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

Baruch Padeh Medical Center

Status: Enrolling

Conditions: Gestational Diabetes; Pregnancy in Diabetic

Treatments: Other: Regular follow-up; Other: Datos mobile health application

Study type: Interventional

Funder types: Other

Identifiers

NCT05648721

56-22-POR

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women diagnosed with GDM from 13.0 gestational week
• Recruitment until 34.0 gestational week
• 18 years old and older
• Singleton pregnancy

Exclusion criteria

• Women with pre-gestational diabetes mellitus
• Multiple pregnancy
• Women without a Smartphone that can support the GDM application
• Refusal to participate

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Mobile health application

Experimental group

Description:

Use of GDM application for GDM management

Treatment:

Other: Datos mobile health application

Control

Other group

Description:

Regular follow-up without the GDM application

Treatment:

Other: Regular follow-up