Type 1 DiabetesGLUT1DNCT07695727
Targeting GLUT1 to Control Autoimmunity in Type 1 Diabetes
An observational study of Type 1 Diabetes and Autoimmunity, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Type 1 Diabetes is an autoimmune disease in which immune cells contribute to the destruction of insulin-producing pancreatic beta cells. This study investigates whether targeting glucose transporter 1 (GLUT1), a transporter involved in immune cell metabolism, may help modulate autoimmune responses associated with Type… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Autoimmunity
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Sep 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult individuals with a documented diagnosis of Type 1 Diabetes whose peripheral blood mononuclear cell (PBMC) samples were previously collected and stored at the institutional Biobank/Biological Resources Center of IRCCS Ospedale San Raffaele. The study population consists of subjects who previously provided informed consent for the collection, storage, and research use of biological material and associated coded data. No prospective enrollment, additional sampling, or other study-specific procedures involving human participants are planned.
Who may be able to join
- PBMC samples obtained from adult subjects aged 18 years or older at the time of sample collection.
- Documented diagnosis of Type 1 Diabetes.
- PBMC samples already collected and stored in the institutional Biobank of IRCCS Ospedale San Raffaele.
- PBMC samples obtained from subjects who had previously provided written informed consent for the collection, storage, and research use of biological material and associated data.
Who cannot join
- PBMC samples obtained from subjects younger than 18 years at the time of sample collection.
- Presence of relevant concomitant diseases or clinical conditions that, in the Investigator's judgment and based on available records, may interfere with the interpretation of immunological analyses or with the study objectives.
- Insufficient sample availability, inadequate sample quality, or missing essential sample-related information preventing use of the PBMC sample for the planned research activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS San Raffaele Scientific Institute
Milan, 20132
Carla Di Dedda, PhD, +39 02 26434369, didedda.carla@hsr.it
Lorenzo Piemonti, MD, +39 0226432706, piemonti.lorenzo@hsr.it
About this study
Type 1 Diabetes is an autoimmune disease in which immune cells contribute to the destruction of insulin-producing pancreatic beta cells. This study investigates whether targeting glucose transporter 1 (GLUT1), a transporter involved in immune cell metabolism, may help modulate autoimmune responses associated with Type 1 Diabetes.
The study uses previously collected and biobanked peripheral blood mononuclear cells (PBMCs) from individuals with Type 1 Diabetes. No additional visits, blood draws, or study-specific procedures will be performed on human participants.
Read the detailed description
Type 1 Diabetes is an autoimmune disease characterized by immune-mediated destruction of pancreatic beta cells. Autoreactive T cells play a central role in this process and may persist over time within the memory T-cell compartment. Understanding the mechanisms that sustain autoreactive T-cell activation, survival, proliferation, and inflammatory function is therefore important for the development of more targeted immune-modulatory strategies.
Activated T cells undergo metabolic reprogramming to support their functional responses. In this context, glucose uptake and glycolytic metabolism are important components of T-cell activation. GLUT1 is a key glucose transporter involved in this metabolic adaptation and may contribute to the ability of autoreactive T cells to expand and maintain effector functions.
This study will use previously collected and biobanked peripheral blood mononuclear cell (PBMC) samples from individuals with Type 1 Diabetes. The PBMC samples will be retrieved in coded form, thawed, and infused into immunodeficient NOD scid gamma (NSG) mice to reconstitute a human immune system and generate humanized preclinical models. These models will be used to investigate the phenotype, activation state, metabolic profile, inflammatory function, and transcriptional features of human immune cells in relation to GLUT1 modulation. Experimental approaches include flow cytometry-based immunophenotyping, cytokine assessment, and transcriptomic analyses performed on human immune cells recovered from the humanized mice.
The study is observational and retrospective with respect to human participants. All human biological material and associated data were collected before the start of this study and are stored in coded or pseudonymized form. The study does not involve prospective enrollment of human participants, administration of an investigational product to human participants, additional biological sampling, clinical visits, or other study-specific procedures involving human participants.
The purpose of the study is to generate mechanistic and translational evidence on the role of GLUT1-dependent immune metabolism in Type 1 Diabetes-associated autoimmunity, using humanized preclinical models generated from biobanked PBMC samples. The study is intended to support the future development of targeted strategies aimed at modulating pathogenic autoreactive immune responses.
- Conditions
- Type 1 Diabetes, Autoimmunity
- Keywords
- Autoimmunity, Type 1 Diabetes, GLUT1, Humanized mice, Immunometabolism, T cells
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Adults With Type 1 Diabetes | Previously collected PBMC samples obtained from adult subjects with a documented diagnosis of Type 1 Diabetes and stored at the institutional Biobank of IRCCS Ospedale San Raffaele. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Immune Cell Engraftment/Reconstitution
Successful human immune cell engraftment/reconstitution will be assessed by detection and quantification of human CD45-positive cells and relevant immune cell subsets in peripheral blood and lymphoid tissues of recipient NOD scid gamma (NSG) mice.
Measured: 28 days after peripheral blood mononuclear cells (PBMCs) infusion
Secondary outcomes (1)
Quantitative and Phenotypic Profile of Human Immune Cell Subsets
Human immune cell subsets will be quantitatively and phenotypically analyzed after in vivo reconstitution in recipient NSG mice.
