Type 1 DiabetesAADT1DNCT04789993
Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up
An observational study of Type 1 Diabetes and Autoimmune Diseases, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Type 1 Diabetes, Autoimmune Diseases, Hashimoto Disease
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- type 1 diabetes diagnostic not certain
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- No intervention.
- Keywords
- Type 1 diabetes, Autoimmune Diseases, Pediatrics, Children, Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases, Hashimoto Disease, Graves Disease, Celiac Disease, Addison Disease, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 3 weeks after type 1 diabetes diagnosis
Secondary outcomes (15)
Characteristics of patients, if additional autoimmune disease is present or absent
Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From type 1 diabetes diagnosis to last news date, from 1 to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start15 Mar 2021
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEGAGNEUR Carole, Central Hospital, Nancy, France
- Investigators
- Carole LEGAGNEUR, MD, Study director, Centre Hospitalo-Universitaire de Nancy, Hôpital d'Enfants de Brabois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789993
- Sponsor's protocol ID
- 2020PI283
- Acronym
- AADT1D
- Status last verified
- Mar 2021
- First submitted
- 20 Feb 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04789993
- Acronym / sponsor ID
- AADT1D / 2020PI283
- Conditions
- Type 1 Diabetes, Autoimmune Diseases, Hashimoto Disease, Graves Disease, Celiac Disease, Addison Disease
- Keywords
- Type 1 diabetes, Autoimmune Diseases, Pediatrics, Children, Adolescents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- type 1 diabetes diagnostic not certain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
Number of additional autoimmune diseases at type 1 diabetes diagnosis
Time frame: up to 3 weeks after type 1 diabetes diagnosis
Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
Type of additional autoimmune diseases at type 1 diabetes diagnosis
Time frame: up to 3 weeks after type 1 diabetes diagnosis
Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
15 secondary outcomes
Characteristics of patients, if additional autoimmune disease is present or absent
Time frame: up to 3 weeks after type 1 diabetes diagnosis
Occurence or non-occurence of at least one additional autoimmune diseases during follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 3 weeks after type 1 diabetes diagnosis
Occurence of thyroid dysfunction in patients with type 1 diabetes and Hashimoto
Time frame: 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
Time frame: 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
Time frame: From type 1 diabetes diagnosis to last news date, from 1 to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole LEGAGNEUR, MD study director
Centre Hospitalo-Universitaire de Nancy, Hôpital d'Enfants de Brabois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Autoimmune Diseases, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of additional autoimmune diseases at type 1 diabetes diagnosis (time frame: up to 3 weeks after type 1 diabetes diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.