Clinical trial NCT05648721: The Effects of a Digital Application for GDM Management in Improving Patients' Compliance
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Pregnancy in Diabetic
Keywords: Gestational diabetes
Pregnancy
Mobile-health application
Compliance
Complications
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
Collaborators: name: Bar-Ilan University, Israel
First posted: 2022-12-13
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient compliance
timeFrame: During the follow up in the clinic (around 4 months)
Secondary outcomes:
measure: Mean blood glucose of the daily glucose charts
timeFrame: During the follow up in the clinic (around 4 months)
measure: Percentage of off-target glucose measurements
timeFrame: During the follow up in the clinic (around 4 months)
measure: Need for pharmacotherapy for glycemic control
timeFrame: During the follow up in the clinic (around 4 months)
measure: polyhydramnios
timeFrame: During the follow up in the clinic (around 4 months)
measure: Preeclampsia/gestational hypertension
timeFrame: During the follow up in the clinic (around 4 months)
measure: Induction of labor
timeFrame: At birth
measure: Instrumental or cesarean delivery
timeFrame: At birth
measure: shoulder dystocia
timeFrame: At birth
measure: Third- or fourth-degree perineal tears
timeFrame: At birth
measure: Neonatal birth weight
timeFrame: At birth
measure: Neonatal intensive care unit admission
timeFrame: A week after delivery
measure: Hypoglycemia of the newborn
timeFrame: During hospitalization after delivery (around one week)
measure: Respiratory morbidity of the newborn
timeFrame: During hospitalization after delivery (around one week)
measure: Number of neonates who needed phototherapy
timeFrame: During hospitalization after delivery (around the first week)
measure: Neonatal death
timeFrame: During hospitalization after delivery (around the first week)
measure: Neonatal hypocalcemia
timeFrame: During hospitalization after delivery (around the first week)
measure: Neonatal hypomagnesemia
timeFrame: During hospitalization after delivery (around the first week)
measure: Apgar score
timeFrame: One and Five minutes after birth
measure: Patients' satisfaction from the monitoring protocol
timeFrame: Will be evaluated up to 2 months after birth
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Baruch Padeh Medical center, Poriya
state: North
city: Afula
country: Israel
facility: Emek medical center
city: Haifa
country: Israel
facility: Rambam medical center
city: H̱olon
country: Israel
facility: Wolfson medical center
city: Nahariya
country: Israel
facility: Galilee medical center
Study officials:
References: