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

NCT07158970 | Not Yet Recruiting

• 1 other identifier: 0125-25-WOMC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes Mellitus

Keywords

home ultrasound; telemedicine

Outcome Measures

Primary Outcomes (1)

• 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.

  at 37-39 weeks gestation

Secondary Outcomes (11)

• 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

Study Arms (2)

Home-US Group

EXPERIMENTAL

Home Ultrasound Monitoring

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

Interventions

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

Standard care

Home-US Group

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wolfson Medical Center: lead
• PulseNmore: collaborator

Study Sites (1)

Edith Wolfson Medical Center

H̱olon, Central District, 5834468, Israel

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• LIat Mor

  Edith Wolfson Medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liat Mor

CONTACT

+972546738294; liatmor1@gmail.com

Michal De-Wolf

CONTACT

03-5028346; michald@wmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OBGYN resident

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: September 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)