Type 1 Diabetes
Conditions
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.
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.
Interventions
BEHAVIORALSocial 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.
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Enrollment | 0 months | Percentage of participants who enroll in study after in-person or remote discussion about study participation. |
| Feasibility: Retention Rate | 6 months | Percentage of enrolled participants who complete the final 6-month surveys. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Above Range | Change over 6 months | Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (\>180 mg/dL). |
| Time Below Range | Change over 6 months | Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (\<70 mg/dL). |
| 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. |
| 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. |
| 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. |
| 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. |
| Hemoglobin A1c (HbA1c) | Change over 6 months | HbA1c laboratory measurements collected during the intervention. |
| Mental Wellbeing | Change over 6 months | Mental wellbeing will be assessed with the Warwick-Edinburgh Mental Wellbeing Scale. Higher scores indicate higher mental wellbeing. |
| 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. |
| 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. |
| 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. |
| Screen Time | Change over 6 months | Screen time use will be measured by the Screen Time summary from a participant's smartphone device. |
| Depressive Symptoms | Change over 6 months | Depressive symptoms will be assessed with the Patient Health Questionnaire-8. Higher scores indicate higher depressive symptoms. |
| 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). |
Countries
United States
Contacts
Primary ContactFaisal S Malik, MD, MSHS
Outcome results
None listed