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Diabetes Journey Program for Type 1 Diabetes

N/A
Waitlist Available
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescents with T1D ages 13-17
T1D diagnosis >1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month follow-up
Awards & highlights

Study Summary

This trial will test a web-based intervention to help teens with Type 1 diabetes better manage their disease by addressing common barriers to adherence.

Who is the study for?
This trial is for English-speaking adolescents aged 13-17 with Type 1 Diabetes (T1D) diagnosed over a year ago. They must have experienced barriers to managing their diabetes, as indicated by specific scores on the Barriers to Diabetes Adherence questionnaire. Those with significant developmental disorders or certain comorbid medical conditions are not eligible.Check my eligibility
What is being tested?
The study is testing 'Diabetes Journey,' a web-based program designed to help teenagers with T1D overcome challenges in sticking to their treatment plans. It will be compared against the Enhanced Standard of Care to assess its usefulness and how well it's received by participants.See study design
What are the potential side effects?
Since this intervention involves a web-based program rather than medication, traditional side effects are not expected. However, there may be indirect effects related to changes in behavior or stress levels due to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 17 years old with Type 1 Diabetes.
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I was diagnosed with Type 1 Diabetes over a year ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Barriers to Diabetes Adherence questionnaire - Youth report Time Pressure/Planning Subscale
Barriers to Diabetes Adherence questionnaire-Youth report Stress/Burnout Subscale
Secondary outcome measures
Adherence
Adherence for Continuous Glucose Monitors
Adherence for Insulin Pump Users
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diabetes JourneyExperimental Treatment1 Intervention
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Group II: Enhanced Standard of CareActive Control1 Intervention
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.

Find a Location

Who is running the clinical trial?

University of FloridaOTHER
1,340 Previous Clinical Trials
715,510 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,396 Total Patients Enrolled

Media Library

Diabetes Journey Clinical Trial Eligibility Overview. Trial Name: NCT04404556 — N/A
Type 1 Diabetes Research Study Groups: Diabetes Journey, Enhanced Standard of Care
Type 1 Diabetes Clinical Trial 2023: Diabetes Journey Highlights & Side Effects. Trial Name: NCT04404556 — N/A
Diabetes Journey 2023 Treatment Timeline for Medical Study. Trial Name: NCT04404556 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment admit individuals over a quarter-century of age?

"This clinical trial is enlisting participants of teenage age, ranging from 13 to 17 years old."

Answered by AI

Is there currently an opportunity for individuals to participate in this experiment?

"Affirmative, according to clinicaltrials.gov this study is actively recruiting patients with a start date of August 10th 2020 and recent adjustments made on October 3rd 2022. 256 people are being recruited between two separate locations."

Answered by AI

How many participants have registered to join this research study?

"Affirmative. The information hosted on clinicaltrials.gov suggests that this investigation is currently recruiting individuals, with the original post dating to August 10th 2020 and being updated most recently on October 3rd 2022. A total of 256 patients must be enrolled from 2 separate locations."

Answered by AI

Is my participation allowed in the current research?

"This trial seeks 256 adolescents aged 13 to 17 with elevated scores on the Barriers to Diabetes Adherence questionnaire (at least 3 out of 53 for Stress/Burnout and Time Pressure/Planning subscales)."

Answered by AI

What is the desired outcome of this experiment?

"The primary outcome measure to be evaluated over a 6-month follow up is the Stress/Burnout Subscale of the Barriers to Diabetes Adherence questionnaire-Youth Report. Secondary metrics include: daily insulin bolus count for pump users, carbohydrate entries per day for those using pumps and Quality of Life scores from Type 1 diabetes and Life - Youth Reports (range 0-100; higher scores signify improved quality)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Diabetes Journey: An Adolescent Adherence Barriers Intervention
2020. "Diabetes Journey: An Adolescent Adherence Barriers Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04404556.
~42 spots leftby Apr 2025
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