AbATE Follow-Up Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study proposes to conduct a non-interventional, multi-center trial that will look at
      C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who
      received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal
      antibody is a humanized antibody that is commonly used to prevent organ rejection. It was
      give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly
      diagnosed type 1 diabetes.

      The overall hypothesis of this study is there will be less change in c-peptide levels of the
      previously treated group versus the control group.
    

Detailed description: 
      We propose to conduct a non-interventional multi-center trial that will look at C-peptide
      results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received
      anti-CD3 treatment or placebo on the Abate ITN027AI trial. The first few subjects went on the
      trial late in 2005 and the last subjects were enrolled in 2009.The mixed meal tolerance tests
      will coincide with approximately 4 years and 6 years post ITN027AI study completion for each
      participant. Those participants, who completed the ITN027AI study in 2007 and 2008, will only
      have a single MMTT.

      We plan to enroll approximately 77 subjects at 5 sites who were previously active with
      ITN027AI.. Both the drug treated and the control group participants will be invited to
      participate. Along with Yale University these sites include, the University of California-San
      Francisco, University of Colorado-Barbara Davis, Benaroya Research Institute, and Pacific
      Northwest Research Institute -University of Washington. The investigators of each of these
      sites will be asked to contact their patients who were originally on the ITN027AI study.

      Subjects will be contacted via email or phone to see if they would be interested in
      participating on this Abate follow-up study. Eligible participants will come to the Yale
      University Church St. Research Unit or other participating ITN study site for either 1 or 2
      mixed meal tolerance tests to determine their current c-peptide status. The available sites
      for participants to go to include: Yale University, University of California-San Francisco,
      University of Colorado-Barbara Davis Center, Benaroya Research Institute and Pacific
      Northwest-University of Washington.

      This first visit will consist of the following: an explanation of the study, an assessment of
      inclusion/exclusion criteria and documentation of informed consent. If the subject meets the
      inclusion/exclusion criteria, a complete medical history will be obtained, physical
      examination including vital signs, urine pregnancy test if a female of childbearing potential
      and an assessment of concomitant medications. The subject will then have a Mixed Meal
      Tolerance Tests (MMTT) with a possible 2nd MMTT with C-Peptide and glucose measurements a
      year later based on how long it has been since they were on the ITN027AI Study.The subject
      will also have a 4 hour urine collection for C-peptide and creatinine during this MMTT. If a
      repeat MMTT is done a year later then another 4 hour urine sample during the MMTT will be
      collected for C-peptide and Creatinine measurement.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators will contact their patients who were originally on the ITN027AI (AbATE)
        study. Subjects will be contacted via email or phone to see if they would be interested in
        participating on this Abate follow-up study.
      
Biospecimen description: 
      blood urine
    
Keywords: T1D; type 1 diabetes; type 1 diabetes mellitus; juvenile diabetes; autoimmune diabetes; autoimmune; anti-CD3 mAb; mAb hOKT3g1(Ala-Ala); teplizumab