RecruitingNot ApplicableNCT05648721

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


Sponsor

The Baruch Padeh Medical Center, Poriya

Enrollment

110 participants

Start Date

May 18, 2023

Study Type

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

Sex: FEMALEMin Age: 18 Years

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

OTHERDatos 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.

OTHERRegular follow-up

Regular follow-up according to the local clinic protocol


Locations(5)

Baruch Padeh Medical center, Poriya

Tiberias, North, Israel

Emek medical center

Afula, Israel

Rambam medical center

Haifa, Israel

Wolfson medical center

Holon, Israel

Galilee medical center

Nahariya, Israel

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NCT05648721


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