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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Kévin PERGE, Dr
- 전화번호: +33 04 72 11 88 90
- 이메일: kevin.perge@chu-lyon.fr
연구 연락처 백업
- 이름: Philippe REIX, Prof
- 전화번호: +33 04 27 85 54 70
- 이메일: philippe.reix@chu-lyon.fr
연구 장소
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Bron, 프랑스, 69677
- Hôpital Femme Mère Enfant (HFME)
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연락하다:
- Philippe REIX, Prof
- 전화번호: +33 04 27 85 54 70
- 이메일: philippe.reix@chu-lyon.fr
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
기간: From enrollment to 3 months
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The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3. |
From enrollment to 3 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
기간: 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)
기간: 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 (%)
기간: From enrollment to 3 months
|
The variability of other CGM parameters between M0 and M3: glycemic variability (%) |
From enrollment to 3 months
|
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The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
기간: 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
기간: 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)
기간: From enrollment to 3 months
|
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c) |
From enrollment to 3 months
|
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The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
기간: 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),
기간: 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),
기간: 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 (%),
기간: 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),
기간: 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
기간: 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)
기간: From enrollment to 6 months
|
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c) |
From enrollment to 6 months
|
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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)
기간: 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),
기간: 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
|
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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)
기간: 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 (%)
기간: 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)
기간: 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
기간: 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)
기간: 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
|
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The variability of CGM parameters according to physical activity (percentage of daytime activity) : Variation in the number of steps
기간: From enrollment to 3 months and 6 months
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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
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The variability of CGM parameters according to body composition (body fat percentage)
기간: 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
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The variability of CGM parameters according to body composition
기간: 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
|
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The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm)
기간: 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
|
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The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
기간: 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
|
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The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 69HCL25_1040
- 2026-A00194-47 (기타 식별자: ID-RCB)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .