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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-09

Study Completion Date

2024-04-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematopoietic Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CGM Monitored Cohort

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

Continuous Glucose Monitor (CGM)

Intervention Type 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.

Interventions

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Continuous Glucose Monitor (CGM)

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.

Intervention Type DEVICE

Other Intervention Names

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Abbot Freestyle Libre Pro

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No