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NCT Number: NCT03037671

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

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

2 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Abbot Freestyle Libre Pro

Primary outcomes

  1. The number of patients with Malgylcemia

    Time frame: 1 week prior to transplant through maximum 60 days post-transplant; inpatient only

    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.

  2. The number patients that contract an infection

    Time frame: 0-100 days post-transplant

    Infection, defined by clinically significant positive microbiology or radiology result

Secondary outcomes

  1. The length of hospital stays for all participants

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

    Days in the hospital post-transplant

  2. The length of hospital stays in the ICU for all participants

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

    Number of days in the intensive care unit (ICU) during primary HSCT admission

  3. The Graft-versus-host-disease (GVHD) status of all participants

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

    Graft-versus-host status and time to graft-versus-host will be analyzed

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2024
First posted
Jan 31, 2017
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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