Cystic Fibrosis Pulmonary ExacerbationGeM-PExNCT06546943
Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations
An observational study of Cystic Fibrosis Pulmonary Exacerbation, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this study is to investigate the prevalence of dysglycemia with continuous glucose monitoring (CGM) obtained during pulmonary exacerbations, both outpatient and inpatient, in youth with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Cystic Fibrosis Pulmonary Exacerbation
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2022to 31 Oct 2025
- 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 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with CF ages 6 y- 25 years will be eligible to enroll. Participants will be enrolled at baseline health during a routine CF clinic visit or upon diagnosis of a pulmonary exacerbation (PEx). A PEx will be defined by treatment with either oral or IV antibiotics for an increase in respiratory symptoms as defined by a pediatric pulmonologist at our CF Center. Oral antibiotics are typically prescribed for two weeks based on clinical care guidelines developed at our center which standardize antibiotic selection based on prior respiratory culture results.
Who may be able to join
- 6- 25 years old
- Confirmed diagnosis of cystic fibrosis (based on sweat chloride and/or two known disease causing CF mutations)
- access to a smart phone and/or internet connection and the ability to complete remote telehealth visits
Who cannot join
- known type 1 or type 2 diabetes, monogenic diabetes
- critical illness requiring admission to the ICU
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado, University of Colorado Denver
Aurora, Colorado, 80045
Christine Hovater, BS, 720-777-3286, christine.hovater@childrenscolorado.org
Christine L Chan, MD
About this study
Official title: Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
The goal of this study is to investigate the prevalence of dysglycemia with continuous glucose monitoring (CGM) obtained during pulmonary exacerbations, both outpatient and inpatient, in youth with cystic fibrosis (CF).
Read the detailed description
This research is using continuous glucose monitoring (CGM) to study changes in blood sugar levels that may occur in youth with cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) who experience a pulmonary exacerbation (PEx), whether admitted to the hospital or seen in clinic. We hypothesize that 1) youth experiencing a PEx will have greater blood sugar changes during the PEx than at least 6 weeks after the PEx , 2) that the changes in blood sugars will be greater during the PEx when compared to CGM data gathered at a baseline visit prior to the PEx (when available), 3) and that blood sugar changes during the PEx will compare with changes in short-term clinical outcomes collected using questionnaires about breathing problems, and that this data will be predictive of the need for additional antibiotics. This study aims to compare CGM measures of change during a PEx with those measured after recovery; to compare CGM measures of change during the PEx to those taken at baseline; and to examine the relationships between these changes and the changes in clinical findings including the need for additional antibiotics.
- Conditions
- Cystic Fibrosis Pulmonary Exacerbation
- Keywords
- cystic fibrosis related diabetes, continuous glucose monitoring, cystic fibrosis pulmonary exacerbation
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM standard deviation
Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post)
Measured: 14 days
CGM coefficient of variation
CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post)
Measured: 14 days
MAGE (mean amplitude of glycemic excursions)
CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post)
Measured: 14 days
Secondary outcomes (6)
Forced expiratory volume at one second (FEV1) at each visit
Collected clinically at baseline during routine visits, and at the start of a pulmonary exacerbation (PEx) for those admitted inpatient and in clinic, and at next in person routine clinic visit; b)by home spirometer during routine clinic visits, and in the hone setting (if not in person) once for the baseline visit, and at the onset of exacerbation and twice/week for 14 days, and once upon recovery (at least 6 weeks after PEx)
Measured: up to 2 years
Need for additional antibiotics within 28 days following initial treatment
If initial Rx for antiobiotics proves unsuccessful and participant requires additional treatment
Measured: up to 2 years
Chronic Respiratory Infection Symptom Score questionnaire
Questionnaire tracking exacerbation symptoms
Measured: up to 2 years
sputum culture as available from clinical data
Will be collected when available from clinical data
Measured: up to 2 years
markers of inflammation when available
hsCRP (highly sensitive C-Reactive Protein) and cytokines (eg; Interleukin-6 [IL 6] \& Interleukin-8 [IL8]) at visits
Measured: up to 2 years
Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire
quality of life questionnaire
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start4 Feb 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis Pulmonary ExacerbationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546943
- Sponsor's protocol ID
- 21-3666
- Acronym
- GeM-PEx
- Status last verified
- Aug 2024
- First submitted
- 8 Nov 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
- ClinicalTrials.gov ID
- NCT06546943
- Acronym / sponsor ID
- GeM-PEx / 21-3666
- Conditions
- Cystic Fibrosis Pulmonary Exacerbation
- Keywords
- cystic fibrosis related diabetes, continuous glucose monitoring, cystic fibrosis pulmonary exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Baylor College of Medicine
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- 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.
The goal of this study is to investigate the prevalence of dysglycemia with continuous glucose monitoring (CGM) obtained during pulmonary exacerbations, both outpatient and inpatient, in youth with cystic fibrosis (CF).
Detailed description
This research is using continuous glucose monitoring (CGM) to study changes in blood sugar levels that may occur in youth with cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) who experience a pulmonary exacerbation (PEx), whether admitted to the hospital or seen in clinic. We hypothesize that 1) youth experiencing a PEx will have greater blood sugar changes during the PEx than at least 6 weeks after the PEx , 2) that the changes in blood sugars will be greater during the PEx when compared to CGM data gathered at a baseline visit prior to the PEx (when available), 3) and that blood sugar changes during the PEx will compare with changes in short-term clinical outcomes collected using questionnaires about breathing problems, and that this data will be predictive of the need for additional antibiotics. This study aims to compare CGM measures of change during a PEx with those measured after recovery; to compare CGM measures of change during the PEx to those taken at baseline; and to examine the relationships between these changes and the changes in clinical findings including the need for additional antibiotics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with CF ages 6 y- 25 years will be eligible to enroll. Participants will be enrolled at baseline health during a routine CF clinic visit or upon diagnosis of a pulmonary exacerbation (PEx). A PEx will be defined by treatment with either oral or IV antibiotics for an increase in respiratory symptoms as defined by a pediatric pulmonologist at our CF Center. Oral antibiotics are typically prescribed for two weeks based on clinical care guidelines developed at our center which standardize antibiotic selection based on prior respiratory culture results.
Key inclusion criteria (3 listed)
- 6- 25 years old
- Confirmed diagnosis of cystic fibrosis (based on sweat chloride and/or two known disease causing CF mutations)
- access to a smart phone and/or internet connection and the ability to complete remote telehealth visits
Key exclusion criteria (3 listed)
- known type 1 or type 2 diabetes, monogenic diabetes
- critical illness requiring admission to the ICU
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CGM standard deviation
Time frame: 14 days
Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post)
CGM coefficient of variation
Time frame: 14 days
CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post)
MAGE (mean amplitude of glycemic excursions)
Time frame: 14 days
CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post)
6 secondary outcomes
Forced expiratory volume at one second (FEV1) at each visit
Time frame: up to 2 years
Need for additional antibiotics within 28 days following initial treatment
Time frame: up to 2 years
Chronic Respiratory Infection Symptom Score questionnaire
Time frame: up to 2 years
sputum culture as available from clinical data
Time frame: up to 2 years
markers of inflammation when available
Time frame: up to 2 years
Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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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.
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 Cystic Fibrosis Pulmonary Exacerbation, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Hovater (720-777-6128 ext. 3286, christine.hovater@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGM standard deviation (time frame: 14 days). The study lists 3 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 9 Aug 2024.