Home-Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus (GDM)

Wolfson Medical Center (WMC)

Status: Not yet enrolling

Conditions: Gestational Diabetes Mellitus

Treatments: Device: Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07158970

0125-25-WOMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Singleton pregnancy
• GDM diagnosed by OGTT or glucose monitoring
• Hebrew speaking
• Compatible cellphone

Exclusion criteria

• Pregestational diabetes
• Fetal anomalies/genetic abnormalities
• Multifetal pregnancy
• Late GDM diagnosis (after 34 weeks)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Home-US Group

Experimental group

Description:

Home Ultrasound Monitoring

Treatment:

Device: Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.

Standard Care Group

No Intervention group

Description:

Standard high-risk follow up in clinic