Home-Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus (GDM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician..
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus. Basic parameters: 18 years — 51 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Home Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus
Overview
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.
Detailed 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.
Interventions
- Device Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.
Standard care
Primary outcome measures
- Patient satisfaction [Time frame: at 37-39 weeks gestation]
Secondary outcome measures (11)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score [Time frame: From enrollment (~24-28 weeks) to 37-39 weeks gestation.]
- Glycemic Control [Time frame: From enrollment to delivery.]
- Clinician Satisfaction [Time frame: At the end of study participation for each patient (between 37-39 weeks gestation).]
- Mode of Delivery [Time frame: At time of delivery.]
- Neonatal birth-weight [Time frame: At time of delivery]
- Estimated Patient Follow-up Costs [Time frame: At 37-39 weeks gestation.]
- Estimated Institutional Follow-up Costs [Time frame: From enrollment to delivery.]
- Visit Duration [Time frame: Through study completion, an average of 1 year (from enrollment to delivery for each participant)]
- Unscheduled Emergency Department Visits [Time frame: From enrollment to 6 weeks postpartum, confirmed by patient interview and EMR.]
- Gestational age at birth [Time frame: collected after birth from data system]
- Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU) [Time frame: Within the first 28 days of life]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Edith Wolfson Medical Center — H̱olon
Identifiers
NCT: NCT07158970 · 0125-25-WOMC