Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis (CGMUCODIAB)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Kévin PERGE, Dr
- Telefonnummer: +33 04 72 11 88 90
- E-post: kevin.perge@chu-lyon.fr
Studera Kontakt Backup
- Namn: Philippe REIX, Prof
- Telefonnummer: +33 04 27 85 54 70
- E-post: philippe.reix@chu-lyon.fr
Studieorter
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Bron, Frankrike, 69677
- Hôpital Femme Mère Enfant (HFME)
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Kontakt:
- Philippe REIX, Prof
- Telefonnummer: +33 04 27 85 54 70
- E-post: philippe.reix@chu-lyon.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Non-diabetic patient with cystic fibrosis
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+). |
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). A 7-day dietary diary will be completed at M0, M3, and M6. Participants will wear an actigraphy watch during 7 days at M0, M3 and M6 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Tidsram: From enrollment to 3 months
|
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3. |
From enrollment to 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Tidsram: From enrollment to 3 months
|
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)
Tidsram: 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 (%)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
|
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
Tidsram: From enrollment to 3 months
|
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c) |
From enrollment to 3 months
|
|
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
Tidsram: From enrollment to 6 months
|
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL) |
From enrollment to 6 months
|
|
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
Tidsram: From enrollment to 6 months
|
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL), |
From enrollment to 6 months
|
|
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
Tidsram: From enrollment to 6 months
|
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL), |
From enrollment to 6 months
|
|
The variability of CGM parameters between M0 and M6: glycemic variability (%),
Tidsram: From enrollment to 6 months
|
The variability of CGM parameters between M0 and M6: glycemic variability (%), |
From enrollment to 6 months
|
|
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
Tidsram: From enrollment to 6 months
|
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL), |
From enrollment to 6 months
|
|
The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
Tidsram: From enrollment to 6 months
|
The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL |
From enrollment to 6 months
|
|
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
Tidsram: From enrollment to 6 months
|
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c) |
From enrollment to 6 months
|
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL)
Tidsram: From enrollment to 3 months
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL) |
From enrollment to 3 months
|
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (<70 mg/dL),
Tidsram: From enrollment to 3 months
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (<70 mg/dL), |
From enrollment to 3 months
|
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg/dL)
Tidsram: From enrollment to 3 months
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg/dL) |
From enrollment to 3 months
|
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)
Tidsram: From enrollment to 3 months
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%) |
From enrollment to 3 months
|
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL)
Tidsram: From enrollment to 3 months
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL) |
From enrollment to 3 months
|
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg/dL
Tidsram: From enrollment to 3 months
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg/dL |
From enrollment to 3 months
|
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)
Tidsram: From enrollment to 3 months
|
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c) |
From enrollment to 3 months
|
|
The variability of CGM parameters according to physical activity (percentage of daytime activity) : Variation in the number of steps
Tidsram: From enrollment to 3 months and 6 months
|
The variability of CGM parameters according to physical activity (percentage of daytime activity), Variation in the number of steps |
From enrollment to 3 months and 6 months
|
|
The variability of CGM parameters according to body composition (body fat percentage)
Tidsram: From enrollment to 3 months and 6 months
|
The variability of CGM parameters according to body composition (body fat percentage) : body fat in kg |
From enrollment to 3 months and 6 months
|
|
The variability of CGM parameters according to body composition
Tidsram: From enrollment to 3 months and 6 months
|
The variability of CGM parameters according to body composition (lean mass percentage) : body fat in kg |
From enrollment to 3 months and 6 months
|
|
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm)
Tidsram: From enrollment to 3 months and 6 months
|
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm) : body fat in kg |
From enrollment to 3 months and 6 months
|
|
The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
Tidsram: From enrollment to 3 months and 6 months
|
The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg |
From enrollment to 3 months and 6 months
|
|
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
Tidsram: From enrollment to 3 months and 6 months
|
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal) |
From enrollment to 3 months and 6 months
|
|
The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
Tidsram: From enrollment to 3 months ans 6 months
|
The variability of CGM parameters according to nutritional intake : carbohydrates (kg) |
From enrollment to 3 months ans 6 months
|
|
The variability of CGM parameters according to nutritional intake : fats (kg)
Tidsram: From enrollment to 3 months and 6 months
|
The variability of CGM parameters according to nutritional intake : fats (kg) |
From enrollment to 3 months and 6 months
|
|
The variability of CGM parameters according to nutritional intake : proteins (kg)
Tidsram: From enrollment to 3 months and 6 months
|
The variability of CGM parameters according to nutritional intake : proteins (kg) |
From enrollment to 3 months and 6 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Genetiska sjukdomar, medfödda
- Metaboliska sjukdomar
- Luftvägssjukdomar
- Matsmältningssystemets sjukdomar
- Lungsjukdomar
- Spädbarn, nyfödda, sjukdomar
- Bukspottkörtelsjukdomar
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Närings- och metabola sjukdomar
- Cystisk fibros
- Störningar i glukosmetabolism
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Blodkemisk analys
- Klinisk kemi -test
- Diagnostiska tekniker, endokrin
- Övervakning, fysiologisk
- Kontinuerlig glukosövervakning
Andra studie-ID-nummer
- 69HCL25_1040
- 2026-A00194-47 (Annan identifierare: ID-RCB)
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