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Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management IV期 200 孕期

尚未招募
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07224893旨在研究治疗，主要针对妊娠前糖尿病，妊娠。这是一项IV期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年12月1日开始，预计招募200名患者。该研究由Eastern Virginia Medical School主导，计划于2027年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月5日。
简要概括
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...显示更多
官方标题

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

疾病
妊娠前糖尿病妊娠
出版物
关于此临床试验发表的科学文章和研究论文：
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其他研究标识符
  • 25-09-FB-0214
NCT编号
NCT07224893
实际开始日期
2025-12-01
最近更新发布
2025-11-05
预计完成日期
2027-12-01
计划入组人数
200
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
尚未招募
关键词
continuous glucose monitoring
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
阳性对照Once-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
实验性Twice-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
主要终点
结果指标度量标准描述时间框架
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
次要终点
结果指标度量标准描述时间框架
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
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
女性
  • 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
研究责任方
Marwan Ma'ayeh, 主要研究者, Assistant Professor, Eastern Virginia Medical School
研究中心联系人
联系人: Marwan Ma'ayeh, MD, 7574467900, [email protected]
1 位于 1 个国家/地区的研究中心

Virginia

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