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RECRUITING
NCT05648721
NA

The Effects of a Digital Application for GDM Management in Improving Patients' Compliance

Sponsor: The Baruch Padeh Medical Center, Poriya

View on ClinicalTrials.gov

Summary

Gestational diabetes mellitus (GDM) is the most prevalent complication in pregnancy. Patients' follow-up and treatment is performed in specialized GDM clinics that teach and support women in implementing lifestyle changes, blood glucose self-monitoring, and nutritional and pharmacologic therapy. Recently, mobile health (mHealth) applications have been introduced as a resource to improve self-management and follow-up among pregnant women. The proposed study will examine the efficacy of the GDM management mHealth application in improving patients' compliance and satisfaction, glycemic control, and pregnancy outcomes. A multicenter randomized controlled trial of women with GDM treated in the GDM clinics. Women will be randomly allocated to a research group that will use the GDM application and a control group that will receive regular follow-up without the GDM application. The primary outcome is patient compliance, defined as the actual blood glucose measurements/instructed measurements ×100. Secondary outcomes include glycemic control parameters, and maternal and neonatal complications.

Official title: The Effects of a Digital Application for Gestational Diabetes Management in Improving Patients' Compliance and Satisfaction, Glycemic Control and Pregnancy Outcomes: A Multicenter Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2023-05-18

Completion Date

2026-04

Last Updated

2024-07-05

Healthy Volunteers

No

Interventions

OTHER

Datos mobile health application

The mobile Health application will send women reminders to perform glucose tests and test results will be sent to the clinic personnel for evaluation. The clinic personnel will receive an alert if a woman does not send glucose charts or when there is an abnormality in the test results. In addition, women will be able to communicate with the clinic's personnel via chat, messages, phone calls, and video.

OTHER

Regular follow-up

Regular follow-up according to the local clinic protocol

Locations (5)

Baruch Padeh Medical center, Poriya

Tiberias, North, Israel

Emek medical center

Afula, Israel

Rambam medical center

Haifa, Israel

Wolfson medical center

Holon, Israel

Galilee medical center

Nahariya, Israel