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NCT05648721
The Effects of a Digital Application for GDM Management in Improving Patients' Compliance
Conditions: Gestational Diabetes, Pregnancy in Diabetic
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 110
Sponsor: The Baruch Padeh Medical Center, Poriya
Location: Israel
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 Criteria
Inclusion Criteria:Pregnant women diagnosed with GDM from 13.0 gestational weekRecruitment until 34.0 gestational week18 years old and olderSingleton pregnancyExclusion Criteria:Women with pre-gestational diabetes mellitusMultiple pregnancyWomen without a Smartphone that can support the GDM applicationRefusal to participate
Source: ClinicalTrials.gov (NCT05648721). StuddyBuddy aggregates publicly available trial information.