Diabetes Mellitus, Type 1
Conditions
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.
Interventions
OTHERtext 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
OTHERtext 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
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycemic control assessed by HbA1C level. | up to one year after randomization occurs | review of lab value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed