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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 110
- Locations
- 5
- Primary Endpoint
- Patient compliance
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Mobile health application
Use of GDM application for GDM management
Intervention: Datos mobile health application (Other)
Control
Regular follow-up without the GDM application
Intervention: Regular follow-up (Other)
Outcomes
Primary Outcomes
Patient compliance
Time Frame: During the follow up in the clinic (around 4 months)
Defined as the actual blood glucose measurements/instructed measurements ×100
Secondary Outcomes
- Induction of labor(At birth)
- Neonatal intensive care unit admission(A week after delivery)
- Neonatal hypocalcemia(During hospitalization after delivery (around the first week))
- Neonatal hypomagnesemia(During hospitalization after delivery (around the first week))
- Percentage of off-target glucose measurements(During the follow up in the clinic (around 4 months))
- Instrumental or cesarean delivery(At birth)
- shoulder dystocia(At birth)
- Neonatal birth weight(At birth)
- Number of neonates who needed phototherapy(During hospitalization after delivery (around the first week))
- Neonatal death(During hospitalization after delivery (around the first week))
- Apgar score(One and Five minutes after birth)
- Patients' satisfaction from the monitoring protocol(Will be evaluated up to 2 months after birth)
- Mean blood glucose of the daily glucose charts(During the follow up in the clinic (around 4 months))
- Preeclampsia/gestational hypertension(During the follow up in the clinic (around 4 months))
- Respiratory morbidity of the newborn(During hospitalization after delivery (around one week))
- polyhydramnios(During the follow up in the clinic (around 4 months))
- Hypoglycemia of the newborn(During hospitalization after delivery (around one week))
- Need for pharmacotherapy for glycemic control(During the follow up in the clinic (around 4 months))
- Third- or fourth-degree perineal tears(At birth)