NCT07695727

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
37mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 6, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

AutoimmunityType 1 DiabetesGLUT1Humanized miceImmunometabolismT cells

Outcome Measures

Primary Outcomes (1)

  • 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.

    28 days after peripheral blood mononuclear cells (PBMCs) infusion

Secondary Outcomes (1)

  • Quantitative and Phenotypic Profile of Human Immune Cell Subsets

    28, 44, and 58 days after PBMC infusion

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Autoimmune Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Study Officials

  • Carla Di Dedda, PhD

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR
  • Lorenzo Piemonti, MD

    IRCCS San Raffaele

    STUDY CHAIR

Central Study Contacts

Carla Di Dedda, PhD

CONTACT

Lorenzo Piemonti, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, Division of Immunology, Transplantation and Infectious Diseases

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations