The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes (Edu4U)

The purpose of this study is to determine whether a simple text message reminder sent to the parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in helping the individual(or parent) become more compliant with self-managing the Type 1 Diabetes (T1D). There will be 5 arms: text message sent to parents of children age 8-12 years old with T1D, text messages sent to parents of adolescents ,age 13-18 years old, with T1D,text messages sent to parents of adolescents with T1D as well as the adolescent with T1D,no text message sent to parents of children age 8-12 years, and no text message sent to adolescents or parents of adolescents age 13-18 years old.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: text message to parent only; Other: text message to parent and adolescent

Detailed Description

Managing Type 1 Diabetes requires daily checks of blood glucose and medication adjustments. Children and adolescents are known to have more difficulty with this than adults. Parents/legal guardians also face the task of helping with this self-management. A weekly text message regarding Type 1 Diabetes, sent to the parent or the parent and adolescent, may help to remind and motivate an individual to perform the daily tasks needed to manage their Type 1 Diabetes.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be willing to agree to participate(assent) in the study and have the permission of the parent to do so.
2. Have a diagnosis of Type 1 diabetes for ≥ one year.
3. Be aged 8 to 18 years old.
4. Be on insulin therapy for ≥ one year.
5. Have a parent/legal guardian with access to a working cell phone or have a parent/legal guardian with access to a working cell phone and have a working cell phone (if 13 years of age or older).
6. Utilize one of the following mobile carriers: T-Mobile, Sprint, Verizon, AT&T, or Virgin Mobile.
7. The parent/legal guardian must express intent to maintain a carrier plan for the duration of the study.
8. The parent/legal guardian must be able to read English OR the parent/legal guardian and the adolescent must be able to read English.

Exclusion Criteria:

1. Participants, who in the opinion of the investigator, have any contraindication to tight glycemic control.
2. Individuals who are unable to undertake blood glucose testing during the study period
3. Individuals who are deemed unable or unlikely to comply with the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8-12 years old, parent receiving text; text message to parent only	Other: text message to parent only; A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year; Other Names: e-health intervention
Active Comparator: 13-18 years old, parent receiving text; text message to parent only	Other: text message to parent only; A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year; Other Names: e-health intervention
Active Comparator: 13-18 years, both receiving text; Text message to parent and adolescent	Other: text message to parent and adolescent; A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year
No Intervention: No text; No text will be sent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glycemic control assessed by HbA1C level.	review of lab value	up to one year after randomization occurs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of episodes of Diabetic Ketoacidosis (DKA)	chart review of self reported episodes of Diabetic Ketoacidosis and chart review of hospitalizations related to DKA	up to one year after randomization occurs
number of episodes of severe hypoglycemia	chart review of reported episodes of severe hypoglycemia and chart review of hospitalizations related to hypoglycemia	up to one year after randomization occurs
number of patient contacts to the diabetes educator	chart review of educator documentation of communication with subject	up to one year after randomization occurs
number of hospitalizations related to T1D	chart review of hospitalizations related to T1D	up to one year after randomization occurs

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Gwendolyn S Pierce, MSN, University of Louisville

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): December 13, 2019
• Study Completion (Anticipated): December 13, 2019

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No