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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
text message to parent only
text message to parent and adolescent
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

8-12 years old, parent receiving text

13-18 years old, parent receiving text

13-18 years, both receiving text

No text

Arm Description

text message to parent only

text message to parent only

Text message to parent and adolescent

No text will be sent

Outcomes

Primary Outcome Measures

glycemic control assessed by HbA1C level.
review of lab value

Secondary Outcome Measures

number of episodes of Diabetic Ketoacidosis (DKA)
chart review of self reported episodes of Diabetic Ketoacidosis and chart review of hospitalizations related to DKA
number of episodes of severe hypoglycemia
chart review of reported episodes of severe hypoglycemia and chart review of hospitalizations related to hypoglycemia
number of patient contacts to the diabetes educator
chart review of educator documentation of communication with subject
number of hospitalizations related to T1D
chart review of hospitalizations related to T1D

Full Information

First Posted
June 8, 2015
Last Updated
December 13, 2018
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT02619487
Brief Title
The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
Acronym
Edu4U
Official Title
The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Due to limited staff resources, we were unable to start enrolling participants.
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
December 13, 2019 (Anticipated)
Study Completion Date
December 13, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8-12 years old, parent receiving text
Arm Type
Experimental
Arm Description
text message to parent only
Arm Title
13-18 years old, parent receiving text
Arm Type
Active Comparator
Arm Description
text message to parent only
Arm Title
13-18 years, both receiving text
Arm Type
Active Comparator
Arm Description
Text message to parent and adolescent
Arm Title
No text
Arm Type
No Intervention
Arm Description
No text will be sent
Intervention Type
Other
Intervention Name(s)
text message to parent only
Other Intervention Name(s)
e-health intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
text message to parent and adolescent
Intervention Description
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
Primary Outcome Measure Information:
Title
glycemic control assessed by HbA1C level.
Description
review of lab value
Time Frame
up to one year after randomization occurs
Secondary Outcome Measure Information:
Title
number of episodes of Diabetic Ketoacidosis (DKA)
Description
chart review of self reported episodes of Diabetic Ketoacidosis and chart review of hospitalizations related to DKA
Time Frame
up to one year after randomization occurs
Title
number of episodes of severe hypoglycemia
Description
chart review of reported episodes of severe hypoglycemia and chart review of hospitalizations related to hypoglycemia
Time Frame
up to one year after randomization occurs
Title
number of patient contacts to the diabetes educator
Description
chart review of educator documentation of communication with subject
Time Frame
up to one year after randomization occurs
Title
number of hospitalizations related to T1D
Description
chart review of hospitalizations related to T1D
Time Frame
up to one year after randomization occurs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be willing to agree to participate(assent) in the study and have the permission of the parent to do so. Have a diagnosis of Type 1 diabetes for ≥ one year. Be aged 8 to 18 years old. Be on insulin therapy for ≥ one year. 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). Utilize one of the following mobile carriers: T-Mobile, Sprint, Verizon, AT&T, or Virgin Mobile. The parent/legal guardian must express intent to maintain a carrier plan for the duration of the study. 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: Participants, who in the opinion of the investigator, have any contraindication to tight glycemic control. Individuals who are unable to undertake blood glucose testing during the study period Individuals who are deemed unable or unlikely to comply with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn S Pierce, MSN
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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