AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type 1 diabetic subjects treated with insulin and \> 24 months since diagnosis at the time of the screening visit (existing diabetes).
* Male or female, age 8 - \<18 years at the time of the screening visit and \<18 at the time of randomization.
* HIV antibody negative at the time of the screening visit.
* M. tuberculosis (TB) negative using a QuantiFERON-TB test prior to randomization, as judged by the iInvestigator.
* Human chorionic gonadotropin (hCG) negative at the time of the screening visit, if female.
* On a continuous glucose monitoring (CGM) at the time of the screening visit, and willing to be on a CGM for the entire study, as judged by the Investigator.
* Has detectable screening C-peptide (1.5 pmol/L - 300 pmol/L or 4.5 pg/mL - 900 pg/mL).
* Informed consent and child assent, as age -appropriate, obtained before any trial-related activities. Trial -related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Legally Acceptable Representative (LAR) of the Subject must sign and date the Informed Consent Form (according to local requirements). The child must sign and date the Child Assent Form or provide oral assent, if required according to local requirements.
* Previously diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) prior to study enrollment by WHO/ADA diagnostic criteria for g…
What they're measuring
1
Change in HbA1c values
Timeframe: 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, and 5 years after initial BCG/placebo injection