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

Diabetes Mellitus, Type 1 Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02619487
• Other study ID #: 01
• Status: Withdrawn
• Phase: N/A
• Start date: March 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: December 2018
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• text 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
• text 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

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control assessed by HbA1C level.	review of lab value	up to one year after randomization occurs
Secondary	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
Secondary	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
Secondary	number of patient contacts to the diabetes educator	chart review of educator documentation of communication with subject	up to one year after randomization occurs
Secondary	number of hospitalizations related to T1D	chart review of hospitalizations related to T1D	up to one year after randomization occurs