RecruitingPhase 2NCT05180591

Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes


Sponsor

Massachusetts General Hospital

Enrollment

150 participants

Start Date

Mar 22, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on pediatric Type 1 diabetes.


Eligibility

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether repeated BCG vaccinations (a tuberculosis vaccine that also affects the immune system) can help the immune system better regulate blood sugar in children and teenagers with Type 1 diabetes. **You may be eligible if:** - You are between 8 and 17 years old - You were diagnosed with Type 1 diabetes at least 2 years ago and are being treated with insulin - You are HIV-negative and test negative for tuberculosis - You are not pregnant (if female) - You are using a continuous glucose monitor (CGM) or willing to use one throughout the study - Your blood still produces a small but detectable amount of insulin (C-peptide levels in range) **You may NOT be eligible if:** - You were diagnosed with Type 1 diabetes less than 2 years ago - You test positive for tuberculosis - You are HIV-positive - You are pregnant - You are not willing to wear a continuous glucose monitor throughout the whole study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBacillus Calmette-Guérin

2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial

BIOLOGICALSaline Injection

2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial


Locations(1)

Immunobiology Labs CNY 149

Charlestown, Massachusetts, United States

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NCT05180591


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