MyDiaText Text Messaging Intervention for Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

MyDiaText: Texting the Way to Better Diabetes Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927639
• Other study ID #: 16-013222
• Secondary ID: T32DK063688-13S1
• Status: Completed
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: May 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test a text messaging intervention using MyDiaText and financial incentives to determine whether such an intervention will improve self-reported self-care behaviors in children 12 to 18 years old. The intervention will consist of daily text messages sent to the subject's personal mobile device. Subjects will be incentivized to respond to text messages via a lottery financial incentive. Previously developed text messages based on the American Diabetes Association (ADA) behavior goals will be used for this intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of type 1 diabetes for more than 1 year

• HbA1c greater than or equal to 8% but less than 14%.

• Have been seen in diabetes clinic in the last 6 months

• Owns a personal mobile device with unlimited text messaging plan

Exclusion Criteria:

• Non-English speaking

• Significant cognitive disability or major organ illness

• Hemolytic anemia

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• MyDiaText
The intervention will consist of daily text messages sent to the subject's personal mobile device.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months	Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score.	6 months
Secondary	Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months	Hemoglobin A1c is a measure of glycemic control scale that reflects how well they followed recommendations for self-care during the past month (1="never do it" to 5 ="always do this as recommended, without fail"). Total scores range from 1-70 and previous data shows that youth with better self-care levels (higher scores) have significantly better glycemic control.	6 months