Adults 17 to 35, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Glycemic Control (HbA1c)Primary· 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
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
9.1
± 2.0
Peer Mentors
6.5
± 0.7
Usual Care
8.5
± 2.0
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
9.2
± 2.3
Usual Care
8.6
± 1.9
Time to First Adult Care VisitSecondary· End of Study at 12 Months Post-Randomization
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.
Group
Value
95% CI
DiaBetter Together Intervention
4.7
± 2.1
Usual Care
7.7
± 2.9
Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)Secondary· Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
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 p
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
3.8
± 0.7
Usual Care
4.0
± 0.6
Peer Mentors
4.1
± 0.5
6 months
Group
Value
95% CI
DiaBetter Together Intervention
4.0
± 0.7
Usual Care
3.9
± 0.7
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
3.9
± 0.7
Usual Care
3.9
± 0.6
Peer Mentors
4.1
± 0.5
Health-Related Quality of Life (Type 1 Diabetes and Life)Secondary· Baseline and End of Study at 12 Months Post-Randomization
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
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
65.5
± 15.8
Usual Care
66.7
± 15.4
Peer Mentors
65.6
± 12.5
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
68.4
± 16.0
Usual Care
63.0
± 14.6
Peer Mentors
61.6
± 14.5
Diabetes Strengths (Diabetes Strengths and Resilience Measure)Secondary· Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
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 f
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
50.4
± 10.1
Usual Care
50.0
± 9.3
6 months
Group
Value
95% CI
DiaBetter Together Intervention
52.1
± 9.2
Usual Care
49.7
± 9.4
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
52.8
± 8.6
Usual Care
50.1
± 10.4
Social Support (Brief 2-Way Social Support Scale)Secondary· Baseline & End of Study at 12 Months Post-Randomization
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.
Colle
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
50.2
± 7.0
Usual Care
46.5
± 9.0
Peer Mentors
52.1
± 4.5
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
50.3
± 7.9
Usual Care
47.1
± 10.0
Peer Mentors
52.7
± 5.4
Diabetes Distress (Diabetes Distress Scale for Adults With T1D)Secondary· Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
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 sco
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
2.3
± 1.0
Usual Care
2.0
± 0.7
Peer Mentors
1.8
± 0.6
6 months
Group
Value
95% CI
DiaBetter Together Intervention
1.8
± 0.8
Usual Care
2.0
± 0.7
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
1.7
± 0.7
Usual Care
2.0
± 0.8
Peer Mentors
1.8
± 0.6
Depressive Symptoms (PROMIS Short Form Depression 4a)Secondary· Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
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 scor
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
7.3
± 4.2
Usual Care
7.2
± 3.6
6 months
Group
Value
95% CI
DiaBetter Together Intervention
6.0
± 3.1
Usual Care
8.0
± 4.1
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
7.1
± 4.0
Usual Care
7.5
± 4.2
Emotional Support (PROMIS Short Form Emotional Support 4a)Secondary· Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
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.
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
16.7
± 4.3
Usual Care
16.8
± 3.8
6 months
Group
Value
95% CI
DiaBetter Together Intervention
17.5
± 3.1
Usual Care
16.8
± 3.7
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
17.6
± 2.7
Usual Care
16.4
± 3.8
Informational Support (PROMIS Short Form Informational Support 4a)Secondary· Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
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.
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
16.2
± 4.0
Usual Care
15.9
± 3.9
6 months
Group
Value
95% CI
DiaBetter Together Intervention
17.2
± 2.9
Usual Care
16.5
± 3.4
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
17.0
± 3.5
Usual Care
16.3
± 4.0
Social Isolation (PROMIS Short Form Social Isolation Item)Secondary· Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
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.
Baseline
Group
Value
95% CI
DiaBetter Together Intervention
2.6
± 1.3
Usual Care
2.5
± 1.1
6 months
Group
Value
95% CI
DiaBetter Together Intervention
2.2
± 1.1
Usual Care
2.8
± 1.3
End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
2.5
± 1.1
Usual Care
2.5
± 1.3
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)Secondary· Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
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'
Knowledge Scale - Baseline
Group
Value
95% CI
DiaBetter Together Intervention
3.9
± 1.0
Usual Care
3.9
± 1.1
Knowledge Scale - 6 months
Group
Value
95% CI
DiaBetter Together Intervention
4.3
± 0.8
Usual Care
4.0
± 1.2
Knowledge Scale - End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
4.4
± 0.8
Usual Care
4.0
± 1.1
Navigation Scale - Baseline
Group
Value
95% CI
DiaBetter Together Intervention
4.3
± 0.6
Usual Care
4.3
± 0.8
Navigation Scale - 6 months
Group
Value
95% CI
DiaBetter Together Intervention
4.5
± 0.6
Usual Care
4.3
± 0.8
Navigation Scale - End of Study at 12 Months Post-Randomization
Group
Value
95% CI
DiaBetter Together Intervention
4.7
± 0.5
Usual Care
4.4
± 0.7
Health Behaviors Scale - Baseline
Group
Value
95% CI
DiaBetter Together Intervention
4.8
± 0.6
Usual Care
4.7
± 1.0
Health Behaviors Scale - 6 months
Group
Value
95% CI
DiaBetter Together Intervention
4.8
± 0.4
Usual Care
4.7
± 0.9
Sponsor's own 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 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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Baylor College of Medicine
Last refreshed: 16 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04247620.