Hematopoietic Stem Cell TransplantationNCT03037671
Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric HSCT Population
An observational study of Hematopoietic Stem Cell Transplantation, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 30 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2017to 4 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will enroll 23-30 subjects undergoing hematopoietic stem cell transplant at Children's Hospital Colorado.
Who may be able to join
- Patients age 2 to 30 years old at time of transplant.
- Patients undergoing hematopoietic stem cell transplantation at CHCO.
- Subject willing to wear a continuous glucose monitor for the duration of the study.
- Subject willing to follow study protocols.
Who cannot join
- Preexisting diagnosis of type 1 diabetes, type 2 diabetes, or an insulin requirement in the 2 weeks preceding transplant.
- Preexisting condition requiring use of steroids (other than HSCT)
- Severe psychiatric disease or developmental delays that might interfere with ability to provide informed consent.
- Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial.
- Subject has an active skin condition that would affect sensor placement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric Hematopoietic Stem Cell Transplant Population
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.
Read the 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.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Continuous Glucose Monitor (CGM)
- Keywords
- Malglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor (CGM)Device
Also called Abbot Freestyle Libre Pro
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.
| Study group | Role | What they receive |
|---|---|---|
| CGM Monitored Cohort | The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System. Receives: Device: Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 0-100 days post-transplant
Secondary outcomes (3)
The length of hospital stays for all participants
Days in the hospital post-transplant
Measured: Through study completion to 1 year of follow-up
The length of hospital stays in the ICU for all participants
Number of days in the intensive care unit (ICU) during primary HSCT admission
Measured: 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
Measured: Through study completion to 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start9 Feb 2017
- Primary completion17 Jan 2020
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenna M Demedis, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037671
- Sponsor's protocol ID
- 16-2250.cc
- Status last verified
- Aug 2024
- First submitted
- 25 Jan 2017
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric Hematopoietic Stem Cell Transplant Population
- ClinicalTrials.gov ID
- NCT03037671
- Acronym / sponsor ID
- 16-2250.cc
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Malglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM Monitored Cohort | – | Device: Continuous Glucose Monitor (CGM)The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System. |
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will enroll 23-30 subjects undergoing hematopoietic stem cell transplant at Children's Hospital Colorado.
Key inclusion criteria (4 listed)
- Patients age 2 to 30 years old at time of transplant.
- Patients undergoing hematopoietic stem cell transplantation at CHCO.
- Subject willing to wear a continuous glucose monitor for the duration of the study.
- Subject willing to follow study protocols.
Key exclusion criteria (5 listed)
- Preexisting diagnosis of type 1 diabetes, type 2 diabetes, or an insulin requirement in the 2 weeks preceding transplant.
- Preexisting condition requiring use of steroids (other than HSCT)
- Severe psychiatric disease or developmental delays that might interfere with ability to provide informed consent.
- Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial.
- Subject has an active skin condition that would affect sensor placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitor (CGM)Also: Abbot Freestyle Libre ProParticipants 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. | Device | CGM Monitored Cohort |
Primary outcome
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
3 secondary outcomes
The length of hospital stays for all participants
Time frame: Through study completion to 1 year of follow-up
The length of hospital stays in the ICU for all participants
Time frame: Through study completion to 1 year of follow-up
The Graft-versus-host-disease (GVHD) status of all participants
Time frame: Through study completion to 1 year of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenna M Demedis, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with Malgylcemia (time frame: 1 week prior to transplant through maximum 60 days post-transplant; inpatient only). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.