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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06085339
Other study ID # STUDY00004205
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 23, 2023
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Seattle Children's Hospital
Contact Faisal S Malik, MD, MSHS
Phone 206-987-0121
Email faisal.malik@seattlechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Seattle Children's Hospital Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility: Enrollment Percentage of participants who enroll in study after in-person or remote discussion about study participation. 0 months
Primary Feasibility: Retention Rate Percentage of enrolled participants who complete the final 6-month surveys. 6 months
Secondary Hemoglobin A1c (HbA1c) HbA1c laboratory measurements collected during the intervention. Change over 6 months
Secondary Time In Range Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL). Change over 6 months
Secondary Time Above Range Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL). Change over 6 months
Secondary Time Below Range Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL). Change over 6 months
Secondary Diabetes Self-Management Adherence will be assessed with the Diabetes Self-Management Questionnaire. Higher scores indicate higher adherence to diabetes self-management. Change over 6 months
Secondary Diabetes Distress Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress. Change over 6 months
Secondary Diabetes Family Conflict Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict. Change over 6 months
Secondary Health Care Transition Readiness 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
Secondary Depressive Symptoms Depressive symptoms will be assessed with the Patient Health Questionnaire-8. Higher scores indicate higher depressive symptoms. Change over 6 months
Secondary Mental Wellbeing Mental wellbeing will be assessed with the Warwick-Edinburgh Mental Wellbeing Scale. Higher scores indicate higher mental wellbeing. Change over 6 months
Secondary Problematic Internet Use 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
Secondary Diabetes Strengths 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
Secondary Diabetes Quality of Life 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
Secondary Screen Time Screen time use will be measured by the Screen Time summary from a participant's smartphone device. Change over 6 months
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