Group and Mobile Care for Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Group and Mobile Care for Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026218
• Other study ID #: HP-00071275
• Status: Completed
• Phase: N/A
• Start date: April 15, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: March 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 15, 2019
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Gestational Diabetes

• Planning on delivering at home institution

Exclusion Criteria:

• Unwilling to participate.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes		2 years
Secondary	Reduction in the number of neonates born large for gestational age.		2 years
Secondary	Increased number of individuals who are screened in the postpartum period for type 2 diabetes.		2 years
Secondary	Reduction in the number of infants with neonatal hypoglycemia.		2 years