Type 1 Diabetes Clinical Trial
Official title:
Social Media Use in Adolescent Diabetes Care
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Seattle Children's Hospital | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Seattle Children's Hospital |
United States,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
| Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
| Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
| Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
| Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
| Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
| Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
| Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
| Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
| Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
| Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
| Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
| Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
| Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
| Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|
||
| Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 |