Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis

NCT07851831 | Not Yet Recruiting

• 2 other identifiers: 69HCL25_10402026-A00194-47
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Glucose metabolism disorders in cystic fibrosis (CF-GMD) are common and have a negative clinical impact. Screening currently relies on the oral glucose tolerance test (OGTT); however, this procedure is burdensome and complex for both patients and healthcare providers. Continuous glucose monitoring (CGM) is increasingly used in CF centers for CF-GMD screening, either alone or alongside the OGTT. While long-term (one-year) OGTT reproducibility is known to be poor, the short- and medium-term reproducibility of CGM remains unknown. This examination is poised to become a major tool in CF-GMD investigation, upon which critical therapeutic decisions could be based. The primary objective of this project is to evaluate the short-term variability of CGM data.

Conditions

Glucose Metabolism Disorders in Cystic Fibrosis

Keywords

Cystic Fibrosis; Glucose metabolism disorders; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.

  The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.

  From enrollment to 3 months

Secondary Outcomes (29)

• The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)

  From enrollment to 3 months

• The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)

  From enrollment to 3 months

• The variability of other CGM parameters between M0 and M3: glycemic variability (%)

  From enrollment to 3 months

• The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)

  From enrollment to 3 months

• The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL

  From enrollment to 3 months

Study Arms (1)

Non-diabetic patient with cystic fibrosis

EXPERIMENTAL

Children aged 10 to 17 years diagnosed with cystic fibrosis (CF). Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT). Patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+).

Device: Continuous Glucose Monitoring; Other: Eating Habits Questionnaire; Other: Use of an actigraphy watch

Interventions

Continuous Glucose Monitoring DEVICE

Upon enrollment, patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+). Sensors will be placed on the posterior aspect of the dominant arm at M0, M3, and M6, and additionally on the non-dominant arm at M0 only, in order to evaluate site-dependent variability. At each time point, the sensors will be worn for 7 days to record various CGM parameters, including glycemic variability (analyzed between M0-M3 and M0-M6).

Non-diabetic patient with cystic fibrosis

Eating Habits Questionnaire OTHER

A 7-day dietary diary will be completed at M0, M3, and M6.

Non-diabetic patient with cystic fibrosis

Use of an actigraphy watch OTHER

Participants will wear an actigraphy watch during 7 days at M0, M3 and M6

Non-diabetic patient with cystic fibrosis

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 10 to 17 years
• Diagnosed with cystic fibrosis (CF)
• Managed by the pediatric CF care center (CRCM) of the Groupement Hospitalier Est
• Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT)

You may not qualify if:

• Patients with treated or untreated diabetes
• Patients presenting with a pulmonary exacerbation and currently receiving antibiotic therapy
• Patients participating in another clinical trial that could interfere, in the investigator's judgment, with the study findings
• Refusal of the patient and/or the legal guardian(s) to participate in the study
• Pregnant, parturient, or breastfeeding women
• Persons deprived of liberty by a judicial or administrative decision
• Persons undergoing psychiatric care
• Persons admitted to a healthcare or social institution for purposes other than research
• Persons not affiliated with a social security scheme or beneficiaries of a similar scheme

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant (HFME)

Bron, 69677, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Glucose Metabolism Disorders

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Kévin PERGE, Dr

CONTACT

04 72 11 88 90; kevin.perge@chu-lyon.fr

Philippe REIX, Prof

CONTACT

04 27 85 54 70; philippe.reix@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

FR (1)