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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: text message to parent only
* Other: text message to parent and adolescent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8-12 years old, parent receiving text<br>text message to parent only | Other: text message to parent only<br>* 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<br>* Other names: e-health intervention;|
| Active Comparator: 13-18 years old, parent receiving text<br>text message to parent only | Other: text message to parent only<br>* 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<br>* Other names: e-health intervention;|
| Active Comparator: 13-18 years, both receiving text<br>Text message to parent and adolescent | Other: text message to parent and adolescent<br>* 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<br>|
| No Intervention: No text<br>No text will be sent | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control assessed by HbA1C level. | review of lab value | up to one year after randomization occurs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of episodes of Diabetic Ketoacidosis (DKA) | chart review of self reported episodes of Diabetic Ketoacidosis and chart review of hospitalizations related to DKA | up to one year after randomization occurs | 
| number of episodes of severe hypoglycemia | chart review of reported episodes of severe hypoglycemia and chart review of hospitalizations related to hypoglycemia | up to one year after randomization occurs | 
| number of patient contacts to the diabetes educator | chart review of educator documentation of communication with subject | up to one year after randomization occurs | 
| number of hospitalizations related to T1D | chart review of hospitalizations related to T1D | up to one year after randomization occurs |