Measured: 28, 44, and 58 days after PBMC infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (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 IRCCS San RaffaeleThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Di Dedda, IRCCS San Raffaele
- Investigators
- Carla Di Dedda, PhD, Principal investigator, IRCCS San RaffaeleLorenzo Piemonti, MD, Study chair, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695727
- Sponsor's protocol ID
- SG-2024-12380508 (GLUT1D)
- Other IDs
- SG-2024-12380508
- Acronym
- GLUT1D
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study uses previously collected and biobanked PBMC samples together with associated pseudonymized data. Data sharing will be limited to aggregate or de-identified results, in accordance with applicable privacy regulations, ethics committee approval, institutional policies, and the informed consent provided by participants.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting GLUT1 to Control Autoimmunity in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07695727
- Acronym / sponsor ID
- GLUT1D / SG-2024-12380508 (GLUT1D)
- Conditions
- Type 1 Diabetes, Autoimmunity
- Keywords
- Autoimmunity, Type 1 Diabetes, GLUT1, Humanized mice, Immunometabolism, T cells
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 10 Jul 2026 (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.
Type 1 Diabetes is an autoimmune disease in which immune cells contribute to the destruction of insulin-producing pancreatic beta cells. This study investigates whether targeting glucose transporter 1 (GLUT1), a transporter involved in immune cell metabolism, may help modulate autoimmune responses associated with Type 1 Diabetes.
The study uses previously collected and biobanked peripheral blood mononuclear cells (PBMCs) from individuals with Type 1 Diabetes. No additional visits, blood draws, or study-specific procedures will be performed on human participants.
Detailed description
Type 1 Diabetes is an autoimmune disease characterized by immune-mediated destruction of pancreatic beta cells. Autoreactive T cells play a central role in this process and may persist over time within the memory T-cell compartment. Understanding the mechanisms that sustain autoreactive T-cell activation, survival, proliferation, and inflammatory function is therefore important for the development of more targeted immune-modulatory strategies.
Activated T cells undergo metabolic reprogramming to support their functional responses. In this context, glucose uptake and glycolytic metabolism are important components of T-cell activation. GLUT1 is a key glucose transporter involved in this metabolic adaptation and may contribute to the ability of autoreactive T cells to expand and maintain effector functions.
This study will use previously collected and biobanked peripheral blood mononuclear cell (PBMC) samples from individuals with Type 1 Diabetes. The PBMC samples will be retrieved in coded form, thawed, and infused into immunodeficient NOD scid gamma (NSG) mice to reconstitute a human immune system and generate humanized preclinical models. These models will be used to investigate the phenotype, activation state, metabolic profile, inflammatory function, and transcriptional features of human immune cells in relation to GLUT1 modulation. Experimental approaches include flow cytometry-based immunophenotyping, cytokine assessment, and transcriptomic analyses performed on human immune cells recovered from the humanized mice.
The study is observational and retrospective with respect to human participants. All human biological material and associated data were collected before the start of this study and are stored in coded or pseudonymized form. The study does not involve prospective enrollment of human participants, administration of an investigational product to human participants, additional biological sampling, clinical visits, or other study-specific procedures involving human participants.
The purpose of the study is to generate mechanistic and translational evidence on the role of GLUT1-dependent immune metabolism in Type 1 Diabetes-associated autoimmunity, using humanized preclinical models generated from biobanked PBMC samples. The study is intended to support the future development of targeted strategies aimed at modulating pathogenic autoreactive immune responses.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Type 1 Diabetes | – | –Previously collected PBMC samples obtained from adult subjects with a documented diagnosis of Type 1 Diabetes and stored at the institutional Biobank of IRCCS Ospedale San Raffaele. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals with a documented diagnosis of Type 1 Diabetes whose peripheral blood mononuclear cell (PBMC) samples were previously collected and stored at the institutional Biobank/Biological Resources Center of IRCCS Ospedale San Raffaele. The study population consists of subjects who previously provided informed consent for the collection, storage, and research use of biological material and associated coded data. No prospective enrollment, additional sampling, or other study-specific procedures involving human participants are planned.
Key inclusion criteria (4 listed)
- PBMC samples obtained from adult subjects aged 18 years or older at the time of sample collection.
- Documented diagnosis of Type 1 Diabetes.
- PBMC samples already collected and stored in the institutional Biobank of IRCCS Ospedale San Raffaele.
- PBMC samples obtained from subjects who had previously provided written informed consent for the collection, storage, and research use of biological material and associated data.
Key exclusion criteria (3 listed)
- PBMC samples obtained from subjects younger than 18 years at the time of sample collection.
- Presence of relevant concomitant diseases or clinical conditions that, in the Investigator's judgment and based on available records, may interfere with the interpretation of immunological analyses or with the study objectives.
- Insufficient sample availability, inadequate sample quality, or missing essential sample-related information preventing use of the PBMC sample for the planned research activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Human Immune Cell Engraftment/Reconstitution
Time frame: 28 days after peripheral blood mononuclear cells (PBMCs) infusion
Successful human immune cell engraftment/reconstitution will be assessed by detection and quantification of human CD45-positive cells and relevant immune cell subsets in peripheral blood and lymphoid tissues of recipient NOD scid gamma (NSG) mice.
1 secondary outcome
Quantitative and Phenotypic Profile of Human Immune Cell Subsets
Time frame: 28, 44, and 58 days after PBMC infusion
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 14 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study uses previously collected and biobanked PBMC samples together with associated pseudonymized data. Data sharing will be limited to aggregate or de-identified results, in accordance with applicable privacy regulations, ethics committee approval, institutional policies, and the informed consent provided by participants.
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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.
Carla Di Dedda, PhD principal investigator
IRCCS San Raffaele
Lorenzo Piemonti, MD study chair
IRCCS San Raffaele
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 Autoimmunity, run by IRCCS San Raffaele at 1 site in Italy.
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 3 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: opening soon, as of the sponsor's last update on 14 Jul 2026. 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 Italy. 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 Carla Di Dedda, PhD (+39 0226434369, didedda.carla@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Immune Cell Engraftment/Reconstitution (time frame: 28 days after peripheral blood mononuclear cells (PBMCs) infusion). 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 14 Jul 2026.