MedDataX Logo

DiaBetter Together for Young Adults With Type 1 Diabetes

NCT ID: NCT04247620

Last Updated: 2025-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

DiaBetter Together is a strengths-based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The aims of this proposed randomized controlled trial are to evaluate the impact of the intervention on glycemic control (primary), time to first adult care visit, adherence, and psychosocial outcomes (secondary) in young adults with T1D after 12 months.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

DiaBetter Together is a strengths based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The study aims to optimize transition in T1D by leveraging and building on young adults' diabetes strengths, self-management skills, and social supports. This intervention will maximize protective processes that can facilitate optimal transition by training Peer Mentors (experienced young adults with T1D who have successfully established care in an adult setting) to provide relevant information about successful transition, teach strengths-based skills for managing transition-related challenges, share personal transition-related experiences, encourage young adults to access their social support network, and serve as a positive role model. Delivery of these strengths-based intervention components through a Peer Mentor has potential to reduce isolation, increase access to relevant information, and facilitate engagement with self-management and T1D care. This intervention is a complement to existing systems of care for young adults with T1D for 12 months as they leave the pediatric setting.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel two-group design will be used to evaluate the intervention among n=150 young adults randomly assigned to the peer support intervention or usual care (1:1). All young adults are randomized to either an intervention group, in which they all receive the same treatment in addition to usual diabetes care, or a control group, in which they receive usual diabetes care without the additional intervention. Young adult participants will be in the study for 12 months.

Peer Mentor participants (up to n=36) will deliver the intervention to young adults randomized to the intervention group, and their outcomes related to being a Peer Mentor will also be evaluated pre-post.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Participants will be aware of their assignment to intervention or control, as will the investigators. However, the person collecting HbA1c (primary outcome) at baseline and follow-up (12 mo) will not be aware of the participant's assignment in the intervention.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DiaBetter Together 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 Type EXPERIMENTAL

DiaBetter Together

Intervention Type BEHAVIORAL

Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult, including (a) teaching and modeling strengths-based skills for goal-setting, problem-solving, and stress management; (b) guiding participants in obtaining support from their social support network (e.g., family, friends); (c) developing a plan for accountability around diabetes management and follow-up in adult care; (d) sharing his/her transition experiences and strategies for successfully navigating the adult healthcare system; (e) discussing how to prioritize diabetes self-care; and (f) assisting them in accessing diabetes-related resources (e.g., local diabetes groups, apps, social media). Contact will be in-person, by phone, email, text message, and/or video, approximately weekly for first 3 mos, approximately biweekly for next 3 mos, and approximately monthly for last 6 mos (while COVID-19 safety recommendations are in place, in-person meetings will not occur).

Peer Mentors

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 Type OTHER

Peer Mentor Delivery

Intervention Type BEHAVIORAL

Peer Mentors deliver the intervention to multiple young adult participants, each for 12 months. Peer Mentors may take on one or more participants at a time, and Peer Mentors may stay in their role in the study (delivering the intervention) for 1-3 years.

Usual Care

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 Type NO_INTERVENTION

No interventions assigned to this group

Research Supplement

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DiaBetter Together

Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult, including (a) teaching and modeling strengths-based skills for goal-setting, problem-solving, and stress management; (b) guiding participants in obtaining support from their social support network (e.g., family, friends); (c) developing a plan for accountability around diabetes management and follow-up in adult care; (d) sharing his/her transition experiences and strategies for successfully navigating the adult healthcare system; (e) discussing how to prioritize diabetes self-care; and (f) assisting them in accessing diabetes-related resources (e.g., local diabetes groups, apps, social media). Contact will be in-person, by phone, email, text message, and/or video, approximately weekly for first 3 mos, approximately biweekly for next 3 mos, and approximately monthly for last 6 mos (while COVID-19 safety recommendations are in place, in-person meetings will not occur).

Intervention Type BEHAVIORAL

Peer Mentor Delivery

Peer Mentors deliver the intervention to multiple young adult participants, each for 12 months. Peer Mentors may take on one or more participants at a time, and Peer Mentors may stay in their role in the study (delivering the intervention) for 1-3 years.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* has a diagnosis of type 1 diabetes of at least 1 year
* currently receiving care at a Texas Children's Hospital Diabetes Care Center location
* is between the ages of 17-25 years at enrollment
* exhibits fluency in reading/speaking English
* their endocrine provider confirmed plans to transfer to adult provider in the next 6 months


* was diagnosed with type 1 diabetes before age 18
* has a diagnosis of type 1 diabetes of at least 1 years
* is between the ages of 20-35 at enrollment
* has been previously treated in pediatric care and is currently treated in adult care
* demonstrated interest and ability to effectively deliver the peer intervention \&
* exhibits fluency in reading/speaking English

Exclusion Criteria

* serious medical, cognitive, or mental health comorbidity that would preclude ability to provide informed consent or participate in data collection or intervention



* serious medical, cognitive, or mental health comorbidity that would preclude ability to fulfill role or complete questionnaires.
Minimum Eligible Age

17 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marisa Hilliard

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marisa E Hilliard, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Macke CA, Carreon SA, Desai KR, Minard CG, Lyons SK, McKay S, Devaraj S, Streisand R, Tang T, Anderson BJ, Hilliard ME. COVID-19 vaccine uptake and attitudes in emerging adults with type 1 diabetes. Vaccine. 2025 Aug 13;61:127083. doi: 10.1016/j.vaccine.2025.127083. Epub 2025 Jul 31.

Reference Type DERIVED
PMID: 40750525 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01DK119246

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-45360

Identifier Type: -

Identifier Source: org_study_id