NCT05648721

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: The Baruch Padeh Medical Center, Poriya · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes
• Pregnancy in Diabetic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-18
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2022-12-13
• Last updated: 2024-07-05

Locations

5 sites across 1 country: Israel