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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
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment
Hematopoietic Stem Cell Transplantation Device: Continuous Glucose Monitor (CGM)

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. The number patients that contract an infection [ Time Frame: 0-100 days post-transplant ]
    Infection, defined by clinically significant positive microbiology or radiology result


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll 23-30 subjects undergoing hematopoietic stem cell transplant at Children's Hospital Colorado.
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.

Information from the National Library of Medicine

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


Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Jenna M Sopfe, MD Children's Hospital Colorado

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03037671     History of Changes
Other Study ID Numbers: 16-2250.cc
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Malglycemia