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Peer Support for Type 1 Diabetes (DiaBetter Trial)
Phase 2
Waitlist Available
Led By Marisa E Hilliard, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Young Adult Inclusion/
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-month post-randomization, & 12-month post-randomization
Awards & highlights
Summary
This trial aims to study the effects of peer support on young adults with type 1 diabetes transitioning to adult care. The goal is to see if this intervention can help with glycemic control, adherence, and psychosocial outcomes.
Who is the study for?
This trial is for young adults aged 17-25 with Type 1 Diabetes, specifically during their transition from pediatric to adult diabetes care. Participants will be paired with trained Peer Mentors aged 20-35.
What is being tested?
The 'DiaBetter Together' program pairs young adults with peer mentors to help manage their diabetes. The study checks if this support improves blood sugar control and other health outcomes over a year.
What are the potential side effects?
Since the intervention involves peer support rather than medication, there are no direct medical side effects; however, participants may experience varying psychological impacts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6-month post-randomization, & 12-month post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-month post-randomization, & 12-month post-randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Glycemic Control (HbA1c)
Secondary study objectives
COVID-19 Experiences (COVID-19 Experiences Questionnaire for Young Adults with T1D)
COVID-19 Protective Behaviors (Oelsner MESA COVID-19 - Revised)
Depressive Symptoms (PROMIS Short Form Depression 4a)
+14 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Peer MentorsExperimental Treatment1 Intervention
Peer Mentors will deliver the DiaBetter Together intervention and will also be enrolled as study participants to permit assessment of their own outcomes from delivering this peer support intervention to younger people with diabetes. Peer Mentors will be experienced young adults with T1D who have transferred to adult diabetes care.
Group II: DiaBetter Together InterventionExperimental Treatment1 Intervention
Young Adult participants with type 1 diabetes (ages 17-25) who are approaching transfer from pediatric to adult care will be randomized to either the DiaBetter Together Intervention group or the Usual Care group. After randomization to the intervention group, young adults will be assigned a Peer Mentor. Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult. In both conditions, participation in this study will not impact participants' ability to contact the pediatric TCH diabetes care team or any other medical services to receive medical care.
Group III: Usual CareActive Control1 Intervention
Participants randomized to the comparison condition will receive usual diabetes care only, without additional intervention through the study. They will participate in all study activities related to data collection, but will not receive the Peer Mentor intervention. In both conditions, participation in this study will not impact participants' ability to contact the pediatric TCH diabetes care team or any other medical services to receive medical care.
Group IV: Research SupplementActive Control1 Intervention
Following completion of 12-month data collection, a subset of participants from the Usual Care group will have the opportunity to complete an optional and additional week (7 days) of follow-up data collection to characterize general and diabetes-specific sleep patterns.
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,285 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,409 Previous Clinical Trials
4,324,765 Total Patients Enrolled
Children's National Research InstituteOTHER
218 Previous Clinical Trials
257,766 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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