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

Completed

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Device: Continuous Glucose Monitor (CGM)

• Registration Number: NCT03037671
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Study Start: 2017-02-09
• Primary Completion: 2020-01-17
• Study Completion: 2024-04-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CGM Monitored Cohort	Continuous Glucose Monitor (CGM)	The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System.

Primary Outcome Measures

Name	Time	Method
The number of patients with Malgylcemia	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.
The number patients that contract an infection	0-100 days post-transplant	Infection, defined by clinically significant positive microbiology or radiology result

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States