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

NCT03037671 | Completed DMC

• 1 other identifier: 16-2250.cc
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Malglycemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The length of hospital stays for all participants

  Through study completion to 1 year of follow-up

• The length of hospital stays in the ICU for all participants

  Through study completion to 1 year of follow-up

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

  Through study completion to 1 year of follow-up

Study Arms (1)

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)

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.

Also known as: Abbot Freestyle Libre Pro

CGM Monitored Cohort

Eligibility Criteria

• Age: 2 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Jenna M Demedis, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 31, 2017
• Study Start: February 9, 2017
• Primary Completion: January 17, 2020
• Study Completion: April 4, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)