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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05597943
Study type Interventional
Source Tufts Medical Center
Contact Alysa St. Charles, MA
Phone 617-636-9897
Email astcharles1@tuftsmedicalcenter.org
Status Recruiting
Phase N/A
Start date May 1, 2023
Completion date December 1, 2024

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