Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up (AADT1D)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Autoimmune Diseases; Type 1 Diabetes; Graves Disease; Celiac Disease; Vitiligo; Hashimoto Disease; Addison Disease
• Intervention / Treatment: Other: No intervention.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Vandoeuvre les nancy, Lorraine, France, 54500
      • Hopital D'Enfants de Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Carole LEGAGNEUR, MD, Centre Hospitalo-Universitaire de Nancy, Hôpital d'Enfants de Brabois

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: March 6, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Adolescents; Children; Pediatrics; Type 1 diabetes; Autoimmune Diseases
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Immune System Diseases; Eye Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Thyroid Diseases; Intestinal Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Malabsorption Syndromes; Pigmentation Disorders; Hypopigmentation; Adrenal Gland Diseases; Adrenal Insufficiency; Thyroiditis, Autoimmune; Thyroiditis; Diabetes Mellitus; Diabetes Mellitus, Type 1; Celiac Disease; Autoimmune Diseases; Vitiligo; Hashimoto Disease; Graves Disease; Addison Disease
• Other Study ID Numbers: 2020PI283

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No