DiaBetter Together for Young Adults With Type 1 Diabetes

Baylor College of Medicine

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Behavioral: DiaBetter Together; Behavioral: Peer Mentor Delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04247620

1R01DK119246 (U.S. NIH Grant/Contract)

H-45360

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 144 patients

Sex: All

Ages: 17 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Young Adult Inclusion/Exclusion Criteria

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

Exclusion Criteria:

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

Peer Mentor Inclusion/Exclusion Criteria

Inclusion Criteria:

• 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 fulfill role or complete questionnaires.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

144 participants in 4 patient groups

DiaBetter Together Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: DiaBetter Together

Peer Mentors

Other group

Description:

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.

Treatment:

Behavioral: Peer Mentor Delivery

Usual Care

No Intervention group

Description:

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.

Research Supplement

No Intervention group

Description:

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.