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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gestational Diabetes, Pregnancy in Diabetic

Intervention / Treatment
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* Other: Datos mobile health application
* Other: Regular follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile health application<br>Use of GDM application for GDM management | Other: Datos mobile health application<br>* 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.<br>|
| Other: Control<br>Regular follow-up without the GDM application | Other: Regular follow-up<br>* Regular follow-up according to the local clinic protocol<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes, Pregnancy, Mobile-health application, Compliance, Complications