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Trial record 8 of 3260 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):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
Anticipated Study Start Date : August 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. glycemic control assessed by HbA1C level. [ Time Frame: up to one year after randomization occurs ]
    review of lab value


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. number of hospitalizations related to T1D [ Time Frame: up to one year after randomization occurs ]
    chart review of hospitalizations related to T1D


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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): NCT02619487


Contacts
Contact: Gwen S Pierce, MSN 502-588-3430 gspier01@louisville.edu

Locations
United States, Kentucky
University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Gwen S Pierce, MSN    502-588-3430    gspier01@louisville.edu   
Principal Investigator: Gwen S Pierce, MSN         
Principal Investigator: Kupper A Wintergerst, MD         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Gwendolyn S Pierce, MSN University of Louisville
More Information

Responsible Party: Gwendolyn Pierce, Research Nurse, University of Louisville
ClinicalTrials.gov Identifier: NCT02619487     History of Changes
Other Study ID Numbers: 01
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
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