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Texting for Diabetes

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ClinicalTrials.gov Identifier: NCT03025984
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Dorothea Mostello, MD, St. Louis University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Texting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adherence to a Diabetes Care Regimen Following Text Message Intervention in Pregnant Women With Diabetes
Study Start Date : December 2016
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
Active Comparator: Texting
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
patient adherence to her recommended care regimen after intervention of a text message reminder and education system

No Intervention: No texting
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.



Primary Outcome Measures :
  1. compliant diabetes care [ Time Frame: up to 12 months ]
    Compliant with appointments, maintaining diabetes records, and medications, including glycemic control and pregnancy complications.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is a pregnant female 18 years of age or older
  2. The patient has been diagnosed with gestational diabetes or is a patient with known diabetes and a confirmed viable pregnancy
  3. The pregnancy has a singleton pregnancy
  4. The patient has access to a cellular phone with a text messaging plan

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025984


Contacts
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Contact: Shohreh Jamalabadi-Majidi, DMD, MPH 314-977-2200 shohreh.jamalabadimajidi@health.slu.edu
Contact: Katherine Mathews, MD, MPH, MBA 314-977-2083 katherine.mathews@health.slu.edu

Locations
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United States, Missouri
St. Mary's Health Center Recruiting
Saint Louis, Missouri, United States, 63117
Sponsors and Collaborators
St. Louis University
Investigators
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Study Chair: Dorothea Mostello, MD St. Louis University
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Responsible Party: Dorothea Mostello, MD, Principal Investigator, St. Louis University
ClinicalTrials.gov Identifier: NCT03025984    
Other Study ID Numbers: 22596
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases