Gestational Diabetes, Pregnancy in Diabetic
Conditions
Keywords
Gestational diabetes, Pregnancy, Mobile-health application, Compliance, Complications
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.
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
Sponsors
Bar-Ilan University, Israel
The Baruch Padeh Medical Center, Poriya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient compliance | During the follow up in the clinic (around 4 months) | Defined as the actual blood glucose measurements/instructed measurements ×100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal birth weight | At birth | — |
| Neonatal intensive care unit admission | A week after delivery | — |
| Preeclampsia/gestational hypertension | During the follow up in the clinic (around 4 months) | — |
| Induction of labor | At birth | — |
| Instrumental or cesarean delivery | At birth | — |
| shoulder dystocia | At birth | — |
| polyhydramnios | During the follow up in the clinic (around 4 months) | At least once |
| Mean blood glucose of the daily glucose charts | During the follow up in the clinic (around 4 months) | — |
| Percentage of off-target glucose measurements | During the follow up in the clinic (around 4 months) | — |
| Third- or fourth-degree perineal tears | At birth | — |
| Hypoglycemia of the newborn | During hospitalization after delivery (around one week) | — |
| Respiratory morbidity of the newborn | During hospitalization after delivery (around one week) | — |
| Number of neonates who needed phototherapy | During hospitalization after delivery (around the first week) | — |
| Neonatal death | During hospitalization after delivery (around the first week) | — |
| Neonatal hypocalcemia | During hospitalization after delivery (around the first week) | — |
| Neonatal hypomagnesemia | 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 | According to numeric rating scale (1-least satisfied, 10-most satisfied) |
| Need for pharmacotherapy for glycemic control | During the follow up in the clinic (around 4 months) | — |
Countries
Israel
Contacts
Primary ContactEnav Yefet, MD/PhD
Outcome results
None listed