← Back to all trials
Not Yet Recruiting
NCT05597943
mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM
Conditions: Gestational Diabetes, PreDiabetes, Pregnancy Related, Pregnancy, High Risk
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: Tufts Medical Center
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Pregnant women receiving prenatal, delivery, and postpartum care at Tufts Medical CenterGestational 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>= 18 years of ageLiterate in English or Spanish (?additional languages pending app translation)Access to or ownership of a smartphone compatible with MalamaWilling and able to sign the informed consentExclusion Criteria:Unable to tolerate oral glucose tolerance test (i.e.
history of gastric bypass surgery)Diagnosis of pregestational diabetesPrescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids)Does not own smartphone compatible with Malama applicationSevere life-limiting fetal anomaly
Source: ClinicalTrials.gov (NCT05597943). StuddyBuddy aggregates publicly available trial information.