Clinical trial NCT03037671: Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric HSCT Population
Official title: Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric Hematopoietic Stem Cell Transplant Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Malglycemia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 29
Sex: ALL
Minimum age (years): 2
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll 23-30 subjects undergoing hematopoietic stem cell transplant at Children's Hospital Colorado.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of patients with Malgylcemia
timeFrame: 1 week prior to transplant through maximum 60 days post-transplant; inpatient only
measure: The number patients that contract an infection
timeFrame: 0-100 days post-transplant
Secondary outcomes:
measure: The length of hospital stays for all participants
timeFrame: Through study completion to 1 year of follow-up
measure: The length of hospital stays in the ICU for all participants
timeFrame: Through study completion to 1 year of follow-up
measure: The Graft-versus-host-disease (GVHD) status of all participants
timeFrame: Through study completion to 1 year of follow-up
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jenna M Demedis, MD
role: PRINCIPAL_INVESTIGATOR
References: