NCT05597943

mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

Randomized Control Trial to Investigate the Effect of a Smartphone Application for Gestational Diabetes Management on Postpartum Glucose Intolerance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2022-10-28
• Last updated: 2025-04-23

Locations

1 site across 1 country: United States