Group and Mobile Care for Gestational Diabetes

NCT ID: NCT03026218

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2019-05-15

Brief Summary

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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

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group and Glucose Mama

Enrolled subjects with have GlucoseMama application and group care.

Group Type EXPERIMENTAL

GlucoseMama application with blood sugar monitoring and carb monitoring.

Intervention Type OTHER

We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals.

Group prenatal care for GDM.

Intervention Type OTHER

group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.

Group and No Glucose Mama

Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application.

Group Type PLACEBO_COMPARATOR

Group prenatal care for GDM.

Intervention Type OTHER

group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.

Traditional and glucoseMama

Enrolled subjects will have traditional care and glucoseMama

Group Type EXPERIMENTAL

GlucoseMama application with blood sugar monitoring and carb monitoring.

Intervention Type OTHER

We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals.

Traditional and no GlucoseMama

enrolled subjects will not have access to group care or GlucoseMama.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GlucoseMama application with blood sugar monitoring and carb monitoring.

We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals.

Intervention Type OTHER

Group prenatal care for GDM.

group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unwilling to participate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Sarah Crimmins

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00071275

Identifier Type: -

Identifier Source: org_study_id

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