Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 386
- 试验地点
- 24
- 主要终点
- a composite of pregnancy outcomes
研究概览
简要总结
There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian-Australian open-label multi-centric RCT with 16 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3 +) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.
详细描述
At diagnosis of GDM, women will receive education on the management of GDM with lifestyle and need to monitor glucose with SMBG. Within one week of GDM diagnosis, all participants will be asked to use a blinded CGM (Freestyle Libre Pro IQ,) during a run-phase. Women randomized to the control arm, will be asked to intermittently wear a blinded CGM sensor (Freestyle Libre Pro IQ) during 14 days at least two time points in pregnancy (at 31.0-33.6 weeks and between 36.0-38.6 weeks). For women diagnosed with early GDM (<20 weeks), blinded CGM will be needed 3 times in pregnancy with a first time at 20.0-23.9 weeks. Women randomized to the intervention arm will be recommended tu use the rt-CGM (Freestyle Libre 3) till the delivery. In line with normal routine, a 75g OGTT will be performed between 6-24 weeks postpartum to screen for glucose intolerance. Participants will be asked to also wear a blinded CGM (Freestyle Libre Pro IQ) at this last study visit.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- •Singleton pregnancy
- •Diagnosed with gestational diabetes before 29.6 weeks of pregnancy
- •Needs to be able to understand and speak Dutch, French or English.
- •Have email access
排除标准
- •Patient has a history of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes
- •A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician).
- •Use of medication with significant impact on glycemia (such as high dose glucocorticoids and diabetes medication such as metformin)
- •Participation in an interventional Trial with an investigational medicinal product or device
- •Multiple pregnancy
- •History of bariatric surgery
- •Known allergy to the adhesives used with the continuous glucose monitoring
研究组 & 干预措施
continuous glucose monitoring
continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3
干预措施: Freestyle Libre 3 (Device)
self monitoring of blood glucose with glucometer
self monitoring of blood glucose with glucometer, at least 2 days per week if treated with lifestyle and daily if additional treatment with insulin is started
干预措施: Glucometer (Device)
结局指标
主要结局
a composite of pregnancy outcomes
时间窗: at delivery
Hence, the primary outcome is a binary variable, taking the value 1 if at least one of the adverse pregnancy outcomes occurs, or zero otherwise:preterm delivery \<37 weeks, large-for-gestational age infant, neonatal hypoglycaemia, (requiring intravenous dextrose), NICU admission (\>24h), respiratory distress (at least 4 hours of respiratory support with supplemental oxygen, CPAP, or intermittent positive-pressure ventilation during the first 24 hours after delivery), stillbirth or neonatal death, phototherapy for jaundice, birth trauma and shoulder dystocia
次要结局
- rate of postpartum hemorrhage(at delivery)
- rate of baby >4.5Kg(at delivery)
- rate of Small-for-gestational age infant(at delivery)
- rate of gestational hypertension(at delivery)
- Treatment satisfaction(between 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum)
- dietary intake(baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum)
- fear for hypoglycaemia(between 36.0-38.6 weeks)
- time in glucose range overnight between 70-95mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- time in glucose range during the day between 70-95mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- time in glucoserange during the day between 63-140mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- hypoglycemia <54mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- Coefficient of Variance(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- glucose time overnight >100mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- day glucose time in range <70mg/dl(postpartum between 6-24 weeks)
- glucose postprandial time >140mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- time in glucose range overnight between 63-140mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation)
- time in glucose range overnight between 54-95mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- hypoglycemia <63mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- hypoglycemia <70mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- mean HbA1c(between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum)
- rate of cesarean section(at delivery)
- rate of instrumental delivery(at delivery)
- rate of labor inductions(at delivery)
- rate of polycythemia(at delivery)
- Physical activity(baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum)
- symptoms of anxiety(baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum)
- duration of breastfeeding(postpartum between 6-24 weeks)
- rate of hypercholesterolemia(postpartum between 6-24 weeks)
- night glucose time in range between 70-180mg/dl(postpartum between 6-24 weeks)
- night glucose time in range <70mg/dl(postpartum between 6-24 weeks)
- hypoglycemia <50mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- standard deviation(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- glucose postprandial time >120mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- glucose time >180mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- Glucose management indicator(between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum)
- rate of macrosomia(at delivery)
- rate of perineal inury(at delivery)
- rate of neonatal hypoglycemia(at delivery)
- mean amplitude of glycemic excursions(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- mean insulin dose(from GDM diagnosis till delivery)
- timing of start insulin treatment(from GDM diagnosis till delivery)
- mean gestational weight gain(at delivery)
- rate of preeclamspia(at delivery)
- rate of fetal malformation(at delivery)
- rate of miscarriage(at delivery)
- Quality of life based on Short Form (SF-36) score(baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum)
- fear for hyperglycaemia(between 36.0-38.6 weeks)
- symptoms of depression(baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum)
- user-friendliness of CGM(between 36.0-38.6 weeks)
- day glucose time in range between 70-180mg/dl(postpartum between 6-24 weeks)
- night glucose time in range >180mg/dl(postpartum between 6-24 weeks)
- day glucose time in range >180mg/dl(postpartum between 6-24 weeks)
- time in glucose range during the day between 54-95mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- time in glucose range overnight between 63-120mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- time in glucose range during the day between 63-120mg/dl(during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks)
- user-friendliness of CGM compared to oral glucose tolerance test (OGTT)(between 6-24 weeks postpartum)