The Effects of a Digital Application for GDM Management in Improving Patients' Compliance

Not Applicable

Recruiting

• Conditions: Pregnancy in Diabetic; Gestational Diabetes
• Interventions: Other: Regular follow-up; Other: Datos mobile health application

• Registration Number: NCT05648721
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-13
• Study Start: 2023-05-18
• Status Verified: 2023-11
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Regular follow-up	Regular follow-up without the GDM application
Mobile health application	Datos mobile health application	Use of GDM application for GDM management

Primary Outcome Measures

Name	Time	Method
Patient compliance	During the follow up in the clinic (around 4 months)	Defined as the actual blood glucose measurements/instructed measurements ×100

Secondary Outcome Measures

Name	Time	Method
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	According to numeric rating scale (1-least satisfied, 10-most satisfied)
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)	At least once
Hypoglycemia of the newborn	During hospitalization after delivery (around one week)
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)
Need for pharmacotherapy for glycemic control	During the follow up in the clinic (around 4 months)
Third- or fourth-degree perineal tears	At birth

Trial Locations

Locations (5)

Emek medical center; 🇮🇱 Afula, Israel

Baruch Padeh Medical center, Poriya; 🇮🇱 Tiberias, North, Israel

Rambam medical center; 🇮🇱 Haifa, Israel

Galilee medical center; 🇮🇱 Nahariya, Israel

Wolfson medical center; 🇮🇱 H̱olon, Israel