Group and Mobile Care for Gestational Diabetes

Not Applicable

Completed

• Conditions: Gestational Diabetes
• Interventions: Other: GlucoseMama application with blood sugar monitoring and carb monitoring.; Other: Group prenatal care for GDM.

• Registration Number: NCT03026218
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

A critical variation in the provision of prenatal care to women with GDM is the need to keep patients engaged with their care between visits by tracking glucose levels using finger sticks and making dietary and other lifestyle modifications to keep these levels at or close to normal. Multiple studies have demonstrated that the use of mobile devices can improve medical outcomes. In order to keep patients engaged between appointments and improve self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give the user positive feedback and rewards for using the system. This model of group care with mobile phone monitoring and reminders for women with GDM has not been previously studied. A randomized control trial is purposed to determine if this approach improves patient care. The investigators hypothesize that group prenatal care along with inter-session mobile therapy will increase dietary compliance and therefore reduce the number of individuals requiring pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care (GPC) will provide a community foundation to improve learning and increase the motivation of patients to learn and change. This motivation will be further strengthened by the use of the GlucoseMama monitoring system which will provide each patient with glucose tracking and individualized nutritional support.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Study Start: 2017-04-15
• Primary Completion: 2018-10-15
• Study Completion: 2019-05-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Diagnosis of Gestational Diabetes
• Planning on delivering at home institution

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Exclusion Criteria

• Unwilling to participate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group and Glucose Mama	GlucoseMama application with blood sugar monitoring and carb monitoring.	Enrolled subjects with have GlucoseMama application and group care.
Group and Glucose Mama	Group prenatal care for GDM.	Enrolled subjects with have GlucoseMama application and group care.
Traditional and glucoseMama	GlucoseMama application with blood sugar monitoring and carb monitoring.	Enrolled subjects will have traditional care and glucoseMama
Group and No Glucose Mama	Group prenatal care for GDM.	Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application.

Primary Outcome Measures

Name	Time	Method
Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes	2 years

Secondary Outcome Measures

Name	Time	Method
Increased number of individuals who are screened in the postpartum period for type 2 diabetes.	2 years
Reduction in the number of infants with neonatal hypoglycemia.	2 years
Reduction in the number of neonates born large for gestational age.	2 years

Trial Locations

Locations (1)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States