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

Gestational Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648721
• Other study ID #: 56-22-POR
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Enav Yefet, MD/PhD
• Phone: 972-46652306
• Email: enyefet[@]pmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy in Diabetic
• Pregnancy in Diabetics

Intervention

Other:
• Datos 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.
• Regular follow-up
Regular follow-up according to the local clinic protocol

Locations

Country	Name	City	State
Israel	Emek medical center	Afula
Israel	Wolfson medical center	H_olon
Israel	Rambam medical center	Haifa
Israel	Galilee medical center	Nahariya
Israel	Baruch Padeh Medical center, Poriya	Tiberias	North

Sponsors (2)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya	Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient compliance	Defined as the actual blood glucose measurements/instructed measurements ×100	During the follow up in the clinic (around 4 months)
Secondary	Mean blood glucose of the daily glucose charts		During the follow up in the clinic (around 4 months)
Secondary	Percentage of off-target glucose measurements		During the follow up in the clinic (around 4 months)
Secondary	Need for pharmacotherapy for glycemic control		During the follow up in the clinic (around 4 months)
Secondary	polyhydramnios	At least once	During the follow up in the clinic (around 4 months)
Secondary	Preeclampsia/gestational hypertension		During the follow up in the clinic (around 4 months)
Secondary	Induction of labor		At birth
Secondary	Instrumental or cesarean delivery		At birth
Secondary	shoulder dystocia		At birth
Secondary	Third- or fourth-degree perineal tears		At birth
Secondary	Neonatal birth weight		At birth
Secondary	Neonatal intensive care unit admission		A week after delivery
Secondary	Hypoglycemia of the newborn		During hospitalization after delivery (around one week)
Secondary	Respiratory morbidity of the newborn		During hospitalization after delivery (around one week)
Secondary	Number of neonates who needed phototherapy		During hospitalization after delivery (around the first week)
Secondary	Neonatal death		During hospitalization after delivery (around the first week)
Secondary	Neonatal hypocalcemia		During hospitalization after delivery (around the first week)
Secondary	Neonatal hypomagnesemia		During hospitalization after delivery (around the first week)
Secondary	Apgar score		One and Five minutes after birth
Secondary	Patients' satisfaction from the monitoring protocol	According to numeric rating scale (1-least satisfied, 10-most satisfied)	Will be evaluated up to 2 months after birth