Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

Overview

This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 30, 2019

Detailed Description

This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.

Interventions

  • Procedure: Hematopoietic Stem Cell Transplant
    • Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.

Arms, Groups and Cohorts

  • With Malglycemia
  • Without Malglycemia

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients
    • Time Frame: Transplant Day -14 to +100
    • hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL)
  • Number of patients with versus without malglycemia who experience infection
    • Time Frame: Transplant Day 0 to +100
    • It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant infections. This outcome will be assessed for differences in incidence based on malglycemia occurence

Secondary Measures

  • Determine whether specific exposures are associated with increased occurrence of malglycemia
    • Time Frame: Transplant Day -14 to +100
    • The occurrence of the outcome, malglycemia, with be assessed for differences in incidence that may occur as a result of age, medication exposures (use of glucocorticoids, asparaginase, total parenteral nutrition (TPN), or calcineurin inhibitors), underlying diagnosis, and transplant type
  • Survival rate of patients with versus without malglycemia
    • Time Frame: Transplant Day 0 through date of relapse or death
    • It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant mortality. This outcome will be assessed for differences in incidence based on malglycemia occurrence
  • Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia
    • Time Frame: Transplant Day 0 through date of relapse or death
    • It is hypothesized that patients who experience malglycemia will have an increased rate of GVHD. This outcome will be assessed for differences in incidence based on malglycemia occurrence

Participating in This Clinical Trial

Inclusion Criteria

  • Age 0 to 30 years old at time of transplant – Bone Marrow Transplant (BMT) recipient at Children's Hospital Colorado (CHCO) between 1/1/2007 and 7/31/2016 Exclusion Criteria:

  • Preexisting diabetes mellitus or known hyperglycemia – Inadequate blood glucose data for analysis

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jenna Sopfe, MD, Principal Investigator, Children’s Hospital Colorado

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