Texting for Diabetes

NCT03025984 | Active Not Recruiting

• 1 other identifier: 22596
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

diabetes pregnancy text message

Outcome Measures

Primary Outcomes (1)

• compliant diabetes care

  Compliant with appointments, maintaining diabetes records, and medications, including glycemic control and pregnancy complications.

  up to 12 months

Study Arms (2)

Texting

ACTIVE COMPARATOR

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.

Behavioral: Texting

No texting

NO 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.

Interventions

Texting BEHAVIORAL

patient adherence to her recommended care regimen after intervention of a text message reminder and education system

Texting

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient is a pregnant person 18 years of age or older
• The patient has been diagnosed with gestational diabetes or is a patient with known diabetes and a confirmed viable pregnancy
• The pregnancy has a singleton pregnancy
• The patient has access to a cellular phone with a text messaging plan

You may not qualify if:

• The patient does not have a cellular phone
• The patient becomes hospitalized for a pregnancy complication for the remainder of pregnancy
• The fetus has a chromosomal or non-chromosomal malformation

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dorothea Mostello, MD

  St. Louis University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 20, 2017
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)