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

NCT04789993 | Unknown DMC

• 1 other identifier: 2020PI283
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Autoimmune Diseases; Hashimoto Disease; Graves Disease; Celiac Disease; Addison Disease; Vitiligo

Keywords

Type 1 diabetes; Autoimmune Diseases; Pediatrics; Children; Adolescents

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Characteristics of patients, if additional autoimmune disease is present or absent

  up to 3 weeks after type 1 diabetes diagnosis

• Occurence or non-occurence of at least one additional autoimmune diseases during follow-up

  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

  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

  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

  up to 3 weeks after type 1 diabetes diagnosis

Interventions

No intervention. OTHER

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.

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• type 1 diabetes diagnostic not certain

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Hôpital d'Enfants de Brabois

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases; Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Hyperthyroidism; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Adrenal Insufficiency; Adrenal Gland Diseases; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carole LEGAGNEUR, MD

  Centre Hospitalo-Universitaire de Nancy, Hôpital d'Enfants de Brabois

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 10, 2021
• Study Start: March 15, 2021
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

FR (1)