Trial Outcomes & Findings for DiaBetter Together for Young Adults With Type 1 Diabetes (NCT NCT04247620)
NCT ID: NCT04247620
Last Updated: 2025-12-16
Results Overview
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.
COMPLETED
PHASE2
144 participants
Baseline through 12-Month Post-Randomization
2025-12-16
Participant Flow
115 young adults consented to the trial. Of those, 14 did not complete baseline data and were therefore not randomized, and 1 was withdrawn due to a change in eligibility. 29 peer mentors consented to the trial and completed baseline data.
Results reflect the number of participants who completed data. This differs from the protocol enrollment number, as some consented participants did not complete baseline data and thus were not randomized or followed for subsequent data collection. Following trial completion, a subset of 20 participants from the Usual Care group completed an additional week of data collection related to their experiences with sleep. No intervention was administered - data collection only.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
29
|
|
Overall Study
Sleep Supplement Participation
|
0
|
20
|
0
|
|
Overall Study
COMPLETED
|
44
|
48
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-reported health insurance type
Baseline characteristics by cohort
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Usual Care
n=50 Participants
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.
|
Peer Mentors
n=29 Participants
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.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.0 Years
STANDARD_DEVIATION 1.3 • n=6 Participants
|
19.9 Years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
25.1 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
21.1 Years
STANDARD_DEVIATION 2.9 • n=387 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=6 Participants
|
25 Participants
n=5 Participants
|
21 Participants
n=5 Participants
|
79 Participants
n=387 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=6 Participants
|
25 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
50 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · African American/Black, non-Hispanic
|
8 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · American Indian/Alaska Native, non-Hispanic
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Asian, non-Hispanic
|
1 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Hispanic
|
8 Participants
n=6 Participants
|
17 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · White, non-Hispanic
|
29 Participants
n=6 Participants
|
25 Participants
n=5 Participants
|
20 Participants
n=5 Participants
|
74 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Another or multiple
|
3 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=387 Participants
|
|
Insurance
Private or Commercial
|
27 Participants
n=6 Participants • Self-reported health insurance type
|
26 Participants
n=5 Participants • Self-reported health insurance type
|
27 Participants
n=5 Participants • Self-reported health insurance type
|
80 Participants
n=387 Participants • Self-reported health insurance type
|
|
Insurance
Public, County, Other, or No Insurance
|
18 Participants
n=6 Participants • Self-reported health insurance type
|
16 Participants
n=5 Participants • Self-reported health insurance type
|
2 Participants
n=5 Participants • Self-reported health insurance type
|
36 Participants
n=387 Participants • Self-reported health insurance type
|
|
Insurance
Unsure
|
5 Participants
n=6 Participants • Self-reported health insurance type
|
8 Participants
n=5 Participants • Self-reported health insurance type
|
0 Participants
n=5 Participants • Self-reported health insurance type
|
13 Participants
n=387 Participants • Self-reported health insurance type
|
|
Insulin delivery method, self-reported
Insulin Pump
|
27 Participants
n=6 Participants
|
29 Participants
n=5 Participants
|
25 Participants
n=5 Participants
|
81 Participants
n=387 Participants
|
|
Insulin delivery method, self-reported
Injections
|
23 Participants
n=6 Participants
|
21 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
48 Participants
n=387 Participants
|
|
Continuous glucose monitor use, self-reported
|
42 Participants
n=6 Participants
|
34 Participants
n=5 Participants
|
27 Participants
n=5 Participants
|
103 Participants
n=387 Participants
|
PRIMARY outcome
Timeframe: Baseline through 12-Month Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=29 Participants
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.
|
Usual Care
n=50 Participants
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.
|
|---|---|---|---|
|
Glycemic Control (HbA1c)
Baseline
|
9.1 Percentage of HbA1c
Standard Deviation 2.0
|
6.5 Percentage of HbA1c
Standard Deviation 0.7
|
8.5 Percentage of HbA1c
Standard Deviation 2.0
|
|
Glycemic Control (HbA1c)
End of Study at 12 Months Post-Randomization
|
9.2 Percentage of HbA1c
Standard Deviation 2.3
|
—
|
8.6 Percentage of HbA1c
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: End of Study at 12 Months Post-RandomizationPopulation: Time to adult care visit was unable to be collected for most trial participants
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=8 Participants
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.
|
Peer Mentors
n=4 Participants
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.
|
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.
|
|---|---|---|---|
|
Time to First Adult Care Visit
|
4.7 month
Standard Deviation 2.1
|
7.7 month
Standard Deviation 2.9
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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).
