Type 1 DiabetesNCT06085339
Social Media Use in Adolescent Diabetes Care
A study testing Social Media in people with Type 1 Diabetes, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Social Media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Faisal S Malik, MD, MSHS, 206-987-0121, faisal.malik@seattlechildrens.org
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Social Media
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social MediaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Enrollment
Percentage of participants who enroll in study after in-person or remote discussion about study participation.
Measured: 0 months
Feasibility: Retention Rate
Percentage of enrolled participants who complete the final 6-month surveys.
Measured: 6 months
Secondary outcomes (14)
Hemoglobin A1c (HbA1c)
HbA1c laboratory measurements collected during the intervention.
Measured: Change over 6 months
Time In Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL).
Measured: Change over 6 months
Time Above Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).
Measured: Change over 6 months
Time Below Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).
Measured: Change over 6 months
Diabetes Self-Management
Adherence will be assessed with the Diabetes Self-Management Questionnaire. Higher scores indicate higher adherence to diabetes self-management.
Measured: Change over 6 months
Diabetes Distress
Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress.
Measured: Change over 6 months
Diabetes Family Conflict
Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict.
Measured: Change over 6 months
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.
Measured: Change over 6 months
Depressive Symptoms
Depressive symptoms will be assessed with the Patient Health Questionnaire-8. Higher scores indicate higher depressive symptoms.
Measured: Change over 6 months
Mental Wellbeing
Mental wellbeing will be assessed with the Warwick-Edinburgh Mental Wellbeing Scale. Higher scores indicate higher mental wellbeing.
Measured: Change over 6 months
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.
Measured: Change over 6 months
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.
Measured: Change over 6 months
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.
Measured: Change over 6 months
Screen Time
Screen time use will be measured by the Screen Time summary from a participant's smartphone device.
Measured: Change over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start23 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faisal S Malik, MD, MSHS, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085339
- Sponsor's protocol ID
- STUDY00004205
- Status last verified
- Dec 2023
- First submitted
- 10 Oct 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Media Use in Adolescent Diabetes Care
- ClinicalTrials.gov ID
- NCT06085339
- Acronym / sponsor ID
- STUDY00004205
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Media Intervention | Experimental | Behavioral: Social MediaIn 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. |
| 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social MediaThe 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. | Behavioural | Social Media Intervention |
Primary outcome
Feasibility: Enrollment
Time frame: 0 months
Percentage of participants who enroll in study after in-person or remote discussion about study participation.
Feasibility: Retention Rate
Time frame: 6 months
Percentage of enrolled participants who complete the final 6-month surveys.
14 secondary outcomes
Hemoglobin A1c (HbA1c)
Time frame: Change over 6 months
Time In Range
Time frame: Change over 6 months
Time Above Range
Time frame: Change over 6 months
Time Below Range
Time frame: Change over 6 months
Diabetes Self-Management
Time frame: Change over 6 months
Diabetes Distress
Time frame: Change over 6 months
Diabetes Family Conflict
Time frame: Change over 6 months
Health Care Transition Readiness
Time frame: Change over 6 months
Depressive Symptoms
Time frame: Change over 6 months
Mental Wellbeing
Time frame: Change over 6 months
Problematic Internet Use
Time frame: Change over 6 months
Diabetes Strengths
Time frame: Change over 6 months
Diabetes Quality of Life
Time frame: Change over 6 months
Screen Time
Time frame: Change over 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faisal S Malik, MD, MSHS principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Media in people with Type 1 Diabetes, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faisal S Malik, MD, MSHS (206-987-0121, faisal.malik@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Enrollment (time frame: 0 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.