Edu4U: The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
Study Details
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 | Phase |
|---|---|---|
|
N/A |
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
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 Names:
|
| 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:
|
| 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
- glycemic control assessed by HbA1C level. [up to one year after randomization occurs]
review of lab value
Secondary Outcome Measures
- number of episodes of Diabetic Ketoacidosis (DKA) [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 [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 [up to one year after randomization occurs]
chart review of educator documentation of communication with subject
- number of hospitalizations related to T1D [up to one year after randomization occurs]
chart review of hospitalizations related to T1D
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be willing to agree to participate(assent) in the study and have the permission of the parent to do so.
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Have a diagnosis of Type 1 diabetes for ≥ one year.
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Be aged 8 to 18 years old.
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Be on insulin therapy for ≥ one year.
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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).
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Utilize one of the following mobile carriers: T-Mobile, Sprint, Verizon, AT&T, or Virgin Mobile.
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The parent/legal guardian must express intent to maintain a carrier plan for the duration of the study.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Louisville | Louisville | Kentucky | United States | 40202 |
Sponsors and Collaborators
- University of Louisville
Investigators
- Principal Investigator: Gwendolyn S Pierce, MSN, University of Louisville
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01