COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Neonatal hypoglycaemia
研究概览
简要总结
The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.
详细描述
Gestational diabetes mellitus (GDM) is a form of glucose intolerance affecting up to 14% of pregnant women and is associated with an increased risk of multiple maternal and fetal complications. This risk is proportional to the degree of maternal hyperglycaemia. Appropriate glycaemic control and dietary management are key components of GDM treatment. However, in approximately 10-30% of cases, pharmacological therapy is required, due to persistent fasting hyperglycaemia.
Neonatal hypoglycaemia is one of the most common metabolic complications associated with GDM, affecting approximately 5-15% of newborns, and is linked to increased morbidity. There is currently no universal consensus regarding the lowest safe blood glucose threshold required to prevent neurological complications in this population. Nevertheless, persistent or recurrent hypoglycaemia, that is unresponsive to treatment is known to be associated with adverse neurological outcomes.
Following birth and umbilical cord clamping, the newborn must maintain glucose homeostasis through endogenous production via glycogenolysis and gluconeogenesis, as well as through enteral feeding. This physiological transition results in lower blood glucose concentrations during the first 4 hours of life and increases the risk of neonatal hypoglycaemia. Furthermore, in pregnancies complicated by insulin-treated GDM, chronic maternal hyperglycaemia leads to hypertrophy of the fetal pancreatic islets and fetal hyperinsulinaemia, which further increases the risk of hypoglycaemia after birth.
Current clinical guidelines rely on intermittent capillary blood glucose measurements performed at predetermined intervals. However, this scheduled testing approach may fail to detect transient hypoglycaemic episodes.
Continuous glucose monitoring (CGM) enables continuous measurement of interstitial glucose concentrations. Despite its potential advantages, there is limited evidence regarding the clinical significance of CGM use in neonates born to mothers with insulin-treated gestational diabetes.
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
盲法说明
In the control group, CGM data are not visible to the clinical team and do not influence clinical management.
入排标准
- 年龄范围
- 1 Minute 至 30 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maternal age of 18 years or older
- •Singleton pregnancy
- •Insulin-treated gestational diabetes mellitus
排除标准
- •Multifetal pregnancy
- •Congenital malformations or metabolic defects in the newborn
- •Preterm birth (defined as birth <37 weeks of gestation)
- •Smoking during pregnancy
- •Preeclampsia, fetal growth restriction
- •Perinatal asphyxia
- •Congenital infections in the newborn
- •Adverse skin reactions (eczema, wounds) in the planned sensor insertion area
研究组 & 干预措施
Continuous glucose monitoring
Neonates undergo continuous glucose monitoring (CGM), with real-time glucose values visible to the clinical team. CGM data may be used to support the detection and clinical management of neonatal hypoglycaemia in accordance with the study protocol.
干预措施: Dexcom ONE Continuous Glucose Monitoring System (Device)
Blood glucose testing based on standard care procedures
Detection and management of neonatal hypoglycaemia are based on standard care procedures, as defined by the local protocol. Additionally, neonates undergo continuous glucose monitoring (CGM) in masked mode. CGM values are not visible to the clinical team and do not guide clinical decision-making.
干预措施: Dexcom ONE Continuous Glucose Monitoring System (Device)
结局指标
主要结局
Neonatal hypoglycaemia
时间窗: From birth until 72 hours of life
Number of hypoglycaemic episodes per neonate, defined as the number of CGM-recorded glucose values \<40mg/dl (2.2 mmol/L) occuring within the first 72 hours after birth.
次要结局
- Total cumulative duration of hypoglycaemia per neonate within the first 72 hours of life(From birth until 72 hours of life)
- Number of hypoglycaemia-related clinical interventions per neonate during the monitoring period(From birth until 72 hours of life)
- Number of capillary blood glucose measurements per neonate(From birth until 72 hours of life)
- Measures of glucose variability per neonate within the first 72 hours of life(First 72 hours after birth)
- Percentage of time with glucose <40 mg/dL(From birth until 72 hours of life)
- Proportion of neonates by feeding type at hospital discharge(At the time of hospital discharge)
研究者
Dr. Aleksandra Symonides-Pomianek
Resident Physician in Neonatology
Institute of Mother and Child, Warsaw, Poland