A Novel Device for Gestational Diabetes Control, a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- To evaluate the average change in blood glucose levels with the use the Lumen device
研究概览
简要总结
Rationale of the study: Gestational diabetes mellitus (GDM) is very common and the rate of women suffering from it expected to increase in the next years. It is associated with maternal and fetal morbidity and the risk is correlated to the patient's degree of glucose control which can be achieved through a change in lifestyle or medication. Several studies have demonstrated the effectiveness of mobile apps in improving obstetric outcomes in GDM. In addition, the LUMEN device is a breathing device that produces dietary and exercise recommendations based on CO2 levels and improves metabolic parameters in patients with type 2 diabetes. No work has been done on its effectiveness in treating GDM. Aims of the study: Comparison of metabolic outcomes in women with gestational diabetes, with or without the use of LUMEN app. Design: This will be an open label parallel group 1:1 randomized-controlled trial Methods: the investigators will recruit women diagnosed with GDM. The women will be randomized to the intervention arm that will use the LUMEN device and app or to the control arm that will use a free mobile tracking app. The women will be required to monitor their blood sugar levels daily and to have GDM follow-up in the feto-maternal outpatient clinic, as is customary in GDM. After the birth, the maternal and neonatal outcome will be recorded. Based on past research data, a recruitment of 170 is needed to demonstrate a 16.7% decrease in insulin use to balance diabetes, with α = 0.05 and β = 80.
详细描述
Objective The aim of the study is to examine the effect of using Lumen on metabolic parameters and anthropometric variables in patients with gestational diabetes mellitus. Aims and hypotheses Primary aim: To evaluate the rate of progression from GDM-A1 to GDM-A2 between the groups.
Secondary aim: To evaluate the efficacy of Lumen on metabolic parameters, obstetric outcomes, and neonatal outcomes. Hypothesis: the investigators expect that using Lumen would reduce the rate of progression from GDM-A1 to GDM- A2. Methods Design This will be an open label parallel group 1:1 randomized-controlled trial. Participants The study will include up to 170 women diagnosed with GDM. GDM will be defined according to current ACOG (The American College of Obstetricians and Gynecologists) guidelines. A positive glucose challenge test at 24-28 weeks' gestation followed by at least two pathological values in oral glucose challenge or one pathological value and at least one additional risk factor for GDM (a first family member diagnosed with type 2 DM, obesity, history of GDM).
Women in both groups it will use a glucometer and will be instructed in the use of the device. Use will include puncture of the fingertip to obtain a drop of blood and use of a suitable probe to obtain a sugar measurement.
Eligibility criteria
Inclusion criteria:
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gravidas aged 18-45 years
- •Singleton pregnancy
- •Diagnosed with GDM in current pregnancy
- •First visit to high-risk pregnancy clinic is no late than 32 weeks' gestation
- •Not treated with diabetes-related medications
排除标准
- •Medications:
- •Insulin and medications for glycemic control
- •Antipsychotics
- •Corticosteroids
- •Oncologic treatment
- •Conditions:
- •Previous diagnosis of diabetes
- •Renal disease
- •Hepatic disease
- •Personal requirements:
- •Inability to read and understand English
- •Inability to use a smartphone
- •Any issues arise with using the Lumen device and application
- •Aerobic exercise > 3 times per week
结局指标
主要结局
To evaluate the average change in blood glucose levels with the use the Lumen device
时间窗: From date of randomization until the date delivery, assessed up to 4 months
The blood glucose levels will be recorded and the average levels will be compared between the groups
次要结局
- to compare the rate of family history of DM(From date of randomization until the date delivery, assessed up to 4 months)
- to compare the rate of of preeclampsia or gestational hypertension(From date of randomization until the date delivery, assessed up to 4 months)
- To evaluate the change in neonatal length of stay(from the date of delivery and up to 1 month from delivery)
- to compare the parity between the groups(From date of randomization until the date delivery, assessed up to 4 months)
- to compare smoking status(From date of randomization until the date delivery, assessed up to 4 months)
- to compare baseline fertility characteristics(From date of randomization until the date delivery, assessed up to 4 months)
- to compare baseline educational status(From date of randomization until the date delivery, assessed up to 4 months)
- To compare the rate of episiotomy(At the date of delivery)
- To evaluate the change in neonatal death rate(from the date of delivery and up to 1 month from delivery)
- To evaluate the change in need for phototherapy(from the date of delivery and up to 1 month from delivery)
- To evaluate the change in need for neonatal intensive care unit (NICU) admission(from the date of delivery and up to 1 month from delivery)
- to compare the maternal age(From date of randomization until the date delivery, assessed up to 4 months)
- to compare the gestational age at delivery(From date of randomization until the date delivery, assessed up to 4 months)
- to compare the level of physical activity(at the date of randomization)
- to compare baseline body mass index between the groups(at the date of randomization)
- To compare the Gestational age at delivery(at the date if delivery)
- To evaluate the change in respiratory morbidity(from the date of delivery and up to 1 month from delivery)
- to compare the rate of chronic hypertension(From date of randomization until the date delivery, assessed up to 4 months)
- to compare baseline metabolic parameters(From date of randomization until the date delivery, assessed up to 4 months)
- to compare the mode of onset of labor(at the date if delivery)
- to compare the rate of polyhydramnios(From date of randomization until the date delivery, assessed up to 4 months)
- To evaluate the efficacy of Lumen on shoulder dystocia rate(At the date of delivery)
- To evaluate the change it the rate of obstetric anal sphincter injuries(At the date of delivery)
- To evaluate the change in birthweight(At the date of delivery)
- To compare the rate of antenatal corticosteroids administration(From date of randomization until the date delivery, assessed up to 4 months)
- To evaluate the efficacy of Lumen on mode of delivery(At the date of delivery)
- To evaluate the change in hypoglycemia of the newborn(from the date of delivery and up to 1 month from delivery)