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.
Singleton pregnancy
GDM diagnosed by OGTT or glucose monitoring
Hebrew speaking
Compatible cellphone
Pregestational diabetes
Fetal anomalies/genetic abnormalities
Multifetal pregnancy
Late GDM diagnosis (after 34 weeks)
Parallel
Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.
DeviceStandard care
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.
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.
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.
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.
Mode of Delivery
Evaluation of mode of delivery (vaginal, cesarean)
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Wolfson Medical Center
Lead sponsor
PulseNmore
Collaborator
