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

Primary Purpose

Gestational Diabetes, Pregnancy in Diabetic

Status

Not yet recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Datos mobile health application

Regular follow-up

About this trial

This is an interventional supportive care trial for Gestational Diabetes focused on measuring Gestational diabetes, Pregnancy, Mobile-health application, Compliance, Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Emek medical center
Rambam medical center
Wolfson medical center
Galilee medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mobile health application

Control

Arm Description

Use of GDM application for GDM management

Regular follow-up without the GDM application

Outcomes

Primary Outcome Measures

Patient compliance

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

Secondary Outcome Measures

Mean blood glucose of the daily glucose charts

Percentage of off-target glucose measurements

Need for pharmacotherapy for glycemic control

polyhydramnios

At least once

Preeclampsia/gestational hypertension

Induction of labor

Instrumental or cesarean delivery

shoulder dystocia

Third- or fourth-degree perineal tears

Neonatal birth weight

Neonatal intensive care unit admission

Hypoglycemia of the newborn

Respiratory morbidity of the newborn

Number of neonates who needed phototherapy

Neonatal death

Neonatal hypocalcemia

Neonatal hypomagnesemia

Apgar score

Patients' satisfaction from the monitoring protocol

According to numeric rating scale (1-least satisfied, 10-most satisfied)

Full Information

NCT ID

NCT05648721

First Posted

November 22, 2022

Last Updated

December 12, 2022

Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

Bar-Ilan University, Israel

1. Study Identification

Unique Protocol Identification Number

NCT05648721

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 20, 2022 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

Bar-Ilan University, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes, Pregnancy in Diabetic

Keywords

Gestational diabetes, Pregnancy, Mobile-health application, Compliance, Complications

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mobile health application

Arm Type

Experimental

Arm Description

Use of GDM application for GDM management

Arm Title

Control

Arm Type

Other

Arm Description

Regular follow-up without the GDM application

Intervention Type

Other

Intervention Name(s)

Datos mobile health application

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Regular follow-up

Intervention Description

Regular follow-up according to the local clinic protocol

Primary Outcome Measure Information:

Title

Patient compliance

Description

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

Time Frame