Social Media Use in Adolescent Diabetes Care

December 28, 2023 updated by: Seattle Children's Hospital

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

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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.
Change over 6 months
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Faisal S Malik, MD, MSHS, Seattle Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00004205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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