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| Name | Class |
|---|---|
| Bar-Ilan University, Israel | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile health application | Experimental | Use of GDM application for GDM management |
|
| Control | Other | Regular follow-up without the GDM application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Datos mobile health application | Other | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enav Yefet, MD/PhD | Contact | 972-46652306 | enyefet@pmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baruch Padeh Medical center, Poriya | Recruiting | Tiberias | North | 15208 | Israel |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011254 | Pregnancy in Diabetics |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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|
| Regular follow-up | Other | Regular follow-up according to the local clinic protocol |
|
| 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 |
| Emek medical center | Recruiting | Afula | Israel |
|
| Rambam medical center | Recruiting | Haifa | Israel |
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| Wolfson medical center | Not yet recruiting | Holon | Israel |
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| Galilee medical center | Not yet recruiting | Nahariya | Israel |
|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |