Clinical trial NCT02619487: The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
Official title: The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: glycemic control assessed by HbA1C level.
timeFrame: up to one year after randomization occurs
Secondary outcomes:
measure: number of episodes of Diabetic Ketoacidosis (DKA)
timeFrame: up to one year after randomization occurs
measure: number of episodes of severe hypoglycemia
timeFrame: up to one year after randomization occurs
measure: number of patient contacts to the diabetes educator
timeFrame: up to one year after randomization occurs
measure: number of hospitalizations related to T1D
timeFrame: up to one year after randomization occurs
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Gwendolyn S Pierce, MSN
role: PRINCIPAL_INVESTIGATOR
References: