Type 1 Diabetes Trial, Recruiting (NCT06860516)

Type 1 Diabetes Trial, Recruiting NCT06860516 Sponsor: GentiBio, Inc Condition: Type 1 Diabetes

Printed from Voxsanity (voxsanity.com.au) — NCT06860516 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Type 1 Diabetes

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:

Adults aged 18 to 55 years (male or female) who have been diagnosed with type 1 diabetes meeting standard diagnosis guidelines, which include a fasting blood sugar level of 126 mg/dL or higher, or a blood sugar level of 200 mg/dL or higher during a glucose tolerance test, or a HbA1c result of 6.5% or higher, or a random blood sugar of 200 mg/dL or higher alongside documented symptoms.
People whose type 1 diabetes was diagnosed within the last 6 months before the study visit.
People who are able and willing to sign a consent form themselves — the trial requires that participants provide their own consent directly, and no guardian or other person may sign on their behalf.

Who may not be able to join:

People who work for the company sponsoring the trial, the study site, or any contractor or vendor directly involved in running this study — or people who have an immediate family member in any of those roles.
People who are unwilling or unable to attend and complete the required study visits and assessments.

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 27 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: Mark Bach, MD, GentiBio, Inc

Phone: 85-732-75483

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06860516

Sponsor: GentiBio, Inc

Phase: Not Applicable

Status: Recruiting

Condition: Type 1 Diabetes

Trial contact: 85-732-75483

More information: https://clinicaltrials.gov/study/NCT06860516

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Adults aged 18 to 55 years (male or female) who have been diagnosed with type 1 diabetes meeting standard diagnosis guidelines, which include a fasting blood sugar level of 126 mg/dL or higher, or a blood sugar level of 200 mg/dL or higher during a glucose tolerance test, or a HbA1c result of 6.5% or higher, or a random blood sugar of 200 mg/dL or higher alongside documented symptoms.
People whose type 1 diabetes was diagnosed within the last 6 months before the study visit.
People who are able and willing to sign a consent form themselves — the trial requires that participants provide their own consent directly, and no guardian or other person may sign on their behalf.

Who may not be able to join:

People who work for the company sponsoring the trial, the study site, or any contractor or vendor directly involved in running this study — or people who have an immediate family member in any of those roles.
People who are unwilling or unable to attend and complete the required study visits and assessments.

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

GentiBio, Inc

Registry

ClinicalTrials.gov

Start date

6 June 2025

Est. completion

30 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

HLA DRB1*04:01 positive

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: 27 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