Clinical trial NCT05597943: mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM
Official title: Randomized Control Trial to Investigate the Effect of a Smartphone Application for Gestational Diabetes Management on Postpartum Glucose Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
PreDiabetes
Pregnancy Related
Pregnancy, High Risk
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Malama app as intervention
timeFrame: 8-26 weeks
Secondary outcomes:
measure: Postpartum hemoglobin A1c level
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Sebastian Z Ramos, MD
role: STUDY_DIRECTOR
affiliation: Tufts Medical Center
name: Erika Werner, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: