Type 1 DiabetesPhase 2DiaBetterNCT04247620
DiaBetter Together for Young Adults With Type 1 Diabetes
A Phase 2 study testing DiaBetter Together and Peer Mentor Delivery in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 35 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- DiaBetter Together and Peer Mentor Delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
- serious medical, cognitive, or mental health comorbidity that would preclude ability to fulfill role or complete questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DiaBetter Together: A Strengths-based, Peer Mentor Transition RCT for Young Adults With Type 1 Diabetes
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.
Read the detailed 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.
- Conditions
- Type 1 Diabetes
- Being tested
- DiaBetter Together, Peer Mentor Delivery
- Keywords
- Peer Support, Adherence, Young Adult, Quality of Life, Transition, Resilience, Strengths-based, Sleep, COVID-19 Experiences
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaBetter TogetherBehavioural
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 Mentor DeliveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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).
- 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.
Measured: Baseline through 12-Month Post-Randomization
Secondary outcomes (12)
Time to First Adult Care Visit
Time will start on the date of the last pediatric care visit (may differ from date of enrollment in study). The event of interest is the date of the first adult care visit. Participants who do not follow-up with an adult care provider within 12 months of the last pediatric visit will be censored for the event at the 12-month time point.
Collected for young adult participants in both arms, not Peer Mentors.
Measured: End of Study at 12 Months Post-Randomization
Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)
The Self-Care Inventory-Updated (SCI-U) is a 8-item measure that asks respondents the frequency with which they completed diabetes self-management tasks in the past 1-2 months. Item responses range from (1) Never to (5) Always, higher scores = higher adherence. A total score is calculated by summing and averaging all items, with no subscales. The minimum possible score is 8 and the maximum possible score is 40. Higher scores indicate higher engagement in diabetes self-management behaviors.
Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study).
Measured: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Health-Related Quality of Life (Type 1 Diabetes and Life)
The Type 1 Diabetes and Life (T1DAL) measure assesses diabetes-specific health-related quality of life. Participants will complete the T1DAL version for their age (Adolescent: 12-17, 23 items; Young Adult: 18-25, 27 items; Adult-1: 26-45, 27 items), which asks respondents to rate the degree to which each item is true about their everyday quality of life with diabetes. Items responses range from 1 (not at all true) to 5 (very true). Total scores are calculated by reverse-scoring items as indicated in the measure development paper instructions, then calculating a mean score and multiplying by 25 to convert the scores to a 100 point scale. The lowest possible total score is 0 and the highest possible total score is 100. Higher total scores = better T1D-specific health-related quality of life overall.
Collected for young adult participants in both arms (baseline and 12 mo) and Peer Mentors (pre- and post-involvement in study).
Measured: Baseline and End of Study at 12 Months Post-Randomization
Diabetes Strengths (Diabetes Strengths and Resilience Measure)
The Diabetes Strengths and Resilience (DSTAR) measure assesses participants' self-perceptions about what they do well with diabetes (known as diabetes strengths). Participants will complete the Young Adult version of the DSTAR, which asks respondents to rate how often the items represent their experiences/perspectives about their diabetes strengths. Items responses range from 0 (never) to 4 (almost always). A total score is calculated by summing the 16 item responses. Lowest possible total score = 0, highest possible total score = 64. Higher total scores = more diabetes strengths.
Collected for young adult participants in both arms, not Peer Mentors.
Measured: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Social Support (Brief 2-Way Social Support Scale)
The Brief 2-Way Social Support Scale (Brief-2SSS) is a 12-item measure that assesses experiences of giving and receiving social support. There are 4 scales: giving emotional support, giving instrumental support, receiving emotional support, receiving instrumental support. Items responses range 0 (not at all) to 5 (always). Higher scores = higher perceived support.
Young adults complete all subscales at baseline and 12 months, and only the 2 "Receiving" subscales at 6 months. Peer Mentors completed all 4 subscales. A Total score (combined) is calculated by summing all items, Range 0-60.
Collected for young adult participants in both arms (baseline \& 12 mos) and Peer Mentors (pre- and post-involvement in study).
Measured: Baseline & End of Study at 12 Months Post-Randomization
Diabetes Distress (Diabetes Distress Scale for Adults With T1D)
The Diabetes Distress Scale for Adults with T1D (DDS-T1D) is a 28-item self-report scale that measures participants' experiences with distress related to living with diabetes. It assesses seven dimensions of distress: powerlessness, management distress, hypoglycemia distress, negative social perceptions, eating distress, physician distress, and friends/family distress. Items responses range from 1 (not a problem) to 6 (a very serious problem). The total DDS-T1 score is calculated by averaging the items . Min possible total score = 1, Max = 6. Higher scores = more diabetes distress; average score <2.0 = little/no distress, 2.0-2.9 = moderate distress, 3.0 or higher = high distress.
Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study).
Measured: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Depressive Symptoms (PROMIS Short Form Depression 4a)
The PROMIS Short Form Depression 4a consists of 4 items that are pulled from the PROMIS Depression Item Bank v1.0. These items assess how often the individual has been bothered by depression-related symptoms, including negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), and decreased positive affect and engagement (loss of interest, meaning, and purpose), over the last 7 days. Items responses range from 1 (never) to 5 (always). A total score is calculated by summing the items, ranging from 4-20. Higher scores = more depressive symptoms.
