RBC Lifespan Measurement in Diabetic Children
Condition: Diabetes; Red Blood Cell Survival
Study type: Interventional
Phase: Phase 1

Summary: 
      HbA1c, a measure of mean blood glucose over the lifespan of a red blood cell (RBC), is a
      marker of increasing importance both for assessing glycemic control in children with known
      diabetes and for the diagnosis of diabetes in children. HbA1c has demonstrated poor
      reliability in diagnosis and management of pediatric diabetes and the most plausible reason
      for this unreliability is that the reference ranges of HbA1c were established based on
      120-day RBC lifespan observed in adults, without considering the RBC lifespan difference
      between children and adults. The proposed studies will for the first time determine RBC
      lifespan in diabetic children
    

Detailed description: 
      Screening visit: There will be one screening visit before the study. We will do some blood
      tests that will determine if the subjects can be in this study. If the subject is qualify,
      he/she will be asked to return for the following scheduled visits.

      Study visit 1: We will draw a small amount of subject's blood from the IV. The study
      subject's blood will then be marked with biotin. We will give back the subject's blood marked
      with biotin through IV within 4 to 6 hours. Endotoxin analysis (conducted pre-infusion) and
      bacterial culture analysis (conducted post-infusion) will be performed. Twenty minutes after
      the blood transfusion, we will draw blood from the IV. After that, we will take out the IV
      and the subject can go home.

      All follow-up study visits:

      The subject will have a study visit 24 hours after receiving blood marked with biotin. After
      that, the subject will have a clinic visit every 7-10 days. These visits will end when we can
      no longer find the biotin marked blood cells in the subject's blood. This is expected to be
      approximately 12 weeks later.

      At these visits, we will draw blood and also collect all blood glucose results in the past
      7-10 days.

      After the study visits are completed, there will be one follow-up visit 4-6 months after the
      subject receives the biotin marked RBCs. We will draw about 0.25 ml of blood.

      Continuous glucose monitoring and HbA1c determination-- We will monitor continuous glucose
      concentrations throughout the study. This will be accomplished by setting up FreeStyle Libre
      Pro continuous glucose monitoring (CGM) device for each study subject. In addition, HbA1c
      will be measured once in the middle of the study (likely visit 6) and in the end of the study
      (likely visit 12).
    

Intervention name(s): biotin labeled RBCs
Intervention type(s): Drug
Intervention description(s): Autologous red blood cells are biotin labeled and transfused to the subjects. Survival of these red blood cells is tracked through examination of blood samples until no biotin-labeled red blood cells is detectable.
Other intervention name(s): biotinylated RBCs
Intervention MeSH terms: Biotin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: diabetic children; RBC lifespan