NCT06085339

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

October 10, 2023

Last Update Submit

December 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility: Enrollment

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

    0 months

  • Feasibility: Retention Rate

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

    6 months

Secondary Outcomes (14)

  • Hemoglobin A1c (HbA1c)

    Change over 6 months

  • Time In Range

    Change over 6 months

  • Time Above Range

    Change over 6 months

  • Time Below Range

    Change over 6 months

  • Diabetes Self-Management

    Change over 6 months

  • +9 more secondary outcomes

Study Arms (2)

Social Media Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Social MediaBEHAVIORAL

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.

Social Media Intervention

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Media Exposure

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SociologySocial SciencesBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Faisal S Malik, MD, MSHS

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Faisal S Malik, MD, MSHS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

October 23, 2023

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

January 3, 2024

Record last verified: 2023-12

Locations