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
Usual Care
n=29 Participants
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.
|
|---|---|---|---|
|
Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)
6 months
|
4.0 scores on a scale
Standard Deviation 0.7
|
3.9 scores on a scale
Standard Deviation 0.7
|
—
|
|
Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)
End of Study at 12 Months Post-Randomization
|
3.9 scores on a scale
Standard Deviation 0.7
|
3.9 scores on a scale
Standard Deviation 0.6
|
4.1 scores on a scale
Standard Deviation 0.5
|
|
Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)
Baseline
|
3.8 scores on a scale
Standard Deviation 0.7
|
4.0 scores on a scale
Standard Deviation 0.6
|
4.1 scores on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline and End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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).
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
Usual Care
n=29 Participants
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.
|
|---|---|---|---|
|
Health-Related Quality of Life (Type 1 Diabetes and Life)
Baseline
|
65.5 scores on a scale
Standard Deviation 15.8
|
66.7 scores on a scale
Standard Deviation 15.4
|
65.6 scores on a scale
Standard Deviation 12.5
|
|
Health-Related Quality of Life (Type 1 Diabetes and Life)
End of Study at 12 Months Post-Randomization
|
68.4 scores on a scale
Standard Deviation 16.0
|
63.0 scores on a scale
Standard Deviation 14.6
|
61.6 scores on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
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.
|
|---|---|---|---|
|
Diabetes Strengths (Diabetes Strengths and Resilience Measure)
6 months
|
52.1 scores on a scale
Standard Deviation 9.2
|
49.7 scores on a scale
Standard Deviation 9.4
|
—
|
|
Diabetes Strengths (Diabetes Strengths and Resilience Measure)
Baseline
|
50.4 scores on a scale
Standard Deviation 10.1
|
50.0 scores on a scale
Standard Deviation 9.3
|
—
|
|
Diabetes Strengths (Diabetes Strengths and Resilience Measure)
End of Study at 12 Months Post-Randomization
|
52.8 scores on a scale
Standard Deviation 8.6
|
50.1 scores on a scale
Standard Deviation 10.4
|
—
|
SECONDARY outcome
Timeframe: Baseline & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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).
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
Usual Care
n=29 Participants
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.
|
|---|---|---|---|
|
Social Support (Brief 2-Way Social Support Scale)
Baseline
|
50.2 scores on a scale
Standard Deviation 7.0
|
46.5 scores on a scale
Standard Deviation 9.0
|
52.1 scores on a scale
Standard Deviation 4.5
|
|
Social Support (Brief 2-Way Social Support Scale)
End of Study at 12 Months Post-Randomization
|
50.3 scores on a scale
Standard Deviation 7.9
|
47.1 scores on a scale
Standard Deviation 10.0
|
52.7 scores on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition 1 missing value at baseline due to scoring rules, unable to calculate a total score due to missing data
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).
Outcome measures
| Measure |
DiaBetter Together Intervention
n=49 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
Usual Care
n=29 Participants
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.
|
|---|---|---|---|
|
Diabetes Distress (Diabetes Distress Scale for Adults With T1D)
Baseline
|
2.3 scores on a scale
Standard Deviation 1.0
|
2.0 scores on a scale
Standard Deviation 0.7
|
1.8 scores on a scale
Standard Deviation 0.6
|
|
Diabetes Distress (Diabetes Distress Scale for Adults With T1D)
6 months
|
1.8 scores on a scale
Standard Deviation 0.8
|
2.0 scores on a scale
Standard Deviation 0.7
|
—
|
|
Diabetes Distress (Diabetes Distress Scale for Adults With T1D)
End of Study at 12 Months Post-Randomization
|
1.7 scores on a scale
Standard Deviation 0.7
|
2.0 scores on a scale
Standard Deviation 0.8
|
1.8 scores on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
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.
|
|---|---|---|---|
|
Depressive Symptoms (PROMIS Short Form Depression 4a)
Baseline
|
7.3 scores on a scale
Standard Deviation 4.2
|
7.2 scores on a scale
Standard Deviation 3.6
|
—
|
|
Depressive Symptoms (PROMIS Short Form Depression 4a)
6 months
|
6.0 scores on a scale
Standard Deviation 3.1
|
8.0 scores on a scale
Standard Deviation 4.1
|
—
|
|
Depressive Symptoms (PROMIS Short Form Depression 4a)
End of Study at 12 Months Post-Randomization
|
7.1 scores on a scale
Standard Deviation 4.0
|
7.5 scores on a scale
Standard Deviation 4.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
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.
