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NCT Number: NCT07158970

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

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.

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Key information

Age range

18 year–51 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Edith Wolfson Medical Center

H̱olon, Central District, 5834468, Israel

Location status: Recruiting

Location contact

Liat Mor

CONTACT

[email protected]

0546738294

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Device

Standard care

Primary outcomes

  1. Patient satisfaction

    Time frame: 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.

Secondary outcomes

  1. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score

    Time frame: From enrollment (~24-28 weeks) to 37-39 weeks gestation.

    Difference in patient satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) between early pregnancy (after first visit) and late pregnancy (37-39 weeks gestation).

    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.

  2. Glycemic Control

    Time frame: From enrollment to delivery.

    Assessment of maternal glycemic control based on percent of abnormal glucose values during follow-up (via glucose log or continuous glucose monitoring where available), as recorded by treating physician.

  3. Clinician Satisfaction

    Time frame: At the end of study participation for each patient (between 37-39 weeks gestation).

    Clinician satisfaction will be assessed using a structured questionnaire developed for this study. Physicians will rate various aspects of the telemedicine or in-person follow-up experience, including:

    Ease of use

    Clinical value

    Workflow and efficiency

    Communication and patient engagement

    Technical issues and support

    Each domain will be rated on a 10-point numeric rating scale (0-10), where:

    0 = Not satisfied at all

    10 = Extremely satisfied

    Higher scores indicate greater satisfaction.

  4. Mode of Delivery

    Time frame: At time of delivery.

    Evaluation of mode of delivery (vaginal, cesarean)

  5. Neonatal birth-weight

    Time frame: At time of delivery

    Birth weight

  6. Estimated Patient Follow-up Costs

    Time frame: At 37-39 weeks gestation.

    Estimated costs incurred by patients for follow-up (including travel, parking, time off work), collected via structured questionnaire.

  7. Estimated Institutional Follow-up Costs

    Time frame: From enrollment to delivery.

    Estimated resource and time costs for the healthcare system based on visit type (in-person vs. telemedicine), calculated per patient.

  8. Visit Duration

    Time frame: Through study completion, an average of 1 year (from enrollment to delivery for each participant)

    Duration of each visit, separately recorded for patient time and physician Duration of each clinical visit will be recorded in minutes for both the patient and the physician. This includes both in-person and telemedicine encounters. Separate timing will be documented for:

    Patient time (including waiting and consultation)

    Physician time (active interaction and documentation)

    These data will be used to compare time efficiency between the two care models.

  9. Unscheduled Emergency Department Visits

    Time frame: From enrollment to 6 weeks postpartum, confirmed by patient interview and EMR.

    Number and reason for unscheduled emergency room visits related to pregnancy or GDM during the study period.

  10. Gestational age at birth

    Time frame: collected after birth from data system

    Gestational age at birth

  11. Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)

    Time frame: Within the first 28 days of life

    The number of neonates requiring admission to the neonatal intensive care unit (NICU) following delivery will be recorded and reported. This will be used as an indicator of neonatal morbidity.

Study contacts

Contact information is provided by the study sponsor or research team.

Liat Mor

CONTACT

[email protected]

+972546738294

Michal De-Wolf

CONTACT

[email protected]

03-5028346

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Collaborators

  • PulseNmore

Registry information

Official study title

Effect of Home Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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