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MyDiaText Text Messaging Intervention for Diabetes

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ClinicalTrials.gov Identifier: NCT02927639
Recruitment Status : Not yet recruiting
First Posted : October 7, 2016
Last Update Posted : May 25, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
To develop a text messaging intervention using MyDiaText and to determine whether such an intervention will decrease HbA1c in children 12 to 18 years old. The intervention will consist of daily text messages sent to the subject's personal mobile device. Previously developed text messages based on the American Diabetes Association (ADA) behavior goals will be used for this intervention. These will be adapted with input from the focus groups that will be carried out with adolescents with Type 1 diabetes mellitus (T1DM). The details of the intervention, such as frequency and timing of text messages, will be determined from input obtained from the focus groups.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: MyDiaText Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: MyDiaText: Texting the Way to Better Diabetes Control
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Intervention
This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Previously developed text messages based on the ADA behavior goals will be used for this intervention.
Other: MyDiaText
The intervention will consist of daily text messages sent to the subject's personal mobile device.

Control First, then Intervention
This group will not receive the intervention in the first 3 months, just the usual standard of care. After the first 3 months, this group will also receive the intervention but for only 3 months.
Other: MyDiaText
The intervention will consist of daily text messages sent to the subject's personal mobile device.




Primary Outcome Measures :
  1. Change in HbA1c from baseline to 3 months [ Time Frame: 3 months ]
    Hemoglobin A1c will be drawn at baseline and repeated at the end of the study period. Change in HbA1c will be compared between the two groups.


Secondary Outcome Measures :
  1. Change in Self-Care Inventory (SCI) score from baseline to 3 months [ Time Frame: 3 months ]
    Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. The SCI is a 14-question, self-report measure of perceived adherence to diabetes self-care recommendations using a 5-point Likert 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.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of T1DM 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

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): NCT02927639


Contacts
Contact: Tara Kaushal, MD (267) 357-3678 Kaushalt@email.chop.edu
Contact: Terri Lipman, PhD 215-590-3174 lipman@nursing.upenn.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tara Kaushal, MD    267-357-3678    Kaushalt@email.chop.edu   
Contact: Terri Lipman, PhD    (267) 239-7052    Lipman@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Terri Lipman, PhD CHOP

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02927639     History of Changes
Other Study ID Numbers: 16-013222
T32DK063688-13S1 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases