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Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management 4상 200 임산부

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임상시험 NCT07224893은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 임신 전 당뇨병, 임신에 대해 진행되며, 4상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2025년 12월 1일부터 가능하며, 200명의 참여자를 모집할 예정입니다. Eastern Virginia Medical School이(가) 진행하는 이 연구는 2027년 12월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 5일에 갱신되었습니다.
간단한 개요
The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the st...더 보기
공식 제목

Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin

질환명
임신 전 당뇨병임신
출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.
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기타 연구 식별자
  • 25-09-FB-0214
NCT 번호
NCT07224893
실제 연구 시작일
2025-12-01
최신 업데이트 게시
2025-11-05
예상 연구 완료일
2027-12-01
계획된 등록 인원
200
연구종류
중재연구
단계/상
4상
상태
대상자모집전
키워드
continuous glucose monitoring
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
활성 대조군Once-Daily Insulin Glargine
Participants randomized to this arm will take insulin glargine once daily
Use of insulin glargine once daily
Insulin glargine will be used once daily
실험적Twice-Daily Insulin Glargine
Participants randomized to this arm will take insulin glargine twice daily
Use of insulin glargine twice daily
Insulin glargine will be used twice daily
주요결과변수
결과변수측정값 설명시간 범위
Weekly Time in Range
The mean blood glucose time in range as measured by the continuous glucose monitor
From Day 7 to Day 14 after study enrollment
이차결과변수
결과변수측정값 설명시간 범위
Hypertensive disorders of pregnancy
Development of hypertensive disorders of pregnancy
From time of enrollment until time of delivery, up to 20 weeks following enrollment
Preterm birth <34 weeks
Delivery at less than 34 weeks gestation
From time of enrollment to 34 weeks gestation
Preterm birth <37 weeks
Delivery prior to 37 weeks gestation
From time of enrollment until 37 weeks gestation
Spontaneous or Indicated Delivery
Whether delivery was spontaneous or there was an indication for induction or cesarean delivery
From time of enrollment until time of delivery, up to 20 weeks following enrollment
Operative vaginal delivery
Whether an operative vaginal delivery was indicated
From time of enrollment to time of delivery, up to 20 weeks following enrollment
Cesarean Delivery
Whether a cesarean delivery was indicated
From time of enrollment to time of delivery, up to 20 weeks following enrollment
Estimated blood loss
The estimated blood loss during delivery
Duration of labor, up to 24 hours
Quantitative blood loss
The quantified blood loss during delivery
Duration of labor, up to 24 hours
Blood transfusion
Whether a blood transfusion was necessary during or following delivery
From time of enrollment until hospital discharge (up to 42 days post-delivery)
Endometritis
Incidence of endometritis (inflammation of uterine lining)
From time of enrollment to hospital discharge (up to 42 days post-delivery)
Chorioamnionitis
Incidence of chorioamnionitis (placental and amniotic membrane infection)
From time of enrollment until time of hospital discharge (up to 42 days post-delivery)
Wound infection
Infection of wounds left by labor
From time of enrollment to hospital discharge (up to 42 days post-delivery)
Venous thromboembolism
Incidence of venous thromboembolism
From time of enrollment to time of hospital discharge (up to 42 days post-delivery)
Massive transfusion and postpartum hemorrhage
Incidence of massive transfusion and postpartum hemorrhage
From time of enrollment until hospital discharge (up to 42 days post-delivery)
ICU admission
Admission to the ICU
From time of enrollment until hospital discharge (up to 42 days post-delivery)
Maternal death
From time of enrollment to hospital discharge (up to 42 days post-delivery)
Antepartum death
Fetal death
From time of enrollment to time of delivery, up to 20 weeks following enrollment
Intrapartum death
Fetal death during labor and delivery
Duration of labor, up to 24 hours
Neonatal Intubation within 72 hours of birth
From time of delivery to 72 hours later
Continuous positive airway pressure (CPAP) within 72 hours of birth
Use of CPAP for neonate within 72 hours of birth
From time of delivery to 72 hours later
High-flow nasal cannula (HFNC) within 72 hours of birth
From time of delivery to 72 hours later
Cardiopulmonary resuscitation within 72 hours of birth
From time of delivery to 72 hours later
Neonatal Hypoglycemia (glucose <35 mg/dL) requiring IV glucose therapy
From time of delivery to time of hospital discharge, up to 1 year following delivery
Birthweight
Infant birthweight
From time of delivery to time of hospital discharge, up to 1 year following delivery
Neonatal encephalopathy
From time of delivery to time of hospital discharge, up to 1 year following delivery
Seizures
Incidence of neonatal seizures
From time of delivery to time of hospital discharge, up to 1 year following delivery
Shoulder dystocia
Incidence of shoulder dystocia
From time of delivery to time of hospital discharge, up to 1 year following delivery
Birth trauma
Incidence of neonatal birth trauma
From time of delivery to time of hospital discharge, up to 1 year following delivery
Intracranial hemorrhage
Incidence of neonatal intracranial hemorrhage
From time of delivery to time of hospital discharge, up to 1 year following delivery
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Incidence of neonatal hyperbilirubinemia requiring phototherapy or exchange transfusion
From time of delivery to time of hospital discharge, up to 1 year following delivery
NICU admission
Admission of neonate to the neonatal intensive care unit
From time of delivery to time of hospital discharge, up to 1 year following delivery
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
여성
  • Patients older than 18 years of age;
  • The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
  • Type II diabetes mellitus requiring insulin;
  • The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.
  • Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management

  • Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated;
  • Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance;
  • Concomitant use of other anti-diabetic medication (such as metformin); use of a short-acting insulin will not be considered an exclusion;
  • Known or suspected fetal anomaly or aneuploidy;
  • Prisoners;
  • Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.
Eastern Virginia Medical School logoEastern Virginia Medical School
연구 책임자
Marwan Ma'ayeh, 책임연구자, Assistant Professor, Eastern Virginia Medical School
연구 대표 연락처
연락처: Marwan Ma'ayeh, MD, 7574467900, [email protected]
1 1개국에 임상시험 장소

Virginia

Sentara Norfolk General Hospital, Norfolk, Virginia 23507, Norfolk, Virginia, 23507, United States
Marwan Ma'ayeh, 연락처, 7574467900, [email protected]