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

NCT02619487 | Withdrawn

• 1 other identifier: 01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• glycemic control assessed by HbA1C level.

  review of lab value

  up to one year after randomization occurs

Secondary Outcomes (4)

• number of episodes of Diabetic Ketoacidosis (DKA)

  up to one year after randomization occurs

• number of episodes of severe hypoglycemia

  up to one year after randomization occurs

• number of patient contacts to the diabetes educator

  up to one year after randomization occurs

• number of hospitalizations related to T1D

  up to one year after randomization occurs

Study Arms (4)

8-12 years old, parent receiving text

EXPERIMENTAL

text message to parent only

Other: text message to parent only

13-18 years old, parent receiving text

ACTIVE COMPARATOR

text message to parent only

Other: text message to parent only

13-18 years, both receiving text

ACTIVE COMPARATOR

Text message to parent and adolescent

Other: text message to parent and adolescent

No text

NO INTERVENTION

No text will be sent

Interventions

text message to parent only OTHER

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

Also known as: e-health intervention

13-18 years old, parent receiving text; 8-12 years old, parent receiving text

text message to parent and adolescent OTHER

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

13-18 years, both receiving text

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gwendolyn S Pierce, MSN

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: December 2, 2015
• Study Start: March 1, 2019
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)