Social Media Use in Adolescent Diabetes Care

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06085339
Collaborator
(none)
60
1
2
11
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social Media
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Social Media Use in Adolescent Diabetes Care
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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.

Behavioral: Social Media
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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility: Enrollment [0 months]

    Percentage of participants who enroll in study after in-person or remote discussion about study participation.

  2. Feasibility: Retention Rate [6 months]

    Percentage of enrolled participants who complete the final 6-month surveys.

Secondary Outcome Measures

  1. HbA1c [Change over 6 months]

    HbA1c laboratory measurements collected during the intervention.

  2. Time In Range [Change over 6 months]

    Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL).

  3. Time Above Range [Change over 6 months]

    Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).

  4. Time Below Range [Change over 6 months]

    Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).

  5. Diabetes Self-Management [Change over 6 months]

    Adherence will be assessed with the Diabetes Self-Management Questionnaire. Higher scores indicate higher adherence to diabetes self-management.

  6. Diabetes Distress [Change over 6 months]

    Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress.

  7. Diabetes Family Conflict [Change over 6 months]

    Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict.

  8. Health Care Transition Readiness [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.

  9. Depressive Symptoms [Change over 6 months]

    Depressive symptoms will be assessed with the Patient Health Questionnaire-8. Higher scores indicate higher depressive symptoms.

  10. Mental Wellbeing [Change over 6 months]

    Mental wellbeing will be assessed with the Warwick-Edinburgh Mental Wellbeing Scale. Higher scores indicate higher mental wellbeing.

  11. Problematic Internet Use [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.

  12. Diabetes Strengths [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.

  13. Diabetes Quality of Life [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.

  14. Screen Time [Change over 6 months]

    Screen time use will be measured by the Screen Time summary from a participant's smartphone device.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosed with type 1 diabetes ≥12 months

  • Most recent HbA1c level is > 7.0%

  • Currently use Dexcom CGM device

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seattle Children's Hospital Seattle Washington United States 98105

Sponsors and Collaborators

  • Seattle Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT06085339
Other Study ID Numbers:
  • STUDY00004205
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2023