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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Pregnant women diagnosed with GDM from 13.0 gestational week

• Recruitment until 34.0 gestational week

• 18 years old and older

• Singleton pregnancy

Locations
Other Locations
Israel
Emek medical center
RECRUITING
Afula
Rambam medical center
RECRUITING
Haifa
Wolfson medical center
NOT_YET_RECRUITING
Holon
Galilee medical center
NOT_YET_RECRUITING
Nahariya
Baruch Padeh Medical center, Poriya
RECRUITING
Tiberias
Contact Information
Primary
Enav Yefet, MD/PhD
enyefet@pmc.gov.il
972-46652306
Time Frame
Start Date: 2023-05-18
Estimated Completion Date: 2026-04
Participants
Target number of participants: 110
Treatments
Experimental: Mobile health application
Use of GDM application for GDM management
Other: Control
Regular follow-up without the GDM application
Related Therapeutic Areas
Sponsors
Collaborators: Bar-Ilan University, Israel
Leads: The Baruch Padeh Medical Center, Poriya

This content was sourced from clinicaltrials.gov