Type 1 DiabetesBeAT1DNCT05139784
BeAT1D: Benign Autoimmunity and Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Institut National de la Santé Et de la Recherche Médicale, France at 17 sites in France.
Trial summary
National multi-center non-interventional case-control cohort study with collection of biological samples to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabetes. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Biosampling
- How many people
- 1,160 participants
- Where
- 17 sitesFrance
- Study dates
- 24 Oct 2022to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with type 1 diabetes, other forms of diabetes or autoimmune endocrinopathies and participants undergoing surgical lymphadenectomy are recruited among patients referred to participating hospital centers. Non-diabetic participants are recruited among patient's family members and via at-large calls for healthy volunteers.
Who may be able to join
- Type 1 diabetes: type 1 diabetes, as defined by hyperglycemia and long-term insulin therapy started within 6 months from clinical onset; and/or the presence of at least one anti-islet auto-antibody.
- Other forms of diabetes or autoimmune endocrinopathy: other forms of diabetes (e.g. type 2, ketosis-prone, familial, secondary, immunotherapy-induced diabetes); and/or other autoimmune endocrinopathies, isolated or multiple.
- No diabetes: absence of diabetes or impaired glucose tolerance; absence of tumor, infectious or immune pathologies, or other conditions related to autoimmune or metabolic alterations that may bias the variables under study.
- Lymphadenectomy planned in the frame of an abdominal surgery: pancreatic lymphadenectomy planned at the occasion of an abdominal surgery for the treatment of an underlying condition.
Who cannot join
- For all participants: ongoing pregnancy; known HIV/HCV infection; absence of social security coverage; placement under judicial protection; absence of signature of the informed study consent.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Jones contact
17 sites in 1 country
France17 sites, 17 recruiting
- Not yet recruiting
APHP Hôpital Avicenne
Bobigny, Île-de-France Region, 93000
Emmanuel Cosson, MD PhD
- Not yet recruiting
APHP Hôpital J. Verdier
Bondy, Île-de-France Region, 93140
Nadine Lucidarme, MD
Auriane Gibert, MD
- Not yet recruiting
APHP Hôpital L. Mourier
Colombes, Île-de-France Region, 92700
Stéphanie Gréteau-Hamoumou, MD
- Not yet recruiting
Hôpital Sud Francilien
Corbeil-Essonnes, Île-de-France Region, 91100
Alfred Penfornis, MD PhD
- Not yet recruiting
Hôpital Mignot - Service de Pédiatrie
Le Chesnay, Île-de-France Region, 78150
Catherine Ajzenman, MD
- Not yet recruiting
Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes
Le Chesnay, Île-de-France Region, 78150
Jean-Paul Beressi, MD
- Not yet recruiting
APHP Hôpital Kremlin-Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94270
Cécile Petit-Bibal, MD
- Not yet recruiting
APHP Hôpital Lariboisière
Paris, Île-de-France Region, 75010
Jean-François Gautier, MD PhD
Jean-Pierre Riveline, MD PhD
- Not yet recruiting
APHP Hôpital Saint Antoine
Paris, Île-de-France Region, 75012
Bruno Fève, MD PhD
- Not yet recruiting
APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie
Paris, Île-de-France Region, 75013
Sébastien Gaujoux, MD PhD
- Not yet recruiting
Hôpital Pitié-Salpêtrière - Service de Diabétologie
Paris, Île-de-France Region, 75013
Chloé Amouyal, MD PhD
Fabrizio Andreelli, MD PhD
- Not yet recruiting
APHP Hôpital Cochin - Service de Chirurgie
Paris, Île-de-France Region, 75014
Pierre-Philippe Massault, MD
- Recruiting
APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique
Paris, Île-de-France Region, 75014
Etienne Larger, MD PhD
- Not yet recruiting
APHP Hôpital Européen G. Pompidou
Paris, Île-de-France Region, 75015
Alina Radu, MD
- Not yet recruiting
APHP Hôpital Bichat
Paris, Île-de-France Region, 75018
Ronan Roussel, MD PhD
- Not yet recruiting
APHP Hôpital R. Debré
Paris, Île-de-France Region, 75019
Elise Bismuth, MD
- Not yet recruiting
Hôpital René Dubos
Pontoise, Île-de-France Region, 95300
Catherine Campinos, MD
About this study
National multi-center non-interventional case-control cohort study with collection of biological samples to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabetes.
Read the detailed description
The overall objective of this study is to define the differential characteristics of autoimmune T and B lymphocytes across individuals with T1D, other forms of diabetes or autoimmunity, and no disease. The hypothesis is that the characterization of the autoimmune T and B lymphocytes involved in T1D development may allow us to clarify the pathophysiological mechanisms of disease and to identify novel biomarkers for diagnostic, prognostic and therapeutic follow-up applications.
