Raw Ground Truth
Inclusion Criteria:Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.Has received a diagnosis of type 1 diabetes (T1D) according to the criteria from the American Diabetes Association.Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.Has a positive result on testing for T1D-related autoantibodies.Exclusion Criteria:Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.Has an active infection and/or fever.Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Raw Prediction
**Modified Eligibility Criteria (version 33)**
**Inclusion Criteria:**
- Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
- Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
- Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
- Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
- Has a positive result on testing for T1D-related autoantibodies.
- Has received non-infectious vaccines within 2 weeks before through 6 weeks after each dosing course.
**Exclusion Criteria:**
- Has any autoimmune disease other than T1D, with the exception of stable thyroid or celiac disease.
- Has an active infection and/or fever.
- Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- An individual who has a medical, psychological, or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
- Has a clinically active infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV) or a viral load of ≥10,000 copies per mL or per 106 lymphocytes at screening.
- Has a diagnosis of significant liver disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2X upper limit of normal (ULN) or total bilirubin (TBili) >1.5X ULN, except for subjects with Gilbert’s syndrome with normal ALT and AST with approval of the Medical Monitor.
Processed Ground Truth
1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.Has received a diagnosis of type 1 diabetes (T1D) according to the criteria from the American Diabetes Association.Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.Has a positive result on testing for T1D-related autoantibodies.Exclusion Criteria:Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.Has an active infection and/or fever.Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Processed Prediction
1. Modified Eligibility Criteria (version 33)
1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
2. Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
3. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
4. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
5. Has a positive result on testing for T1D-related autoantibodies.
6. Has received non-infectious vaccines within 2 weeks before through 6 weeks after each dosing course.
1. Has any autoimmune disease other than T1D, with the exception of stable thyroid or celiac disease.
2. Has an active infection and/or fever.
3. Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
4. An individual who has a medical, psychological, or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
5. Has a clinically active infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV) or a viral load of ≥10,000 copies per mL or per 106 lymphocytes at screening.
6. Has a diagnosis of significant liver disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2X upper limit of normal (ULN) or total bilirubin (TBili) >1.5X ULN, except for subjects with Gilbert’s syndrome with normal ALT and AST with approval of the Medical Monitor.