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Trial record 8 of 3261 for:    Louisville

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

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ClinicalTrials.gov Identifier: NCT02619487
Recruitment Status : Not yet recruiting
First Posted : December 2, 2015
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):

June 8, 2015
December 2, 2015
November 9, 2017
August 2018
November 2018   (Final data collection date for primary outcome measure)
glycemic control assessed by HbA1C level. [ Time Frame: up to one year after randomization occurs ]
review of lab value
Same as current
Complete list of historical versions of study NCT02619487 on ClinicalTrials.gov Archive Site
  • number of episodes of Diabetic Ketoacidosis (DKA) [ Time Frame: up to one year after randomization occurs ]
    chart review of self reported episodes of Diabetic Ketoacidosis and chart review of hospitalizations related to DKA
  • number of episodes of severe hypoglycemia [ Time Frame: up to one year after randomization occurs ]
    chart review of reported episodes of severe hypoglycemia and chart review of hospitalizations related to hypoglycemia
  • number of patient contacts to the diabetes educator [ Time Frame: up to one year after randomization occurs ]
    chart review of educator documentation of communication with subject
  • number of hospitalizations related to T1D [ Time Frame: up to one year after randomization occurs ]
    chart review of hospitalizations related to T1D
Same as current
Not Provided
Not Provided
 
The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Diabetes Mellitus, Type 1
  • 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 Name: e-health intervention
  • 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
  • Experimental: 8-12 years old, parent receiving text
    text message to parent only
    Intervention: Other: text message to parent only
  • Active Comparator: 13-18 years old, parent receiving text
    text message to parent only
    Intervention: Other: text message to parent only
  • Active Comparator: 13-18 years, both receiving text
    Text message to parent and adolescent
    Intervention: Other: text message to parent and adolescent
  • No Intervention: No text
    No text will be sent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
178
May 2020
November 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
8 Years to 18 Years   (Child, Adult)
No
Contact: Gwen S Pierce, MSN 502-588-3430 gspier01@louisville.edu
United States
 
 
NCT02619487
01
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Gwendolyn Pierce, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Gwendolyn S Pierce, MSN University of Louisville
University of Louisville
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP