Pregnancy Related Clinical Trial
Official title:
Randomized Control Trial to Investigate the Effect of a Smartphone Application for Gestational Diabetes Management on Postpartum Glucose Intolerance
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Malama app as intervention | 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. | 8-26 weeks | |
Secondary | Postpartum hemoglobin A1c level | We will be measuring the postpartum A1c level to capture whether the mobile health app influences blood glucose levels based on glycemic control log method (app for intervention arm, pen-and-paper log for control). | 6 months |
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