NCT03026218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

January 11, 2017

Last Update Submit

March 7, 2022

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes

    2 years

Secondary Outcomes (3)

  • 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

Study Arms (4)

Group and Glucose Mama

EXPERIMENTAL

Enrolled subjects with have GlucoseMama application and group care.

Other: GlucoseMama application with blood sugar monitoring and carb monitoring.Other: Group prenatal care for GDM.

Group and No Glucose Mama

PLACEBO COMPARATOR

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

Other: Group prenatal care for GDM.

Traditional and glucoseMama

EXPERIMENTAL

Enrolled subjects will have traditional care and glucoseMama

Other: GlucoseMama application with blood sugar monitoring and carb monitoring.

Traditional and no GlucoseMama

NO INTERVENTION

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

Interventions

GlucoseMama application with blood sugar monitoring and carb monitoring.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 and Glucose MamaTraditional and glucoseMama
Group prenatal care for GDM.OTHER

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

Group and Glucose MamaGroup and No Glucose Mama

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 20, 2017

Study Start

April 15, 2017

Primary Completion

October 15, 2018

Study Completion

May 15, 2019

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

US(1)