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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kévin PERGE, Dr
- 電話番号：+33 04 72 11 88 90
- メール：kevin.perge@chu-lyon.fr
研究連絡先のバックアップ
- 名前：Philippe REIX, Prof
- 電話番号：+33 04 27 85 54 70
- メール：philippe.reix@chu-lyon.fr
研究場所
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Bron、フランス、69677
- Hôpital Femme Mère Enfant (HFME)
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コンタクト：
- Philippe REIX, Prof
- 電話番号：+33 04 27 85 54 70
- メール：philippe.reix@chu-lyon.fr
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
時間枠：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)
時間枠：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 (%)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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),
時間枠：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),
時間枠：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 (%),
時間枠：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),
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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),
時間枠：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)
時間枠：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 (%)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 69HCL25_1040
- 2026-A00194-47 (その他の識別子：ID-RCB)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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