Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)

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).

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis Pulmonary Exacerbation

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Christine Hovater; Phone Number: 3286 720-777-6128; Email: christine.hovater@childrenscolorado.org
• Study Contact Backup: Name: Christine Chan, MD; Phone Number: 0990 720-777-6128; Email: christinel.chan@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado, University of Colorado Denver
      • Contact: Christine Hovater, BS; Phone Number: 720-777-3286; Email: christine.hovater@childrenscolorado.org
      • Principal Investigator: Christine L Chan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• known type 1 or type 2 diabetes, monogenic diabetes
• critical illness requiring admission to the ICU
• pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM standard deviation	Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post)	14 days
CGM coefficient of variation	CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post)	14 days
MAGE (mean amplitude of glycemic excursions)	CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post)	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	up to 2 years
Chronic Respiratory Infection Symptom Score questionnaire	Questionnaire tracking exacerbation symptoms	up to 2 years
sputum culture as available from clinical data	Will be collected when available from clinical data	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	up to 2 years
Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire	quality of life questionnaire	up to 2 years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Baylor College of Medicine; Cystic Fibrosis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: continuous glucose monitoring; cystic fibrosis related diabetes; cystic fibrosis pulmonary exacerbation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 21-3666

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No