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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

  • Eating Habits Questionnaire

    Other intervention

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

  • Use of an actigraphy watch

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Non-diabetic patient with cystic fibrosisExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
From enrollment to 3 months

Secondary outcomes

1

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

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

Time frame
From enrollment to 3 months
2

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

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

Time frame
From enrollment to 3 months
3

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

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

Time frame
From enrollment to 3 months
4

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

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

Time frame
From enrollment to 3 months

Other outcomes

Sponsors and contacts

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