Group and Mobile Care for Gestational Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: GlucoseMama application with blood sugar monitoring and carb monitoring.; Other: Group prenatal care for GDM.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unwilling to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group and Glucose Mama; Enrolled subjects with have GlucoseMama application and group care.	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.; 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.
Placebo Comparator: Group and No Glucose Mama; Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application.	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.
Experimental: Traditional and glucoseMama; Enrolled subjects will have traditional care and glucoseMama	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.
No Intervention: Traditional and no GlucoseMama; enrolled subjects will not have access to group care or GlucoseMama.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: HP-00071275

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No