Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Monitored Cohort | The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with Malgylcemia | 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. | 1 week prior to transplant through maximum 60 days post-transplant; inpatient only |
| The number patients that contract an infection | Infection, defined by clinically significant positive microbiology or radiology result | 0-100 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| The length of hospital stays for all participants | Days in the hospital post-transplant | Through study completion to 1 year of follow-up |
| The length of hospital stays in the ICU for all participants |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
This study will enroll 23-30 subjects undergoing hematopoietic stem cell transplant at Children's Hospital Colorado.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jenna M Demedis, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of days in the intensive care unit (ICU) during primary HSCT admission
| Through study completion to 1 year of follow-up |
| The Graft-versus-host-disease (GVHD) status of all participants | Graft-versus-host status and time to graft-versus-host will be analyzed | Through study completion to 1 year of follow-up |