Collected for young adult participants in both arms, not Peer Mentors.
Measured: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Emotional Support (PROMIS Short Form Emotional Support 4a)
The PROMIS Short Form Emotional Support 4a assesses perceived feelings of being cared for and valued as a person and having supportive relationships. Participants respond to 4 items on a scale from 1(Never) to 5 (Always) . A total score is calculated by summing the items. The possible range is 4-20. Higher scores = more perceived emotional support.
Collected for young adult participants in both arms, not Peer Mentors.
Measured: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Informational Support (PROMIS Short Form Informational Support 4a)
The PROMIS Short Form Informational Support 4a assesses perceptions about the information or resources others provide to them (adequacy, availability, helpfulness). Participants respond to 4 items on a scale from 1(Never) to 5 (Always). A total score is calculated by summing the items. The possible range is 4-20. Higher scores = more perceived informational support.
Collected for young adult participants in both arms, not Peer Mentors.
Measured: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Social Isolation (PROMIS Short Form Social Isolation Item)
The PROMIS Short Form Social Isolation item is a single-item measure from the PROMIS item bank that assesses participants' feelings of being isolated from other people. There is no time frame for responding to this measure. Participants respond to 1 item on a scale from 1 (Never) to 5 (Always), which is equivalent to the total score (higher = more perceived isolation).
Collected for young adult participants in both arms (baseline, 6, \& 12 mos), not Peer Mentors.
Measured: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
The Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth (READDY) is a 46-item self-report scale that measures participants' preparation for the transition to adult diabetes care, including: knowledge of diabetes, navigation of diabetes care, management skills and behaviors, and insulin pump skills if applicable. Only 18 items from the 3 subscales [Knowledge (4 items - baseline and 12 mos only), Navigation (13 items, baseline, 6 and 12 mos), Health Behaviors (1 item, baseline and 12 mo only)] will be administered for this study. Items responses range from 0 (haven't thought about it) to 5 (yes, I can do this). For each subscale, a subscale score is calculated by averaging the items. Possible score range for each subscale = 1-5. Higher scores = higher readiness in each domain.
Collected for young adult participants in both arms (baseline, 6, \& 12 mos), not Peer Mentors.
Measured: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
General Quality of Life (Satisfaction With Life Scale)
The Satisfaction with Life Scale (SWLS) is a 5-item self-report scale that measures participants' perceptions about their life overall. Items responses range from 1 (strongly disagree) to 7 (strongly agree). A total score is calculated by summing the items. Possible score range = 5-35. Higher = greater overall satisfaction with life.
Collected for young adult participants in both arms (baseline and 12 mo), not Peer Mentors.
Measured: Baseline and End of Study at 12 Months Post-Randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start15 Dec 2020
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's National Research Institute
- Responsible party
- Principal investigator, Marisa Hilliard, Baylor College of Medicine
- Investigators
- Marisa E Hilliard, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247620
- Sponsor's protocol ID
- H-45360
- Other IDs
- 1R01DK119246
- Acronym
- DiaBetter
- Status last verified
- Dec 2025
- First submitted
- 28 Jan 2020
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants receive informed consent form, and other participant data is not returned to participant.
Publications
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.
PubMed 40750525
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiaBetter Together: A Strengths-based, Peer Mentor Transition RCT for Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04247620
- Acronym / sponsor ID
- DiaBetter / H-45360
- Conditions
- Type 1 Diabetes
- Keywords
- Peer Support, Adherence, Young Adult, Quality of Life, Transition, Resilience, Strengths-based, Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's National Research Institute
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DiaBetter Together Intervention | Experimental | Behavioral: DiaBetter TogetherYoung 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. |
| Peer Mentors | Other | Behavioral: Peer Mentor DeliveryPeer 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. |
| 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. |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
- serious medical, cognitive, or mental health comorbidity that would preclude ability to fulfill role or complete questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaBetter TogetherFollowing 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). | Behavioural | DiaBetter Together Intervention |
| Peer Mentor DeliveryPeer 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. | Behavioural | Peer Mentors |
Primary outcome
Glycemic Control (HbA1c)
Time frame: Baseline through 12-Month Post-Randomization
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.
12 secondary outcomes
Time to First Adult Care Visit
Time frame: End of Study at 12 Months Post-Randomization
Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Health-Related Quality of Life (Type 1 Diabetes and Life)
Time frame: Baseline and End of Study at 12 Months Post-Randomization
Diabetes Strengths (Diabetes Strengths and Resilience Measure)
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Social Support (Brief 2-Way Social Support Scale)
Time frame: Baseline & End of Study at 12 Months Post-Randomization
Diabetes Distress (Diabetes Distress Scale for Adults With T1D)
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Depressive Symptoms (PROMIS Short Form Depression 4a)
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Emotional Support (PROMIS Short Form Emotional Support 4a)
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Informational Support (PROMIS Short Form Informational Support 4a)
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Social Isolation (PROMIS Short Form Social Isolation Item)
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
General Quality of Life (Satisfaction With Life Scale)
Time frame: Baseline and End of Study at 12 Months Post-Randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40750525Macke 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.
- Individual participant dataSharing planned: Yes. Participants receive informed consent form, and other participant data is not returned to participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa E Hilliard, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DiaBetter Together and Peer Mentor Delivery in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (HbA1c) (time frame: Baseline through 12-Month Post-Randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04247620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.