DiaBetter Together for Young Adults With Type 1 Diabetes

NCT04247620 | Completed Phase 2 Results DMC

• 2 other identifiers: H-453601R01DK119246
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Peer Support; Adherence; Young Adult; Quality of Life; Transition; Resilience; Strengths-based; Sleep; COVID-19 Experiences

Outcome Measures

Primary Outcomes (1)

• Glycemic Control (HbA1c)

  HbA1c is the average blood glucose over 3-4 months. The American Diabetes Association recommends an HbA1c target of \<7.0%. HbA1c is collected via fingerstick/blood assay at routine diabetes visits and will be extracted from the medical record at each clinic visit during the study period. At Baseline and 12 months, HbA1c will be collected using the following methods: 1. Collection of most recent HbA1c from review of electronic medical chart (Texas Children's or Baylor College of Medicine) or medical records from outside provider (obtained with written permission from participant). 2. A dried blood spot at-home Hemoglobin A1c kit (Whatman 903 card, BD Microtainer HI-Flow Contact-Activated Lancet) will be mailed to the participant to complete and return to the study team for analysis on the Vitros 4600 HbA1c assay (correlated with the DCA 2000). Collected for young adult participants in both arms. Peer mentors self-reported HbA1c at baseline only.

  Baseline through 12-Month Post-Randomization

Secondary Outcomes (12)

• Time to First Adult Care Visit

  End of Study at 12 Months Post-Randomization

• Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)

  Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization

• Health-Related Quality of Life (Type 1 Diabetes and Life)

  Baseline and End of Study at 12 Months Post-Randomization

• Diabetes Strengths (Diabetes Strengths and Resilience Measure)

  Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization

• Social Support (Brief 2-Way Social Support Scale)

  Baseline & End of Study at 12 Months Post-Randomization

Study Arms (4)

DiaBetter Together Intervention

EXPERIMENTAL

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.

Behavioral: DiaBetter Together

Peer Mentors

OTHER

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.

Behavioral: Peer Mentor Delivery

Usual Care

NO 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.

Research Supplement

NO 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.

Interventions

DiaBetter Together 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).

DiaBetter Together Intervention

Peer Mentor Delivery 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.

Peer Mentors

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Children's National Research Institute: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 40750525 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Due to the COVID-19 pandemic, participant accrual was delayed and resulted in a smaller randomized sample size (n=100) than anticipated (n=150) Some measures listed as Outcome measures section (e.g., sleep, COVID-19 experiences , stressful events) were not primary or secondary outcomes of the trial, but rather descriptive or exploratory measures, and thus were not included in the Outcome Measures results.

Results Point of Contact

• Title: Dr. Marisa Hilliard
• Organization: Baylor College of Medicine

mehillia@bcm.edu

8328247209

Study Officials

• Marisa E Hilliard, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: December 15, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Receive copy of signed informed consent form upon signing
• Access Criteria: All participants receive copy of signed informed consent form

Locations

US (1)