NCT05648721

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

May 18, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 5, 2024

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

November 22, 2022

Last Update Submit

July 4, 2024

Conditions

Gestational DiabetesPregnancy in Diabetic

Keywords

Gestational diabetesPregnancyMobile-health applicationComplianceComplications

Outcome Measures

Primary Outcomes (1)

  • Patient compliance

    Defined as the actual blood glucose measurements/instructed measurements ×100

    During the follow up in the clinic (around 4 months)

Secondary Outcomes (19)

  • 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

    During the follow up in the clinic (around 4 months)

  • Preeclampsia/gestational hypertension

    During the follow up in the clinic (around 4 months)

  • +14 more secondary outcomes

Study Arms (2)

Mobile health application

EXPERIMENTAL

Use of GDM application for GDM management

Other: Datos mobile health application

Control

OTHER

Regular follow-up without the GDM application

Other: Regular follow-up

Interventions

Datos mobile health applicationOTHER

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.

Mobile health application
Regular follow-upOTHER

Regular follow-up according to the local clinic protocol

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women diagnosed with GDM from 13.0 gestational week
  • Recruitment until 34.0 gestational week
  • years old and older
  • Singleton pregnancy

You may not qualify if:

  • Women with pre-gestational diabetes mellitus
  • Multiple pregnancy
  • Women without a Smartphone that can support the GDM application
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Baruch Padeh Medical center, Poriya

Tiberias, North, 15208, Israel

RECRUITING

Emek medical center

Afula, Israel

RECRUITING

Rambam medical center

Haifa, Israel

RECRUITING

Wolfson medical center

Holon, Israel

NOT YET RECRUITING

Galilee medical center

Nahariya, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes, GestationalPregnancy in DiabeticsPatient Compliance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Enav Yefet, MD/PhD

CONTACT

972-46652306enyefet@pmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 13, 2022

Study Start

May 18, 2023

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

July 5, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(5)