Gestational Diabetes MellitusNCT07158970
Home-Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus (GDM)
A study testing Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician. in people with Gestational Diabetes Mellitus, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- GDM diagnosed by OGTT or glucose monitoring
- Hebrew speaking
- Compatible cellphone
Who cannot join
- Pregestational diabetes
- Fetal anomalies/genetic abnormalities
- Multifetal pregnancy
- Late GDM diagnosis (after 34 weeks)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Edith Wolfson Medical Center
H̱olon, Central District, 5834468
Liat Mor, 0546738294, liatmor1@gmail.com
About this study
Official title: Effect of Home Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.
- Keywords
- home ultrasound, telemedicine
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.Device
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Home-US Group | Experimental | Home Ultrasound Monitoring Receives: Device: Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician. |
| Standard Care Group | No intervention | Standard high-risk follow up in clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
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.
Measured: at 37-39 weeks gestation
Secondary outcomes (11)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
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.
Measured: From enrollment (~24-28 weeks) to 37-39 weeks gestation.
Glycemic Control
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.
Measured: From enrollment to delivery.
Clinician Satisfaction
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.
Measured: At the end of study participation for each patient (between 37-39 weeks gestation).
Mode of Delivery
Evaluation of mode of delivery (vaginal, cesarean)
Measured: At time of delivery.
Neonatal birth-weight
Birth weight
Measured: At time of delivery
Estimated Patient Follow-up Costs
Estimated costs incurred by patients for follow-up (including travel, parking, time off work), collected via structured questionnaire.
Measured: At 37-39 weeks gestation.
Estimated Institutional Follow-up Costs
Estimated resource and time costs for the healthcare system based on visit type (in-person vs. telemedicine), calculated per patient.
Measured: From enrollment to delivery.
Visit Duration
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.
Measured: Through study completion, an average of 1 year (from enrollment to delivery for each participant)
Unscheduled Emergency Department Visits
Number and reason for unscheduled emergency room visits related to pregnancy or GDM during the study period.
Measured: From enrollment to 6 weeks postpartum, confirmed by patient interview and EMR.
Gestational age at birth
Gestational age at birth
Measured: collected after birth from data system
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
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.
Measured: Within the first 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Mar 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Collaborators
- PulseNmore
- Responsible party
- Principal investigator, Liat Mor, Wolfson Medical Center
- Investigators
- LIat Mor, Principal investigator, Edith Wolfson Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158970
- Sponsor's protocol ID
- 0125-25-WOMC
- Status last verified
- Sep 2025
- First submitted
- 14 Jul 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07158970
- Acronym / sponsor ID
- 0125-25-WOMC
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- home ultrasound, telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Collaborators
- PulseNmore
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-US Group | Experimental | Device: Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.Home Ultrasound Monitoring |
| Standard Care Group | No intervention | –Standard high-risk follow up in clinic |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton pregnancy
- GDM diagnosed by OGTT or glucose monitoring
- Hebrew speaking
- Compatible cellphone
Key exclusion criteria (4 listed)
- Pregestational diabetes
- Fetal anomalies/genetic abnormalities
- Multifetal pregnancy
- Late GDM diagnosis (after 34 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.Standard care | Device | Home-US Group |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LIat Mor principal investigator
Edith Wolfson Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician. in people with Gestational Diabetes Mellitus, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liat Mor (+972546738294, liatmor1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: at 37-39 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.