mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

NCT ID: NCT05597943

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-02-01

Brief Summary

Without intervention, approximately 70% of women diagnosed with GDM will develop type 2 diabetes mellitus in their lifetime. Abnormal results of a 2 hour oral glucose tolerance test (OGTT) performed as early as 2 days postpartum are predictive of impaired glucose tolerance 1 year postpartum. The investigators hypothesize that use of the Malama smartphone application to optimize antenatal glycemic control will result in lower incidence of postpartum glucose intolerance, which may decrease long term risk of progression to diabetes mellitus.

Detailed Description

The effect of smartphone applications for gestational diabetes management on risk of postpartum glucose intolerance, antenatal glycemic control, and other perinatal outcomes is unknown.

This study is a randomized control trial in which patients diagnosed with gestational diabetes will be randomized to use of the Malama app vs. standard care as described above.

The primary aim of the study is to investigate if the incidence of postpartum glucose intolerance is lower in patients using the Malama app for gestational diabetes management compared to patients receiving standard care.

Secondary outcomes that will be investigated include several markers of maternal and neonatal perinatal morbidity. Maternal outcomes that will be investigated include postpartum hemoglobin A1c level, interval pregnancy weight gain, incidence of hypertensive disorders of pregnancy, cesarean delivery, operative delivery, postpartum hemorrhage, and advanced perineal lacerations. Neonatal secondary outcomes include gestational age at delivery, birthweight and incidence of large for gestational age infants, shoulder dystocia, NICU admission, length of NICU stay, neonatal blood glucose nadir, and need for neonatal IV glucose support.

Conditions

Gestational Diabetes; PreDiabetes; Pregnancy Related; Pregnancy, High Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Malama Arm

Participants enrolled in this arm will agree to using the Malama app to track glycemic management.

Group Type: EXPERIMENTAL

Malama App

Intervention Type: BEHAVIORAL

The Malama smartphone application is a gestational diabetes management app that syncs directly with commercially-available glucometers via Bluetooth, enabling both automatic blood glucose logging and providing interactive diet management/diet education tools. We aim to perform a pilot study assessing the impact of the Malama smartphone application on perinatal and postpartum outcomes in patients with GDM.

Control

Participants enrolled in this arm agree to standard management (FS log on phone, notebook, etc)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Malama App

The Malama smartphone application is a gestational diabetes management app that syncs directly with commercially-available glucometers via Bluetooth, enabling both automatic blood glucose logging and providing interactive diet management/diet education tools. We aim to perform a pilot study assessing the impact of the Malama smartphone application on perinatal and postpartum outcomes in patients with GDM.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Pregnant women receiving prenatal, delivery, and postpartum care at Tufts Medical Center

2. Gestational diabetes diagnosed between 14 0/7 and 31 6/7 weeks gestation on basis of 1-hour glucose challenge test result of >=200 mg/dL or Carpenter-Coustan criteria

3. >= 18 years of age

4. Literate in English or Spanish (?additional languages pending app translation)

5. Access to or ownership of a smartphone compatible with Malama

6. Willing and able to sign the informed consent

Exclusion Criteria

1. Unable to tolerate oral glucose tolerance test (i.e. history of gastric bypass surgery)

2. Diagnosis of pregestational diabetes

3. Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids)

4. Does not own smartphone compatible with Malama application

5. Severe life-limiting fetal anomaly

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastian Z Ramos, MD

Role: STUDY_DIRECTOR

Tufts Medical Center

Erika Werner, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

STUDY00003186

Identifier Type: -

Identifier Source: org_study_id