Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 58
- 主要终点
- Glycemic Control in pre-pregnant group
研究概览
简要总结
The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose Monitoring) can improve glycemic control in women with T1D who are pregnant or planning pregnancy.
详细描述
In women with diabetes, hyperglycemia is associated with increased rates of numerous maternal and fetal adverse outcomes. Mothers are at increased risk of preeclampsia, polyhydramnios, and caesarean sections. Infants of mothers with diabetes have increased rates of congenital anomalies, premature delivery, macrosomia, stillbirth and NICU admissions. Macrosomia itself is associated with numerous adverse fetal outcomes including shoulder dystocia, birth injury, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress syndrome and NICU admissions, asphyxia and death. Postprandial blood sugars in particular have been associated with increased macrosomia rates.
Numerous studies have shown that pregnancy outcomes can be reduced with improved glycemic control. In particular, pre-pregnancy care has been shown to assist women improve glucose control during the crucial period of organogenesis, and is associated with reduced rates of adverse pregnancy outcome including major congenital malformation, stillbirth and neonatal death.
Technological advances aimed at reducing glycemic excursions and improving glucose control in patients with diabetes include the continuous glucose monitoring (CGM) system. We hypothesize that real-time CGM will assist women with type 1 diabetes to improve their glycemic control before and during pregnancy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
- •Age 18-40 years
- •Insulin regimen involves either the use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day). Subjects using premixed fixed doses of insulin at the time of enrolment will not be eligible. Insulin regimen must be stable for at least 4 weeks (i.e. on multiple insulin injections or on insulin pump) prior to randomization.
- •No expectation that subject will be moving out of the area of the clinical center during the next year, unless the move will be to an area served by another study center
- •Informed Consent Form signed by the subject
- •In addition, specific eligibility criteria apply to the respective groups:
- •Pre-pregnancy Group:
- •Patients who are planning pregnancy and wish to optimise glycemic control before conception
- •Pregnancy Group:
- •Pregnancy gestation ≤13 weeks, 6 days at time of randomization
- •Live singleton fetus
- •Dating ultrasound (US) done to confirm gestational age, viability and rule out multiples. Gestational age will be based on the last menstrual period (LMP) provided there is a ≤5 day discrepancy with US dates in the first trimester and ≤10 day discrepancy with US dates in the second trimester. If the dates from LMP are outside these limits, the US dates will be used as the best estimate of gestational age.
排除标准
- •Type 2 diabetes
- •Gestational diabetes
- •Previous participation in the study
- •Estimated GFR <60 ml/min/1.73
- •The presence of a significant medical disorder or use of a medication such as oral glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- •If the investigator is uncertain whether the patient would be eligible; i.e. if the medical disorder would constitute an exclusion, the Steering Committee will be asked to make the decision.
- •Inpatient psychiatric treatment in the past 6 months
- •Subjects using premixed fixed doses of insulin at the time of enrolment
- •In addition, specific exclusion criteria apply to the respective groups:
- •Pre-pregnancy Group:
- •HbA1c <7.0% or >10.0%
- •Pregnancy Group:
- •HbA1c <6.5% or >10.0%
- •Known current higher order pregnancies (twins, triplets, etc.) These women will be excluded as they have a higher rate of adverse outcomes and could lead to inequalities if they are unequally distributed between the groups.
- •Known potentially major fetal anomaly (as per EUROCAT criteria).
研究组 & 干预措施
HGM
Standard of care, Home Glucose Monitoring
CGM
Continuous Glucose Monitoring
干预措施: CGM (Device)
结局指标
主要结局
Glycemic Control in pre-pregnant group
时间窗: 24 weeks or at conception
Glycemic control as measured by HbA1c at 24 weeks or at conception. If the patient becomes pregnant, than a HbA1c will be measured post-confirmation of a positive pregnancy test and will contribute to the primary outcome.
Glycemic Control in pregnant group
时间窗: 34 weeks gestation
Glycemic control as measured by HbA1c at 34 weeks gestation. In women who do not progress to 34 weeks gestation, the latest measured HbA1c will be used to contribute to the primary outcome.
次要结局
- Time in target in pre-pregnant group(12 and 24 weeks after randomization)
- AUC(At delivery)
- Glucose variability(Up to delivery)
- HbA1c and time in target, in pre-pregnant group who became pregnant within 24 weeks from randomization(24 weeks and 34 weeks gestation)
- HbA1c measurement in pregnant group(24 weeks and 34 weeks gestation)
- Hypertension in pregnant group(Up to 42 weeks gestation)
- Gestational weight gain in pregnant group(Up to 34 weeks gestation)
- Time in target in pregnant group(Randomization, 24 weeks and 34 weeks gestation)
- Caesarean sections in pregnant group(At delivery)
- Incidence of Clinical events(Up to 42 weeks gestation)
- Questionnaires(Baseline and 24 weeks or at confirmed pregnancy (pre-pregnant); Baseline and 34 weeks (pregnant))
- Hospital stay(Admission until hospital discharge)
- Insulin requirements(Pre-pregnant (randomization, 12 weeks, 24 weeks); Pregnant (randomization, 24 weeks and 34 weeks gestation))
- Study Contacts(Up to delivery)
- Infant Outcomes(Until hospital discharge)
- Infant outcomes(Until hospital discharge)