Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric HSCT Population

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine feasibility of using a continuous glucose monitor in pediatric, adolescent and young adult hematopoietic stem cell transplant (HSCT) recipients, and to identify the incidence and risk factors for malglycemia in primary admission for pediatric, adolescent and young adult HSCT patients as well as to characterize the relationship between outcomes and malglycemia in this population.

Detailed Description
-----------------
This study is a prospective observational cohort analysis examining the rate of malglycemia in the pediatric HSCT population and the effect of malglycemia on important post-HSCT outcomes. In addition to usual care during the peri-HSCT period, participants in this trial will be asked to wear a continuous glucose monitor for the duration of their initial hospital admission. Participants will wear this monitor while admitted to the hospital for up to one week prior to transplant, and up to 60 days after transplant.

Official Title
-----------------
Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric Hematopoietic Stem Cell Transplant Population

Conditions
-----------------
Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Device: Continuous Glucose Monitor (CGM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 2 to 30 years old at time of transplant. Patients undergoing hematopoietic stem cell transplantation at CHCO. Subject willing to wear a continuous glucose monitor for the duration of the study. Subject willing to follow study protocols. Exclusion Criteria: Preexisting diagnosis of type 1 diabetes, type 2 diabetes, or an insulin requirement in the 2 weeks preceding transplant. Preexisting condition requiring use of steroids (other than HSCT) Severe psychiatric disease or developmental delays that might interfere with ability to provide informed consent. Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial. Subject has an active skin condition that would affect sensor placement.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CGM Monitored Cohort<br>The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System. | Device: Continuous Glucose Monitor (CGM)<br>* Participants will wear the continuous glucose monitor (GCM) device during the peri-HSCT period for the duration of their initial hospital admission. No intervention based on results.<br>* Other names: Abbot Freestyle Libre Pro;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with Malgylcemia | Hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL). Participants will wear a continous glucose monitor (CGM) to measure glycemia levels. This will service both as an exposure and and outcome. | 1 week prior to transplant through maximum 60 days post-transplant; inpatient only | 
| The number patients that contract an infection | Infection, defined by clinically significant positive microbiology or radiology result | 0-100 days post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of hospital stays for all participants | Days in the hospital post-transplant | Through study completion to 1 year of follow-up | 
| The length of hospital stays in the ICU for all participants | Number of days in the intensive care unit (ICU) during primary HSCT admission | Through study completion to 1 year of follow-up | 
| The Graft-versus-host-disease (GVHD) status of all participants | Graft-versus-host status and time to graft-versus-host will be analyzed | Through study completion to 1 year of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malglycemia