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
The Baruch Padeh Medical Center, Poriya
110 participants
May 18, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Pregnant women diagnosed with GDM from 13.0 gestational week
- Recruitment until 34.0 gestational week
- years old and older
- Singleton pregnancy
Exclusion Criteria4
- Women with pre-gestational diabetes mellitus
- Multiple pregnancy
- Women without a Smartphone that can support the GDM application
- Refusal to participate
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Interventions
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.
Regular follow-up according to the local clinic protocol
Locations(5)
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NCT05648721