- Conditions
- Type 1 Diabetes
- Being tested
- Biosampling
- Keywords
- Type 1 diabetes, Autoimmunity, Lymphocytes, Beta cells, Biomarkers
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiosamplingOther
Collection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | As defined by the presence of hyperglycemia and/or islet auto-antibodies. Receives: Other: Biosampling | |
| Other forms of diabetes or autoimmune endocrinopathy | Type 2 diabetes, ketosis-prone diabetes, familial diabetes, secondary diabetes, immunotherapy-induced diabetes; and/or autoimmune endocrinopathies. Receives: Other: Biosampling | |
| No diabetes | No diabetes or impaired glucose tolerance; no cancer, infectious or immune pathologies; no other condition related to autoimmune and metabolic alterations that may bias the variables under study. Receives: Other: Biosampling | |
| Lymphadenectomy planned at the occasion of an abdominal surgery | Patients undergoing a lymphadenectomy during surgery for the treatment of their underlying pathology. Receives: Other: Biosampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups.
As measured by flow cytometry and sequencing techniques, with a sample size sufficient to attain a 92% statistical power and 5% alpha risk.
Frequency will be expressed as number of antigen-reactive T lymphocytes per 100,000 total T lymphocytes (e.g. 20/100,000 or 0.02%).
Phenotype will be expressed as percent of antigen-reactive T lymphocytes expressing a given phenotype, e.g. 20% naïve (CD45RA+CCR7+).
These 2 measures will be aggregated by expressing the frequency of antigen-reactive T lymphocytes per 100,000 total T lymphocytes expressing a given phenotype, e.g. 20/100,000 antigen-reactive T lymphocytes with 20% naïve will be expressed as 4/100,000 naive antigen-reactive T lymphocytes.
Measured: 6 years
Secondary outcomes (7)
To define the frequency and phenotype of autoimmune B lymphocytes reactive to islet antigens in the different study groups.
As measured by flow cytometry and sequencing techniques, with a sample size sufficient to attain a 92% statistical power and 5% alpha risk.
Frequency will be expressed as number of antigen-reactive B lymphocytes per 100,000 total B lymphocytes (e.g. 20/100,000 or 0.02%).
Phenotype will be expressed as percent of antigen-reactive B lymphocytes expressing a given phenotype, e.g. 20% memory (CD24+CD38-negative).
These 2 measures will be aggregated by expressing the frequency of antigen-reactive B lymphocytes per 100,000 total B lymphocytes expressing a given phenotype, e.g. 20/100,000 antigen-reactive B lymphocytes with 20% memory will be expressed as 4/100,000 memory antigen-reactive B lymphocytes.
Measured: 6 years
To identify novel islet epitopes recognized by autoimmune T and B lymphocytes.
As measured by a lymphocyte frequency within the expected range, e.g. 1-50/million.
Measured: 6 years
To define the phenotype of these lymphocytes.
As defined by exploratory analyses based on omics techniques.
Measured: 6 years
To define the pathogenicity of these lymphocytes against pancreatic beta cells.
As measured by an in vitro killing of beta-cell targets significantly (e.g. >2-fold) higher than the killing observed with control lymphocytes.
Measured: 6 years
To define the antigen receptors used by these lymphocytes to recognize their target epitopes.
As defined by sequencing techniques and sequence annotation using IMGT and MiXCR. Sequence sharing and similarities across receptors will be measured using MiXCR and stringdist.
Measured: 6 years
To define the correlation between the biomarkers analyzed and insulin secretion.
As measured based on the correlation with fasting C-peptide levels >0.2 nM.
Measured: 6 years
To define the differences between lymphocytes in the blood and those in pancreatic lymph nodes.
As measured using the previous frequency and phenotype readouts.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start24 Oct 2022
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (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 Institut National de la Santé Et de la Recherche Médicale, 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Roberto Mallone, MD PhD, Principal investigator, INSERM U1016 Cochin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139784
- Sponsor's protocol ID
- C20-61
- Other IDs
- 2021-A01619-32
- Acronym
- BeAT1D
- Status last verified
- May 2026
- First submitted
- 29 Oct 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BeAT1D: Benign Autoimmunity and Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05139784
- Acronym / sponsor ID
- BeAT1D / C20-61
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Autoimmunity, Lymphocytes, Beta cells, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 1 Dec 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.
National multi-center non-interventional case-control cohort study with collection of biological samples to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabetes.
