Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

Conditions
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Stem Cell Transplant Complications, Hyperglycemia, Hypoglycemia

Intervention / Treatment
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* Procedure: Hematopoietic Stem Cell Transplant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With Malglycemia<br> | Procedure: Hematopoietic Stem Cell Transplant<br>* Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.<br>|
| Without Malglycemia<br> | Procedure: Hematopoietic Stem Cell Transplant<br>* Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients | hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL) | Transplant Day -14 to +100 | 
| Number of patients with versus without malglycemia who experience infection | 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 | Transplant Day 0 to +100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether specific exposures are associated with increased occurrence of malglycemia | 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 | Transplant Day -14 to +100 | 
| Survival rate of patients with versus without malglycemia | 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 | Transplant Day 0 through date of relapse or death | 
| Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia | 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 | Transplant Day 0 through date of relapse or death |