Effect of Home Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Patient satisfaction
研究概览
简要总结
This study evaluates the impact of incorporating home-ultrasound (home-US) devices into telemedicine care for patients with gestational diabetes mellitus (GDM). The study will compare satisfaction, clinical outcomes, and healthcare costs between standard high-risk pregnancy care and care augmented by home-US.
详细描述
Gestational diabetes mellitus (GDM) requires frequent follow-up to monitor maternal and fetal well-being. While telemedicine improves access and patient satisfaction, it lacks a fetal assessment component. This single-center randomized controlled trial evaluates the integration of home ultrasound (home-US) into telemedicine care for women with GDM.
Participants will be randomized to standard care or an intervention group receiving alternating in-person and telemedicine visits with physician-guided home-US using the Pulsenmore device. The primary outcome is patient satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at term. Secondary outcomes include glycemic control, maternal and neonatal outcomes, healthcare utilization, visit duration, and follow-up costs.
The study will enroll 90 women, aged 18-51, with singleton pregnancies and GDM. The study is conducted at the Edith Wolfson Medical Center in Israel over a one-year period. The home-US device is approved for obstetric use and will be used under real-time physician supervision.
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 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •GDM diagnosed by OGTT or glucose monitoring
- •Hebrew speaking
- •Compatible cellphone
排除标准
- •Pregestational diabetes
- •Fetal anomalies/genetic abnormalities
- •Multifetal pregnancy
- •Late GDM diagnosis (after 34 weeks)
研究组 & 干预措施
Home-US Group
Home Ultrasound Monitoring
干预措施: Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician. (Device)
Standard Care Group
Standard high-risk follow up in clinic
结局指标
主要结局
Patient satisfaction
时间窗: at 37-39 weeks gestation
Assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). It is composed of eight questions, each of which is scored by patients on a scale ranging from zero ("very dissatisfied", "very inconvenient") to six (e.g., "very satisfied", "very convenient"). The questionnaire is composed of two different factors- the first 6 questions assess treatment satisfaction and the last 2 questions assess burden of hyper or hypo-glycemia. the sum of the first 6 points (maximum 36 points) score the treatment satisfaction, with a higher score indicating higher treatment satisfaction.
次要结局
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score(From enrollment (~24-28 weeks) to 37-39 weeks gestation.)
- Glycemic Control(From enrollment to delivery.)
- Clinician Satisfaction(At the end of study participation for each patient (between 37-39 weeks gestation).)
- Mode of Delivery(At time of delivery.)
- Neonatal birth-weight(At time of delivery)
- Estimated Patient Follow-up Costs(At 37-39 weeks gestation.)
- Estimated Institutional Follow-up Costs(From enrollment to delivery.)
- Visit Duration(Through study completion, an average of 1 year (from enrollment to delivery for each participant))
- Unscheduled Emergency Department Visits(From enrollment to 6 weeks postpartum, confirmed by patient interview and EMR.)
- Gestational age at birth(collected after birth from data system)
- Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)(Within the first 28 days of life)
研究者
Liat Mor
OBGYN resident
Wolfson Medical Center