Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy

Gestational Diabetes Clinical Trial

— Sugar Text  

Official title:

Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973374
• Other study ID #: 817181
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: February 19, 2015
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can be minimized with tight glucose control. A number of studies in non-pregnant populations have highlighted the feasibility, acceptability and efficacy of text messaging interventions for improving diabetic compliance and control. This study will investigate whether a text messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and whether this intervention can improve compliance with diabetes care, glucose control and pregnancy outcomes. The study will also assess satisfaction with the intervention itself.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women aged 18-50 years

• Planned delivery at Hospital of the University of Pennsylvania

Exclusion Criteria:

• Gestational age greater than 34 weeks at initial visit in the Penn Perinatal Diabetes Program

• Women who are unable to read English as all text messages will be in English

• Women who do not have a cellular phone capable of receiving text messages as this is the study intervention

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes in Pregnancy
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy in Diabetics
• Texting Interventions

Intervention

Behavioral:
• Text Message Intervention

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	Patient satisfaction with the texting intervention as measured by a post-study survey	date of enrollment up to 12 weeks post partum	No
Primary	Compliance with Obstetric and Diabetes Care	Proportion of prenatal visits attended, proportion of assigned blood glucose logs sent to clinic for review, proportion of assigned blood glucose values checked, compliance with attendance at postpartum visit.	OB screening visit through 12 weeks postpartum	No
Secondary	Efficacy measures	Measuring the proportion of blood glucose values within the target range each week; mean fasting and postprandial blood glucose values measured weekly; change in hemoglobin A1C (for pregestational diabetics) from initiation of care to the third trimester	Diabetes diagnosis through 12 weeks postpartum	No
Secondary	Healthcare Utilization Measures	Measuring the number of visits to the perinatal evaluation center related to diabetes care and the total number of antepartum hospitalizations.	Screening OB visit through 12 weeks postpartum	No
Secondary	Maternal Outcomes	Measuring the mode of delivery (spontaneous vaginal, operative vaginal, cesarean section), complications of delivery (shoulder dystocia, postpartum hemorrhage, third and fourth degree lacerations), and length of hospital stay.	Delivery date through 12 weeks postpartum	No
Secondary	Neonatal Outcomes	Measuring fetal demise; neonatal death; birthweight; large for gestational age; small for gestational age; APGAR scores; umbilical cord blood gas; NICU admission; respiratory distress; hypoglycemia; hyperbilirubinemia; length of hospital stay	Neonate delivery through 12 weeks postpartum	No