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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Kévin PERGE, Dr
- Telefonní číslo: +33 04 72 11 88 90
- E-mail: kevin.perge@chu-lyon.fr
Studijní záloha kontaktů
- Jméno: Philippe REIX, Prof
- Telefonní číslo: +33 04 27 85 54 70
- E-mail: philippe.reix@chu-lyon.fr
Studijní místa
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Bron, Francie, 69677
- Hôpital Femme Mère Enfant (HFME)
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Kontakt:
- Philippe REIX, Prof
- Telefonní číslo: +33 04 27 85 54 70
- E-mail: philippe.reix@chu-lyon.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Časové okno: 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)
Časové okno: 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 (%)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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),
Časové okno: 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),
Časové okno: 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 (%),
Časové okno: 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),
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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),
Časové okno: 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)
Časové okno: 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 (%)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Genetické choroby, vrozené
- Metabolické choroby
- Nemoci dýchacích cest
- Nemoci trávicího systému
- Plicní onemocnění
- Kojenec, novorozenec, nemoci
- Onemocnění slinivky břišní
- Vrozené, dědičné a neonatální nemoci a abnormality
- Nutriční a metabolické nemoci
- Cystická fibróza
- Poruchy metabolismu glukózy
- Vyšetřovací techniky
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Chemická analýza krve
- Testy klinické chemie
- Diagnostické techniky, endokrinní
- Monitorování, fyziologické
- Nepřetržité monitorování glukózy
Další identifikační čísla studie
- 69HCL25_1040
- 2026-A00194-47 (Jiný identifikátor: ID-RCB)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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