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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Device: Continuous Glucose Monitor (CGM)

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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll 23-30 subjects undergoing hematopoietic stem cell transplant at Children's Hospital Colorado.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CGM Monitored Cohort; 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); 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

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jenna M Sopfe, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2017
• Primary Completion (Actual): January 17, 2020
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimated): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Malglycemia
• Other Study ID Numbers: 16-2250.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No