|
|---|---|---|---|
|
Emotional Support (PROMIS Short Form Emotional Support 4a)
6 months
|
17.5 scores on a scale
Standard Deviation 3.1
|
16.8 scores on a scale
Standard Deviation 3.7
|
—
|
|
Emotional Support (PROMIS Short Form Emotional Support 4a)
End of Study at 12 Months Post-Randomization
|
17.6 scores on a scale
Standard Deviation 2.7
|
16.4 scores on a scale
Standard Deviation 3.8
|
—
|
|
Emotional Support (PROMIS Short Form Emotional Support 4a)
Baseline
|
16.7 scores on a scale
Standard Deviation 4.3
|
16.8 scores on a scale
Standard Deviation 3.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
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.
|
|---|---|---|---|
|
Informational Support (PROMIS Short Form Informational Support 4a)
Baseline
|
16.2 scores on a scale
Standard Deviation 4.0
|
15.9 scores on a scale
Standard Deviation 3.9
|
—
|
|
Informational Support (PROMIS Short Form Informational Support 4a)
6 months
|
17.2 scores on a scale
Standard Deviation 2.9
|
16.5 scores on a scale
Standard Deviation 3.4
|
—
|
|
Informational Support (PROMIS Short Form Informational Support 4a)
End of Study at 12 Months Post-Randomization
|
17.0 scores on a scale
Standard Deviation 3.5
|
16.3 scores on a scale
Standard Deviation 4.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
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.
|
|---|---|---|---|
|
Social Isolation (PROMIS Short Form Social Isolation Item)
Baseline
|
2.6 scores on a scale
Standard Deviation 1.3
|
2.5 scores on a scale
Standard Deviation 1.1
|
—
|
|
Social Isolation (PROMIS Short Form Social Isolation Item)
6 months
|
2.2 scores on a scale
Standard Deviation 1.1
|
2.8 scores on a scale
Standard Deviation 1.3
|
—
|
|
Social Isolation (PROMIS Short Form Social Isolation Item)
End of Study at 12 Months Post-Randomization
|
2.5 scores on a scale
Standard Deviation 1.1
|
2.5 scores on a scale
Standard Deviation 1.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
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.
|
|---|---|---|---|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Knowledge Scale - Baseline
|
3.9 scores on a scale
Standard Deviation 1.0
|
3.9 scores on a scale
Standard Deviation 1.1
|
—
|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Knowledge Scale - 6 months
|
4.3 scores on a scale
Standard Deviation 0.8
|
4.0 scores on a scale
Standard Deviation 1.2
|
—
|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Knowledge Scale - End of Study at 12 Months Post-Randomization
|
4.4 scores on a scale
Standard Deviation 0.8
|
4.0 scores on a scale
Standard Deviation 1.1
|
—
|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Navigation Scale - Baseline
|
4.3 scores on a scale
Standard Deviation 0.6
|
4.3 scores on a scale
Standard Deviation 0.8
|
—
|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Navigation Scale - 6 months
|
4.5 scores on a scale
Standard Deviation 0.6
|
4.3 scores on a scale
Standard Deviation 0.8
|
—
|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Navigation Scale - End of Study at 12 Months Post-Randomization
|
4.7 scores on a scale
Standard Deviation 0.5
|
4.4 scores on a scale
Standard Deviation 0.7
|
—
|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Health Behaviors Scale - Baseline
|
4.8 scores on a scale
Standard Deviation 0.6
|
4.7 scores on a scale
Standard Deviation 1.0
|
—
|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Health Behaviors Scale - 6 months
|
4.8 scores on a scale
Standard Deviation 0.4
|
4.7 scores on a scale
Standard Deviation 0.9
|
—
|
|
Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
Health Behaviors Scale - End of Study at 12 Months Post-Randomization
|
4.9 scores on a scale
Standard Deviation 0.4
|
4.6 scores on a scale
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and End of Study at 12 Months Post-RandomizationPopulation: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
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.
Outcome measures
| Measure |
DiaBetter Together Intervention
n=50 Participants
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.
|
Peer Mentors
n=50 Participants
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.
|
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.
|
|---|---|---|---|
|
General Quality of Life (Satisfaction With Life Scale)
Baseline
|
23.1 scores on a scale
Standard Deviation 8.1
|
24.0 scores on a scale
Standard Deviation 6.7
|
—
|
|
General Quality of Life (Satisfaction With Life Scale)
End of Study at 12 Months Post-Randomization
|
24.0 scores on a scale
Standard Deviation 8.5
|
22. scores on a scale
Standard Deviation 6.8
|
—
|
Adverse Events
DiaBetter Together Intervention
Peer Mentors
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place