Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric HSCT Population
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|ClinicalTrials.gov Identifier: NCT03037671|
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment|
|Hematopoietic Stem Cell Transplantation||Device: Continuous Glucose Monitor (CGM)|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric Hematopoietic Stem Cell Transplant Population|
|Actual Study Start Date :||February 9, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
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)
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.
Other Name: Abbot Freestyle Libre Pro
- The number of patients with Malgylcemia [ Time Frame: 1 week prior to transplant through maximum 60 days post-transplant; inpatient only ]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.
- The number patients that contract an infection [ Time Frame: 0-100 days post-transplant ]Infection, defined by clinically significant positive microbiology or radiology result
- The length of hospital stays for all participants [ Time Frame: Through study completion to 1 year of follow-up ]Days in the hospital post-transplant
- The length of hospital stays in the ICU for all participants [ Time Frame: Through study completion to 1 year of follow-up ]Number of days in the intensive care unit (ICU) during primary HSCT admission
- The Graft-versus-host-disease (GVHD) status of all participants [ Time Frame: Through study completion to 1 year of follow-up ]Graft-versus-host status and time to graft-versus-host will be analyzed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037671
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Jenna M Sopfe, MD||Children's Hospital Colorado|