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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

Tracking Information
First Submitted Date January 25, 2017
First Posted Date January 31, 2017
Last Update Posted Date April 3, 2019
Actual Study Start Date February 9, 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2017)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03037671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 27, 2017)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric HSCT Population
Official Title Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric Hematopoietic Stem Cell Transplant Population
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will enroll 23-30 subjects undergoing hematopoietic stem cell transplant at Children's Hospital Colorado.
Condition Hematopoietic Stem Cell Transplantation
Intervention 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
Study Groups/Cohorts CGM Monitored Cohort
The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System.
Intervention: Device: Continuous Glucose Monitor (CGM)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 27, 2017)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03037671
Other Study ID Numbers 16-2250.cc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: Jenna M Sopfe, MD Children's Hospital Colorado
PRS Account University of Colorado, Denver
Verification Date April 2019