NCT03482154

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

March 15, 2018

Last Update Submit

September 26, 2019

Conditions

Stem Cell Transplant ComplicationsHyperglycemiaHypoglycemia

Outcome Measures

Primary Outcomes (2)

  • Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients

    hypoglycemia (BG \< 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL)

    Transplant Day -14 to +100

  • Number of patients with versus without malglycemia who experience infection

    It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant infections. This outcome will be assessed for differences in incidence based on malglycemia occurence

    Transplant Day 0 to +100

Secondary Outcomes (3)

  • Determine whether specific exposures are associated with increased occurrence of malglycemia

    Transplant Day -14 to +100

  • Survival rate of patients with versus without malglycemia

    Transplant Day 0 through date of relapse or death

  • Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia

    Transplant Day 0 through date of relapse or death

Study Arms (2)

With Malglycemia

Procedure: Hematopoietic Stem Cell Transplant

Without Malglycemia

Procedure: Hematopoietic Stem Cell Transplant

Interventions

Hematopoietic Stem Cell TransplantPROCEDURE

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

With MalglycemiaWithout Malglycemia

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients who received hematopoietic stem cell transplants with the Bone Marrow Transplant Program at Children's Hospital Colorado from January 1, 2007 to July 31, 2016.

You may qualify if:

  • 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

You may not qualify if:

  • Preexisting diabetes mellitus or known hyperglycemia
  • Inadequate blood glucose data for analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

  • 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.

    PMID: 36511871DERIVED

  • 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.

    PMID: 30718242DERIVED

MeSH Terms

Conditions

HyperglycemiaHypoglycemia

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jenna Sopfe, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 29, 2018

Study Start

September 6, 2016

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)