mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM
Key facts
- Who runs it
- Tufts Medical Center
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 1 May 2023
- Ended
- 1 Feb 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Malama App
- Record updated
- 23 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Pregnant women receiving prenatal, delivery, and postpartum care at Tufts Medical Center
- 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
- >= 18 years of age
- Literate in English or Spanish (?additional languages pending app translation)
- Access to or ownership of a smartphone compatible with Malama
- Willing and able to sign the informed consent
Who cannot take part
- Diagnosis of pregestational diabetes
- Unable to tolerate oral glucose tolerance test (i.e. history of gastric bypass surgery)
- Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids)
- Does not own smartphone compatible with Malama application
- Severe life-limiting fetal anomaly
Where in United States
- Tufts Medical CenterBoston, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Malama ArmTreatment being tested
Participants enrolled in this arm will agree to using the Malama app to track glycemic management.
Treatment: Malama App
- ControlNo study treatment, for comparison
Participants enrolled in this arm agree to standard management (FS log on phone, notebook, etc)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Control Trial to Investigate the Effect of a Smartphone Application for Gestational Diabetes Management on Postpartum Glucose Intolerance
- Record updated
- 23 April 2025