Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

NCT ID: NCT03482154

Last Updated: 2019-09-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-06

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stem Cell Transplant Complications Hyperglycemia Hypoglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

With Malglycemia

Hematopoietic Stem Cell Transplant

Intervention Type PROCEDURE

Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.

Without Malglycemia

Hematopoietic Stem Cell Transplant

Intervention Type PROCEDURE

Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hematopoietic Stem Cell Transplant

Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 0 to 30 years old at time of transplant
* Bone Marrow Transplant (BMT) recipient at Children's Hospital Colorado (CHCO) between 1/1/2007 and 7/31/2016

Exclusion Criteria

* Preexisting diabetes mellitus or known hyperglycemia
* Inadequate blood glucose data for analysis
Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jenna Sopfe, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Cho S, Vigers T, Pyle L, Franklin A, Sopfe J, Jeney F, Forlenza G. Composite Metric of Glycemic Control Q-Score Is Elevated in Pediatric and Adolescent/Young Adult Hematopoietic Stem Cell Transplant Recipients. Diabetes Technol Ther. 2023 Feb;25(2):116-121. doi: 10.1089/dia.2022.0246. Epub 2022 Dec 29.

Reference Type DERIVED
PMID: 36511871 (View on PubMed)

Sopfe J, Pyle L, Keating AK, Campbell K, Liu AK, Wadwa RP, Verneris MR, Giller RH, Forlenza GP. Malglycemia is associated with poor outcomes in pediatric and adolescent hematopoietic stem cell transplant patients. Blood Adv. 2019 Feb 12;3(3):350-359. doi: 10.1182/bloodadvances.2018021014.

Reference Type DERIVED
PMID: 30718242 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16-1496.cc

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.