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



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:2 - 30
Updated:4/5/2019
Start Date:February 9, 2017
End Date:January 2020

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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.

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.

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.
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Jenna M Sopfe, MD
Phone: 720-777-4106
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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