Type 1 Diabetes Trial, Recruiting NCT05767450 Sponsor: IRCCS San Raffaele Condition: Type 1 Diabetes
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Type 1 Diabetes Trial, Recruiting

NCT05767450
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been clinically diagnosed with insulin-dependent type 1 diabetes
  • People who have tested positive for at least one specific diabetes-related antibody (these are markers in the blood that indicate the immune system is affecting insulin-producing cells)
  • People who received their first insulin injection no more than 3 months ago
  • People who are aged 7 years old up to (but not including) 18 years old

Who may not be able to join:

  • People who have been diagnosed with celiac disease, inflammatory bowel disease (IBD), or other conditions causing inflammation in the intestines
  • People who have been diagnosed with tuberculosis, hepatitis B or C, HIV, or currently active Epstein-Barr virus or cytomegalovirus infection; serious heart disease; conditions affecting immune system function or blood cell abnormalities (including cancer, low lymphocyte counts, low platelet counts, or anaemia); or liver or kidney problems
  • People who are currently taking regular medications other than insulin
  • People who have taken antibiotics within the month before the treatment start date
  • People who, in the trial site's assessment, are unlikely to be able to follow the study requirements, or who have other medical issues or abnormal lab results that could interfere with the study or increase health risks

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Marika Falcone, IRCCS San Raffaele

Phone: 00390226434890

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
IRCCS San Raffaele
Registry
ClinicalTrials.gov
Start date
16 December 2022
Est. completion
30 June 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Preservation of the residual insulin-producing beta cell mass; Glycemic control by Time-in-Range (TIR) monitoring

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov