Back to resultsGroup and Mobile Care for Gestational Diabetes
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GlucoseMama application with blood sugar monitoring and carb monitoring.
Group prenatal care for GDM.
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Gestational Diabetes
- Planning on delivering at home institution
Exclusion Criteria:
- Unwilling to participate.
Sites / Locations
- University of Maryland, Baltimore
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
No Intervention
Arm Label
Group and Glucose Mama
Group and No Glucose Mama
Traditional and glucoseMama
Traditional and no GlucoseMama
Arm Description
Enrolled subjects with have GlucoseMama application and group care.
Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application.
Enrolled subjects will have traditional care and glucoseMama
enrolled subjects will not have access to group care or GlucoseMama.
Outcomes
Primary Outcome Measures
Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes
Secondary Outcome Measures
Reduction in the number of neonates born large for gestational age.
Increased number of individuals who are screened in the postpartum period for type 2 diabetes.
Reduction in the number of infants with neonatal hypoglycemia.
Full Information
NCT ID
NCT03026218
First Posted
January 11, 2017
Last Updated
March 7, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03026218
Brief Title
Group and Mobile Care for Gestational Diabetes
Official Title
Group and Mobile Care for Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group and Glucose Mama
Arm Type
Experimental
Arm Description
Enrolled subjects with have GlucoseMama application and group care.
Arm Title
Group and No Glucose Mama
Arm Type
Placebo Comparator
Arm Description
Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application.
Arm Title
Traditional and glucoseMama
Arm Type
Experimental
Arm Description
Enrolled subjects will have traditional care and glucoseMama
Arm Title
Traditional and no GlucoseMama
Arm Type
No Intervention
Arm Description
enrolled subjects will not have access to group care or GlucoseMama.
Intervention Type
Other
Intervention Name(s)
GlucoseMama application with blood sugar monitoring and carb monitoring.
Intervention 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(s)
Group prenatal care for GDM.
Intervention Description
group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.
Primary Outcome Measure Information:
Title
Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Reduction in the number of neonates born large for gestational age.
Time Frame
2 years
Title
Increased number of individuals who are screened in the postpartum period for type 2 diabetes.
Time Frame
2 years
Title
Reduction in the number of infants with neonatal hypoglycemia.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Gestational Diabetes
Planning on delivering at home institution
Exclusion Criteria:
Unwilling to participate.
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Group and Mobile Care for Gestational Diabetes
We'll reach out to this number within 24 hrs