Texting Intervention for Gestational Diabetes

Recruiting at 1 trial location

Overseen By Katherine Mathews, MD, MPH, MBA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: St. Louis University

Disqualifiers: Hospitalization, Fetal malformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 9 months

185 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Diabetes is a common complication of pregnancy that increases risks for both the mother and baby. Poorly controlled diabetes has been associated with very large babies, congenital heart defects, stillbirth, birth trauma, and maternal infections among other complications. Patients with diabetes in pregnancy require more frequent prenatal visits and fetal evaluation, and must shoulder the burden of mastering management of a complicated care regimen. With the ever-expanding world of technology, more healthcare practices are using cell phones, texting, and social media to interact with patients. Use of this technology has been successful in management of chronic diseases and as reminder systems. The investigators propose a randomized clinical trial to investigate patient adherence to recommended care regimen after intervention of a text message reminder and education system.

Who Is on the Research Team?

Dorothea Mostello, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 or older with either gestational diabetes or pre-existing diabetes and a confirmed viable single pregnancy. They must have access to a cell phone with texting capabilities. Women hospitalized for pregnancy complications or without a cell phone, as well as those carrying babies with malformations, cannot participate.

Inclusion Criteria

The patient has access to a cellular phone with a text messaging plan

I have diabetes and am currently pregnant.

I am a pregnant woman aged 18 or older.

Exclusion Criteria

The patient becomes hospitalized for a pregnancy complication for the remainder of pregnancy

The patient does not have a cellular phone

My unborn baby has been diagnosed with a genetic or structural abnormality.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive diabetes education and are started on an individualized diabetic diet regimen. Text message reminders are sent for appointments and medication adherence.

Up to 9 months

Regular prenatal visits with text reminders

Postpartum Follow-up

Participants receive text message reminders for postpartum glucose tolerance tests at 2, 6, and 10 weeks postpartum.

10 weeks

Postpartum visits with text reminders

Survey Completion

Participants complete surveys to evaluate barriers to healthcare and perspectives on the study.

Ongoing until postpartum visit

What Are the Treatments Tested in This Trial?

Interventions

• Texting

Trial Overview The study is testing whether text message reminders and educational content can help pregnant women with diabetes better adhere to their care regimen. Participants will be randomly assigned to receive these text interventions and their adherence to the recommended care will be monitored.

How Is the Trial Designed?

Group I: Texting Active Control 1 Intervention

Patients in the "Texting" group will receive reminders based on their individual disease treatment. A text message shall be sent one day (12 to 36 hours) before appointments to remind about the appointment and with instructions to bring glucose and food records to the appointment. If medication changes are made at the appointment, the patient will receive a text message reminder the day after her appointment to reinforce the regimen. Postpartum patients who had GDM will receive a text message reminder to complete their glucose tolerance test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10 weeks postpartum if the testing is not completed.

Group II: No texting Active Control 1 Intervention

Patients in the contact control group will be enrolled in the text4baby program with assistance from a healthcare provider. As the study will conclude upon the patient's postpartum visit, she will be offered the option of discontinuing messages, which otherwise would continue through the infant's first year of life.

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+