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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Device: Continuous Glucose Monitor (CGM)

Study type: Observational

Funder types: Other

Identifiers

NCT03037671

16-2250.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 2 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

29 participants in 1 patient group

CGM Monitored Cohort

Description:

The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System.

Treatment:

Device: Continuous Glucose Monitor (CGM)