mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597943
• Other study ID #: STUDY00003186
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Tufts Medical Center
• Contact: Alysa St. Charles, MA
• Phone: 617-636-9897
• Email: astcharles1[@]tuftsmedicalcenter.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• PreDiabetes
• Pregnancy Related
• Pregnancy, High Risk

Intervention

Behavioral:
• Malama App
The Malama smartphone application is a gestational diabetes management app that syncs directly with commercially-available glucometers via Bluetooth, enabling both automatic blood glucose logging and providing interactive diet management/diet education tools. We aim to perform a pilot study assessing the impact of the Malama smartphone application on perinatal and postpartum outcomes in patients with GDM.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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