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임상시험 NCT06184373 (ENGAGED)은(는) 임신성 당뇨병, 고혈당증에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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오하이오 주립 대학교Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot (ENGAGED) 20 산후
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 NCT06184373 (ENGAGED)은(는) 임신성 당뇨병, 고혈당증에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2025년 6월 6일에 시작되어 20명의 참여자를 모집하고 있습니다. 오하이오 주립 대학교이(가) 진행하며, 2027년 5월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 1월 22일에 갱신되었습니다.
간단한 개요
One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of li...더 보기
상세한 설명
Gestational diabetes (GDM) is associated with a significantly increased risk of type 2 diabetes, with 1/3 of individuals with GDM developing glucose intolerance in the first 3 years postpartum. The American Diabetes Association recommends a follow up oral glucose tolerance test (OGTT) 4-12 weeks after delivery for all patients with GDM, but rates of follow up screening are as low as 19%. OGTT presents many challenges...더 보기
공식 제목
Early Investigation of Glucose Monitoring After Gestational Diabetes (ENGAGED): Utility and Acceptability of Continuous Glucose Monitoring in the Early Postpartum Period After Gestational Diabetes Mellitus
질환명
임신성 당뇨병고혈당증기타 연구 식별자
- ENGAGED
- 2023H0066
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
Participants Participants will be recruited at 6-8 weeks postpartum; at that appointment, CGMs will be placed. After wearing the CGM, participants will fill out surveys regarding their experience. At 10-12 weeks postpartum, they will complete the standard of care OGTT as well as complete an interview regarding their experience. At 12 months postpartum, they will complete a blood test to check their hemoglobin A1c. | 연속 혈당 모니터 CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum. 경구 당부하 검사 At 10-12 weeks postpartum, participants will complete an oral glucose tolerance test, which involves drinking a glucose substance and having glucose levels measured a maximum of 3 times. 당화혈색소 At 11-14 months postpartum, participants will be asked to have their blood drawn to check their hemoglobin A1c to look for signs of developed insulin resistance |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Acceptability of CGM | As determined by survey | 15 weeks from enrollment |
Comparative experience of OGTT and CGM | As determined by survey | 15 weeks from enrollment |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Prevalence and characteristics of dysglycemia in GDM postpartum | As determined by survey | 15 weeks from enrollment |
Lifestyle changes survey | Breastfeeding practices, changes in diet and physical activity | 15 weeks from enrollment |
Medical care | Number of doctor's visits (both for participant and their infant), prescribed medications | 15 weeks from enrollment |
참여 도우미
적격성 기준
연령대
성인
최소 연령
18 Years
참여 가능한 성별
여성
건강한 참가자 허용
네
- Women with a viable singleton intrauterine pregnancy
- Able to understand the study, and having understood, provide written informed consent in English
- Recent pregnancy affected by gestational diabetes
- Pregestational Diabetes (Type I or Type II)
- Continued use of diabetes medications (including metformin and insulin) immediately after delivery
- Preterm delivery (< 37 weeks gestation)
- Twin or higher order gestation
- No access to a smartphone
- Unable or unwilling to wear CGM or return for follow up at postpartum mother-infant dyad clinic
- Participation in this trial in a prior pregnancy
- History of skin allergy to adhesive products or CGM
오하이오 주립 대학교456개의 진행 중인 임상시험 탐색 가능DexCom, Inc.연구 책임자
Rachel D'Amico, 책임연구자, Assistant Professor, Ohio State University
연구 대표 연락처
연락처: Rachel Gordon, MD, MPH, 614-293-7980, [email protected]
연락처: Seuli Brill, MD, 614-293-7980, [email protected]
1 1개국에 임상시험 장소
Ohio
Ohio State University Medical Center, Columbus, Ohio, 43210, United States
Rece Foss, 연락처, 614-293-8000, [email protected]
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