- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06085339
Social Media Use in Adolescent Diabetes Care
The goal of this clinical trial is to evaluate the feasibility of a social media intervention to support diabetes management in adolescents with type 1 diabetes.
Adolescent participants will be randomized to receive diabetes education and peer support over Instagram or to usual outpatient diabetes care. Researchers will assess whether the social media intervention is feasible. In addition, the study team will also explore and compare changes in glucose levels and person-reported outcomes between the two groups.
Study Overview
Detailed Description
The majority of adolescents with type 1 diabetes do not meet recommended glycemic targets, placing them at risk for acute and chronic diabetes-related complications. Strategies that improve adolescent diabetes self-management are needed. Social media offers new opportunities to provide diabetes education and peer support through communication in a digital environment.
As part of a randomized controlled trial, adolescent participants will be randomized to receive diabetes education and peer support over Instagram in addition to usual care or to standard outpatient diabetes care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Faisal S Malik, MD, MSHS
- Phone Number: 206-987-0121
- Email: faisal.malik@seattlechildrens.org
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Hospital
-
Contact:
- Faisal S Malik, MD, MSHS
- Phone Number: 206-987-0121
- Email: faisal.malik@seattlechildrens.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with type 1 diabetes ≥12 months
- Most recent hemoglobin A1c (HbA1c) level is > 7.0%
- Currently use Dexcom continuous glucose monitoring (CGM) system
- Speak English fluently
- Cognitively able to participate in program on Instagram and complete surveys
- Have access to a personal Instagram account
- Found to be eligible on the Social Media Preference Screener
Exclusion Criteria:
- Patient is a ward of the state
- Patient is pregnant as diabetes standard of care is different during pregnancy (i.e., different glycemic targets and frequency of clinic visits)
- Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social Media Intervention
In addition to receiving usual care, participants enrolled in the social media arm will receive diabetes education and support over the course of 6 months by following the study team's Instagram page and engaging with the study team and other adolescent participants on Instagram.
|
The social media arm participants will receive a diabetes curriculum designed to address diabetes self-efficacy and independence with diabetes management over the course of 6 months.
Participants will have the option to engage with the study team and other participants through Instagram posts and direct messaging.
|
No Intervention: Usual Care
Usual care reflects the standard treatment currently provided to adolescents living with type 1 diabetes.
Every adolescent with diabetes is cared for by a team of diabetes specialists which includes a provider (MD, Physician Assistant and/or Nurse Practitioner), registered nurse, nutritionist and social worker.
Adolescents with type 1 diabetes are seen by their multidisciplinary team approximately every 3 months.
In addition, they have access to their multidisciplinary care team via telephone and/or MyChart communication as often as is necessary between clinic visits.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Enrollment
Time Frame: 0 months
|
Percentage of participants who enroll in study after in-person or remote discussion about study participation.
|
0 months
|
Feasibility: Retention Rate
Time Frame: 6 months
|
Percentage of enrolled participants who complete the final 6-month surveys.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time In Range
Time Frame: Change over 6 months
|
Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL).
|
Change over 6 months
|
Time Above Range
Time Frame: Change over 6 months
|
Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).
|
Change over 6 months
|
Time Below Range
Time Frame: Change over 6 months
|
Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).
|
Change over 6 months
|
Diabetes Self-Management
Time Frame: Change over 6 months
|
Adherence will be assessed with the Diabetes Self-Management Questionnaire.
Higher scores indicate higher adherence to diabetes self-management.
|
Change over 6 months
|
Diabetes Distress
Time Frame: Change over 6 months
|
Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version.
Higher scores indicate higher diabetes distress.
|
Change over 6 months
|
Diabetes Family Conflict
Time Frame: Change over 6 months
|
Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale.
Higher scores indicate higher diabetes family conflict.
|
Change over 6 months
|
Health Care Transition Readiness
Time Frame: Change over 6 months
|
Health care transition readiness will be assessed with the Readiness Assessment in Emerging Adults with Type 1 Diabetes Diagnosed in Youth.
Higher scores indicate higher health care transition readiness.
|
Change over 6 months
|
Depressive Symptoms
Time Frame: Change over 6 months
|
Depressive symptoms will be assessed with the Patient Health Questionnaire-8.
Higher scores indicate higher depressive symptoms.
|
Change over 6 months
|
Mental Wellbeing
Time Frame: Change over 6 months
|
Mental wellbeing will be assessed with the Warwick-Edinburgh Mental Wellbeing Scale.
Higher scores indicate higher mental wellbeing.
|
Change over 6 months
|
Problematic Internet Use
Time Frame: Change over 6 months
|
Adolescent problematic internet use will be assessed with the Problematic and Risky Internet Use Screening Scale.
Higher scores indicate higher concern for problematic internet use.
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Change over 6 months
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Diabetes Strengths
Time Frame: Change over 6 months
|
Adolescents' diabetes-specific "strengths" (i.e., positive behaviors and attitudes related to the challenges of living with type 1 diabetes) will be assessed with the Diabetes Strengths and Resilience measure.
Higher scores indicate increased diabetes-specific strengths.
|
Change over 6 months
|
Diabetes Quality of Life
Time Frame: Change over 6 months
|
Diabetes-specific quality of life will be assessed using the adolescent self-report version of the Type 1 Diabetes and Life.
Higher scores indicate higher diabetes-specific quality of life.
|
Change over 6 months
|
Screen Time
Time Frame: Change over 6 months
|
Screen time use will be measured by the Screen Time summary from a participant's smartphone device.
|
Change over 6 months
|
Hemoglobin A1c (HbA1c)
Time Frame: Change over 6 months
|
HbA1c laboratory measurements collected during the intervention.
|
Change over 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Faisal S Malik, MD, MSHS, Seattle Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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