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

University of Louisville (UOFL)

Status: Withdrawn

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: text message to parent only; Other: text message to parent and adolescent

Study type: Interventional

Funder types: Other

Identifiers

NCT02619487

01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 8 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

8-12 years old, parent receiving text

Experimental group

Description:

text message to parent only

Treatment:

Other: text message to parent only

13-18 years old, parent receiving text

Active Comparator group

Description:

text message to parent only

Treatment:

Other: text message to parent only

13-18 years, both receiving text

Active Comparator group

Description:

Text message to parent and adolescent

Treatment:

Other: text message to parent and adolescent

No text

No Intervention group

Description:

No text will be sent