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

Recruiting
18 years of age
Female
Phase N/A

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Overview

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

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

Study details

Gestational Diabetes, Pregnancy in Diabetic

NCT05648721

The Baruch Padeh Medical Center, Poriya

25 January 2024

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