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

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

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 Overview

• Status: Recruiting
• Conditions: Gestational Diabetes; Pregnancy in Diabetic
• Intervention / Treatment: Other: Datos mobile health application; Other: Regular follow-up

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enav Yefet, MD/PhD; Phone Number: 972-46652306; Email: enyefet@pmc.gov.il

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • Emek Medical Center
    • Contact: Zohar Nachum
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Dana Vitner
  • H̱olon, Israel
    • Not yet recruiting
    • Wolfson Medical Center
    • Contact: Lilia Tamayev
  • Nahariya, Israel
    • Not yet recruiting
    • Galilee Medical Center
    • Contact: Maya Wolf
  • North
    • Tiberias, North, Israel, 15208
      • Recruiting
      • Baruch Padeh Medical center, Poriya
      • Contact: Enav Yefet, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile health application; Use of GDM application for GDM management	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.
Other: Control; Regular follow-up without the GDM application	Other: Regular follow-up; Regular follow-up according to the local clinic protocol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Need for pharmacotherapy for glycemic control		During the follow up in the clinic (around 4 months)
polyhydramnios	At least once	During the follow up in the clinic (around 4 months)
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
Third- or fourth-degree perineal tears		At birth
Neonatal birth weight		At birth
Neonatal intensive care unit admission		A week after delivery
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	According to numeric rating scale (1-least satisfied, 10-most satisfied)	Will be evaluated up to 2 months after birth

Collaborators and Investigators

• Sponsor: The Baruch Padeh Medical Center, Poriya
• Collaborators: Bar-Ilan University, Israel

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Complications; Compliance; Gestational diabetes; Mobile-health application
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 56-22-POR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No