임상 레이더 AI | ||
|---|---|---|
임상시험 NCT05568134은(는) 낭포성 섬유증, 낭포성 섬유증 관련 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Alternate Measures of Glucose During OGTT Testing for CFRD 14 자택 기반
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT05568134은(는) 낭포성 섬유증, 낭포성 섬유증 관련 당뇨병에 대해 알아본 관찰연구입니다. 현재 상태는 완료입니다. 연구는 2023년 7월 17일에 시작되어 14명의 참여자와 함께 진행되었습니다. Children's Hospital of Philadelphia이(가) 진행한 이 연구는 2024년 12월 13일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 2월 24일에 갱신되었습니다.
간단한 개요
Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). The investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (CGM) and a home OGTT kit (GTT@home). If this pil...더 보기
상세한 설명
The investigators hypothesize that there will be strong agreement between plasma glucose and glucose as measured by either CGM or GTT@home at three different timepoints during an OGTT: fasting, 1-hour, and 2-hours.
공식 제목
Correlations Between CGM and Serum Glucose During OGTT Testing for CFRD
질환명
낭포성 섬유증낭포성 섬유증 관련 당뇨병기타 연구 식별자
- 22-020249
NCT 번호
실제 연구 시작일
2023-07-17
최신 업데이트 게시
2025-02-24
예상 연구 완료일
2024-12-13
계획된 등록 인원
14
연구종류
관찰연구
상태
완료
키워드
continuous glucose monitor
oral glucose tolerance test
oral glucose tolerance test
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
OGTT Cohort All enrolled participants will complete an OGTT. | 경구 당부하 검사 An oral glucose tolerance test will be completed. A fasting glucose will be measured.
Participants will drink 1.75 g/kg of dextrose (up to a maximum of 75 grams) within 10 minutes. Glucose values will be measured at 1 hour and 2 hours. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose | Differences in fasting glucose will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose. | Fasting glucose before OGTT |
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose | Differences in the 1 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose. | 1 hour mark in OGTT |
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose | Differences in the 2 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose. | 2 hour mark in OGTT |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Agreement between the categorical diagnosis of normal glucose tolerance (NGT), impaired glucose tolerance (IGT), indeterminate glycemia (INDET), and CFRD as defined by plasma glucose, CGM glucose, and GTT@home glucose. | Categorical diagnosis of glucose tolerance as measured by plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose. | Up to 2 hours |
Difference between plasma glucose and CGM measured glucose after the fasting glucose | Absolute differences between the glucose measurements will be measured in mg/dL | Up to 20 minutes after the fasting glucose |
Difference between plasma glucose and CGM measured glucose after the 1 hour mark during the OGTT. | Absolute differences between the glucose measurements will be measured in mg/dL | Up to 20 minutes after the 1 hour mark in the OGTT |
Difference between plasma glucose and CGM measured glucose after the 2 hour mark during the OGTT. | Absolute differences between the glucose measurements will be measured in mg/dL | Up to 20 minutes after the 2 hour mark in the OGTT |
The ability of untrained participants to successfully complete the GTT@home kit without any guidance from the research team | Number of steps successfully completed as measured by the GTT@home instruction manual. | Up to 2 hours |
Impact of wearing a real-time CGM on participants' awareness of the importance of screening for and diagnosing CFRD. | 60 minute semi-structured interviews will be conducted with participants. Transcripts will be analyzed using semantic content analysis | Within 2 weeks after removal of the CGM |
Perceived benefits and burdens of CGM use | Participants will complete a CGM Benefits and Burdens survey, a 16-item measure used to assess perceptions of CGM technology in people with type 1 diabetes. Surveys may be completed on paper or online, as per the participant's preference. The survey is scored on a 5-point scale (agree/disagree scale). | Within 2 weeks after removal of the CGM |
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
10 Years
참여 가능한 성별
전체
- Diagnosis of cystic fibrosis
- ≥ 10 years of age
- Fluency in written and spoken English as the GTT@Home is currently only available in English
- Hospitalization or treatment with IV antibiotics or supraphysiologic glucocorticoids within 4 weeks
- Major medical or psychiatric disorders other than CF
- Use of medications known to impact the accuracy of the Dexcom G7 (hydroxyurea, >2g acetaminophen per day)
- History of severe adhesive reactions that may lead to an inability to tolerate CGM wear
Children's Hospital of PhiladelphiaCystic Fibrosis Foundation연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States