Detailed description
The overall objective of this study is to define the differential characteristics of autoimmune T and B lymphocytes across individuals with T1D, other forms of diabetes or autoimmunity, and no disease. The hypothesis is that the characterization of the autoimmune T and B lymphocytes involved in T1D development may allow us to clarify the pathophysiological mechanisms of disease and to identify novel biomarkers for diagnostic, prognostic and therapeutic follow-up applications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | Other: BiosamplingAs defined by the presence of hyperglycemia and/or islet auto-antibodies. |
| Other forms of diabetes or autoimmune endocrinopathy | – | Other: BiosamplingType 2 diabetes, ketosis-prone diabetes, familial diabetes, secondary diabetes, immunotherapy-induced diabetes; and/or autoimmune endocrinopathies. |
| No diabetes | – | Other: BiosamplingNo diabetes or impaired glucose tolerance; no cancer, infectious or immune pathologies; no other condition related to autoimmune and metabolic alterations that may bias the variables under study. |
| Lymphadenectomy planned at the occasion of an abdominal surgery | – | Other: BiosamplingPatients undergoing a lymphadenectomy during surgery for the treatment of their underlying pathology. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with type 1 diabetes, other forms of diabetes or autoimmune endocrinopathies and participants undergoing surgical lymphadenectomy are recruited among patients referred to participating hospital centers. Non-diabetic participants are recruited among patient's family members and via at-large calls for healthy volunteers.
Key inclusion criteria (4 listed)
- Type 1 diabetes: type 1 diabetes, as defined by hyperglycemia and long-term insulin therapy started within 6 months from clinical onset; and/or the presence of at least one anti-islet auto-antibody.
- Other forms of diabetes or autoimmune endocrinopathy: other forms of diabetes (e.g. type 2, ketosis-prone, familial, secondary, immunotherapy-induced diabetes); and/or other autoimmune endocrinopathies, isolated or multiple.
- No diabetes: absence of diabetes or impaired glucose tolerance; absence of tumor, infectious or immune pathologies, or other conditions related to autoimmune or metabolic alterations that may bias the variables under study.
- Lymphadenectomy planned in the frame of an abdominal surgery: pancreatic lymphadenectomy planned at the occasion of an abdominal surgery for the treatment of an underlying condition.
Key exclusion criteria (1 listed)
- For all participants: ongoing pregnancy; known HIV/HCV infection; absence of social security coverage; placement under judicial protection; absence of signature of the informed study consent.
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 |
|---|---|---|
| BiosamplingCollection of blood and stool specimens; and collection of lymph node specimens for the group undergoing surgical lymphadenectomy. | Other | Lymphadenectomy planned at the occasion of an abdominal surgery, No diabetes, Other forms of diabetes or autoimmune endocrinopathy, Type 1 diabetes |
Primary outcome
To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups.
Time frame: 6 years
As measured by flow cytometry and sequencing techniques, with a sample size sufficient to attain a 92% statistical power and 5% alpha risk. Frequency will be expressed as number of antigen-reactive T lymphocytes per 100,000 total T lymphocytes (e.g. 20/100,000 or 0.02%). Phenotype will be expressed as percent of antigen-reactive T lymphocytes expressing a given phenotype, e.g. 20% naïve (CD45RA+CCR7+). These 2 measures will be aggregated by expressing the frequency of antigen-reactive T lymphocytes per 100,000 total T lymphocytes expressing a given phenotype, e.g. 20/100,000 antigen-reactive T lymphocytes with 20% naïve will be expressed as 4/100,000 naive antigen-reactive T lymphocytes.
7 secondary outcomes
To define the frequency and phenotype of autoimmune B lymphocytes reactive to islet antigens in the different study groups.
Time frame: 6 years
To identify novel islet epitopes recognized by autoimmune T and B lymphocytes.
Time frame: 6 years
To define the phenotype of these lymphocytes.
Time frame: 6 years
To define the pathogenicity of these lymphocytes against pancreatic beta cells.
Time frame: 6 years
To define the antigen receptors used by these lymphocytes to recognize their target epitopes.
Time frame: 6 years
To define the correlation between the biomarkers analyzed and insulin secretion.
Time frame: 6 years
To define the differences between lymphocytes in the blood and those in pancreatic lymph nodes.
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Anna Jones contact
Roberto Mallone, MD PhD principal investigator
INSERM U1016 Cochin Institute
17 sites 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, run by Institut National de la Santé Et de la Recherche Médicale, France at 17 sites 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 4 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Mallone, MD PhD (+33176535583, roberto.mallone@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens in the different study groups. (time frame: 6 years). 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 22 May 2026.