Tufts Medical Center
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.
Gestational Diabetes
PreDiabetes
Pregnancy Related
Pregnancy, High Risk
Malama App
Not Applicable
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 Type : | Interventional |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
Official Title : | Randomized Control Trial to Investigate the Effect of a Smartphone Application for Gestational Diabetes Management on Postpartum Glucose Intolerance |
Actual Study Start Date : | May 1, 2023 |
Estimated Primary Completion Date : | May 1, 2024 |
Estimated Study Completion Date : | December 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Malama Arm Participants enrolled in this arm will agree to using the Malama app to track glycemic management. |
|
No Intervention: Control Participants enrolled in this arm agree to standard management (FS log on phone, notebook, etc) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Tufts Medical Center
Boston, Massachusetts, United States, 02111