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

NCT ID: NCT02619487

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2019-12-13

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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8-12 years old, parent receiving text

text message to parent only

Group Type EXPERIMENTAL

text message to parent only

Intervention Type 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 old, parent receiving text

text message to parent only

Group Type ACTIVE_COMPARATOR

text message to parent only

Intervention Type 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

Text message to parent and adolescent

Group Type ACTIVE_COMPARATOR

text message to parent and adolescent

Intervention Type 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

No text

No text will be sent

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Other Intervention Names

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e-health intervention

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Gwendolyn Pierce

Research Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gwendolyn S Pierce, MSN

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id