The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- University of Louisville
- Locations
- 1
- Primary Endpoint
- glycemic control assessed by HbA1C level.
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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.
Investigators
Gwendolyn Pierce
Research Nurse
University of Louisville
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.
Outcomes
Primary Outcomes
glycemic control assessed by HbA1C level.
Time Frame: up to one year after randomization occurs
review of lab value
Secondary Outcomes
- number of hospitalizations related to T1D(up to one year after randomization occurs)
- number of episodes of severe hypoglycemia(up to one year after randomization occurs)
- number of episodes of Diabetic Ketoacidosis (DKA)(up to one year after randomization occurs)
- number of patient contacts to the diabetes educator(up to one year after randomization occurs)