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

University of Colorado, Denver29 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hematopoietic Stem Cell Transplantation

Interventions

Continuous Glucose Monitor (CGM)DEVICE

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients age 2 to 30 years old at time of transplant. 2. Patients undergoing hematopoietic stem cell transplantation at CHCO. 3. Subject willing to wear a continuous glucose monitor for the duration of the study. 4. Subject willing to follow study protocols. Exclusion Criteria: 1. Preexisting diagnosis of type 1 diabetes, type 2 diabetes, or an insulin requirement in the 2 weeks preceding transplant. 2. Preexisting condition requiring use of steroids (other than HSCT) 3. Severe psychiatric disease or developmental delays that might interfere with ability to provide informed consent. 4. Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial. 5. Subject has an active skin condition that would affect sensor placement.

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 0-100 days post-transplant

Secondary Outcomes

The length of hospital stays for all participants

Days in the hospital post-transplant

Time frame: 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

Time frame: 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

Time frame: Through study completion to 1 year of follow-up

Data from ClinicalTrials.gov

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