Group and Mobile Care for Gestational Diabetes

Group and Mobile Care for Gestational Diabetes

Sponsors

Lead Sponsor: University of Maryland, Baltimore

Source 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.

Overall Status Completed
Start Date April 15, 2017
Completion Date May 15, 2019
Primary Completion Date October 15, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes 2 years
Secondary Outcome
Measure Time Frame
Reduction in the number of neonates born large for gestational age. 2 years
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
Enrollment 22
Condition
Intervention

Intervention Type: Other

Intervention Name: GlucoseMama application with blood sugar monitoring and carb monitoring.

Description: 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

Intervention Name: Group prenatal care for GDM.

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

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosis of Gestational Diabetes

- Planning on delivering at home institution

Exclusion Criteria:

- Unwilling to participate.

Gender: Female

Minimum Age: 18 Years

Maximum Age: 51 Years

Healthy Volunteers: No

Location
Facility: University of Maryland, Baltimore
Location Countries

United States

Verification Date

December 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Maryland, College Park

Investigator Full Name: Sarah Crimmins

Investigator Title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Group and Glucose Mama

Type: Experimental

Description: Enrolled subjects with have GlucoseMama application and group care.

Label: Group and No Glucose Mama

Type: Placebo Comparator

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

Label: Traditional and glucoseMama

Type: Experimental

Description: Enrolled subjects will have traditional care and glucoseMama

Label: Traditional and no GlucoseMama

Type: No Intervention

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov