2014-01-01 and 2021-02-01.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of additional autoimmune diseases at type 1 diabetes diagnosis
timeFrame: up to 3 weeks after type 1 diabetes diagnosis
measure: Type of additional autoimmune diseases at type 1 diabetes diagnosis
timeFrame: up to 3 weeks after type 1 diabetes diagnosis
Secondary outcomes:
measure: Characteristics of patients, if additional autoimmune disease is present or absent
timeFrame: up to 3 weeks after type 1 diabetes diagnosis
measure: Occurence or non-occurence of at least one additional autoimmune diseases during follow-up
timeFrame: From type 1 diabetes diagnostic to last news date, an average of 3 years
measure: Occurence or non-occurence of each type of additional autoimmune disease during follow-up
timeFrame: From type 1 diabetes diagnostic to last news date, an average of 3 years
measure: Presence of antibodies specific to an additional autoimmune disease at type 1 diabetes diagnostic
timeFrame: up to 3 weeks after type 1 diabetes diagnosis
measure: Characteristics of patients, if at least one type of antibodies specific to an autoimmune disease is present or absent at type 1 diabetes diagnostic
timeFrame: up to 3 weeks after type 1 diabetes diagnosis
measure: Characteristics of patients, for each type of antibodies specific to an autoimmune disease, present or absent at type 1 diabetes diagnostic
timeFrame: up to 3 weeks after type 1 diabetes diagnosis
measure: Occurence or non-occurence of at least one type of antibody specific to an additional autoimmune disease
timeFrame: From type 1 diabetes diagnosis to last news date, from 1 to 6 years
measure: Occurence or non-occurence of antibodies specific to each additional autoimmune disease listed in outcome 5
timeFrame: From type 1 diabetes diagnosis to last news date, from 1 to 6 years
measure: Description of the characteristics of all the patients followed in our cohort of pediatric type 1 diabetes
timeFrame: Up to 3 weeks after type 1 diabetes diagnosis
measure: Description of the autoimmune characteristics of all the patients followed in our cohort of pediatric type 1 diabetes
timeFrame: during follow-up : From type 1 diabetes diagnosis to last news date, from 1 to 6 years
measure: If detection of antibodies specific to an additional autoimmune disease : delay between detection of these antibodies and diagnosis of the corresponding autoimmune disease
timeFrame: From type 1 diabetes diagnosis to last news date, from 1 to 6 years
measure: If patient diagnosed with Hashimoto when type 1 diabetes is diagnosed, proportion of patients with thyroid dysfunction
timeFrame: Up to 3 weeks after type 1 diabetes diagnosis
measure: Occurence of thyroid dysfunction in patients with type 1 diabetes and Hashimoto
timeFrame: From type 1 diabetes diagnosis to last news date, from 1 to 6 years
measure: Proportion of patients with thyroid dysfunction due to Hashimoto needing a specific treatment
timeFrame: Up to 3 weeks after type 1 diabetes diagnosis
measure: Occurence of specific treatment onset in patients followed for type 1 diabetes with thyroid dysfunction due to Hashimoto
timeFrame: From type 1 diabetes diagnosis to last news date, from 1 to 6 years
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Hôpital d'Enfants de Brabois
state: Lorraine
Study officials:
affiliation: Centre Hospitalo-Universitaire de Nancy, Hôpital d'Enfants de Brabois
name: Carole LEGAGNEUR, MD
role: STUDY_DIRECTOR
References: