임상 레이더 AI | ||
|---|---|---|
임상시험 NCT00850135은(는) 임신성 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
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes 1상, 2상 57 임산부
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 NCT00850135은(는) 진단을(를) 알아보기 위한 연구였습니다. 이 연구는 임신성 당뇨병에 대한 것이었으며, 완료 된 1상 2상 중재연구이었습니다. 연구는 2009년 2월 1일에 시작되어 57명의 참여자와 함께 진행되었습니다. 스탠퍼드 대학교이(가) 진행한 이 연구는 2015년 9월 1일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2016년 5월 19일에 갱신되었습니다.
간단한 개요
Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels. the one-hour glucola test is currently used to screen pregnant patients for gestational diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour later. We wish to compare 7-day continuous glucose monit...더 보기
상세한 설명
All pregnant patients without pre-existing diabetes will be eligible for the study. Interest in participation will be determined at their initial prenatal visit. Those that are interested will be consented. Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instruc...더 보기
공식 제목
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
질환명
임신성 당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- SU-02052009-1738
- IRB #12335 (기타 식별자) (Stanford University Medical Center IRB)
NCT 번호
실제 연구 시작일
2009-02
최신 업데이트 게시
2016-05-19
예상 연구 완료일
2015-09
계획된 등록 인원
57
연구종류
중재연구
단계/상
1상
2상
2상
상태
완료
주요 목적
진단
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
기타Continuous Glucose Monitor in pregnancy The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data...더 보기 | The Seven Continuous Glucose Monitoring System Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Correlation Between Glucose AUC and Birth Weight. | For each patient's CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values "AUC-110," "AUC-120," "AUC-130," "AUC-140," and "AUC-180," and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result. | CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000 | For our secondary outcome analyses,we chose to focus on AUC-130 because 130 mg/dL is a common threshold used when treating gestational diabetics. In addition, 130 mg/dL was the threshold used in an earlier pilot study performed at our institution because it had the best correlation with birth weight percentile.
Secondary outcomes were compared between these two groups using the chi-square test. Data were analyzed using Stata 11.2. AUC-130 values were divided into "high" and "low" at a cutoff of 22,000, which was the 90th percentile of AUC-130 values. | CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery |
적격성 기준
연령대
성인
최소 연령
18 Years
참여 가능한 성별
여성
- Pregnant patients
- Age 18-50
- Gestational age less than 28 weeks
- Minors less than 18 years of age
- Multiple gestation
- Known fetal anomalies
연구 책임자
Yasser Yehia El-Sayed, 책임연구자, Professor of Obstetrics and Gynecology, Stanford University
연락처 정보가 없습니다.
2 1개국에 임상시험 장소
California
Santa Clara Valley Medical Center, San Jose, California, 95128, United States
Stanford University School of Medicine, Stanford, California, 94305, United States