NCT07224893招募中4 期
Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Weekly Time in Range
研究概览
简要总结
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 study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
- •Known or suspected fetal anomaly or aneuploidy;
- •Prisoners;
- •Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.
研究组 & 干预措施
Once-Daily Insulin Glargine
Active Comparator
Participants randomized to this arm will take insulin glargine once daily
干预措施: Use of insulin glargine once daily (Drug)
Twice-Daily Insulin Glargine
Experimental
Participants randomized to this arm will take insulin glargine twice daily
干预措施: Use of insulin glargine twice daily (Drug)
结局指标
主要结局
Weekly Time in Range
时间窗: From Day 7 to Day 14 after study enrollment
The mean blood glucose time in range as measured by the continuous glucose monitor
次要结局
- Hypertensive disorders of pregnancy(From time of enrollment until time of delivery, up to 20 weeks following enrollment)
- Preterm birth <34 weeks(From time of enrollment to 34 weeks gestation)
- Quantitative blood loss(Duration of labor, up to 24 hours)
- Preterm birth <37 weeks(From time of enrollment until 37 weeks gestation)
- Spontaneous or Indicated Delivery(From time of enrollment until time of delivery, up to 20 weeks following enrollment)
- Operative vaginal delivery(From time of enrollment to time of delivery, up to 20 weeks following enrollment)
- Cesarean Delivery(From time of enrollment to time of delivery, up to 20 weeks following enrollment)
- Estimated blood loss(Duration of labor, up to 24 hours)
- Blood transfusion(From time of enrollment until hospital discharge (up to 42 days post-delivery))
- Endometritis(From time of enrollment to hospital discharge (up to 42 days post-delivery))
- Chorioamnionitis(From time of enrollment until time of hospital discharge (up to 42 days post-delivery))
- Wound infection(From time of enrollment to hospital discharge (up to 42 days post-delivery))
- Venous thromboembolism(From time of enrollment to time of hospital discharge (up to 42 days post-delivery))
- Massive transfusion and postpartum hemorrhage(From time of enrollment until hospital discharge (up to 42 days post-delivery))
- ICU admission(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(From time of enrollment to time of delivery, up to 20 weeks following enrollment)
- Intrapartum death(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(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(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(From time of delivery to time of hospital discharge, up to 1 year following delivery)
- Shoulder dystocia(From time of delivery to time of hospital discharge, up to 1 year following delivery)
- Birth trauma(From time of delivery to time of hospital discharge, up to 1 year following delivery)
- Intracranial hemorrhage(From time of delivery to time of hospital discharge, up to 1 year following delivery)
- Hyperbilirubinemia requiring phototherapy or exchange transfusion(From time of delivery to time of hospital discharge, up to 1 year following delivery)
- NICU admission(From time of delivery to time of hospital discharge, up to 1 year following delivery)
研究者
Marwan Ma'ayeh
Assistant Professor
Eastern Virginia Medical School
研究点 (2)
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