Trial Outcomes & Findings for Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care (NCT NCT03734107)
NCT ID: NCT03734107
Last Updated: 2026-05-05
Results Overview
percentage of glycated hemoglobin (Hemoglobin A1c)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
8 months post-baseline
Results posted on
2026-05-05
Participant Flow
Letters were sent to 187 adolescents and young adults. Fifty-two participants completed all baseline procedures and were enrolled and randomized.
Participant milestones
| Measure |
PREP-DC Intervention
50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months).
Plan, Reflect, and Engage with Providers for Diabetes Care: Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
The final sample included 26 participants randomized to the intervention arm.
|
Standard Care Comparison
50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study.
The final sample included 26 participants randomized to the standard care arm.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants did not report.
Baseline characteristics by cohort
| Measure |
PREP-DC Intervention
n=26 Participants
50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months).
Plan, Reflect, and Engage with Providers for Diabetes Care: Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care.
26 participants were randomized to the PREP-DC Intervention group.
|
Standard Care Comparison
n=26 Participants
50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study.
26 participants were randomized to the Standard Care Comparison.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=52 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=26 Participants
|
25 Participants
n=26 Participants
|
51 Participants
n=52 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Age, Continuous
|
20.68 years
STANDARD_DEVIATION 1.1 • n=26 Participants
|
20.58 years
STANDARD_DEVIATION 1.2 • n=26 Participants
|
20.63 years
STANDARD_DEVIATION 1.1 • n=52 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=24 Participants • Two participants did not report.
|
12 Participants
n=26 Participants • Two participants did not report.
|
27 Participants
n=50 Participants • Two participants did not report.
|
|
Sex: Female, Male
Male
|
9 Participants
n=24 Participants • Two participants did not report.
|
14 Participants
n=26 Participants • Two participants did not report.
|
23 Participants
n=50 Participants • Two participants did not report.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
5 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=26 Participants
|
25 Participants
n=26 Participants
|
47 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
2 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=26 Participants
|
9 Participants
n=26 Participants
|
18 Participants
n=52 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=26 Participants
|
13 Participants
n=26 Participants
|
25 Participants
n=52 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
7 Participants
n=52 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
26 participants
n=26 Participants
|
52 participants
n=52 Participants
|
PRIMARY outcome
Timeframe: 8 months post-baselinePopulation: 37 participants had A1c data at final follow up.
percentage of glycated hemoglobin (Hemoglobin A1c)
Outcome measures
| Measure |
PREP-DC Intervention
n=17 Participants
50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months).
Plan, Reflect, and Engage with Providers for Diabetes Care: Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
26 participants were enrolled and randomized to the PREP-DC Intervention Group.
|
Standard Care Comparison
n=20 Participants
50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study.
26 participants were enrolled and randomized to the Standard Care Comparison group.
|
|---|---|---|
|
Hemoglobin A1c
|
7.988 A1c percentage
Standard Deviation 1.996
|
8.025 A1c percentage
Standard Deviation 1.345
|
PRIMARY outcome
Timeframe: 8 months post-baselinePopulation: There were missing data, which account for the discrepancy in participants at 8 months post-baseline. Additionally, some participants did not transition to adult diabetes care during the study period.
Number of days between the last visit in pediatric diabetes care and the first visit in adult diabetes care (reported as number of days).
Outcome measures
| Measure |
PREP-DC Intervention
n=11 Participants
50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months).
Plan, Reflect, and Engage with Providers for Diabetes Care: Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
26 participants were enrolled and randomized to the PREP-DC Intervention Group.
|
Standard Care Comparison
n=11 Participants
50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study.
26 participants were enrolled and randomized to the Standard Care Comparison group.
|
|---|---|---|
|
Number of Days to First Adult Diabetes Care Visit
|
94.72 Days
Standard Deviation 43.83
|
105.82 Days
Standard Deviation 27.48
|
PRIMARY outcome
Timeframe: 8 months post-baselinePopulation: There were some missing data, which account for the discrepancy in participants at 8 months post-baseline.
Participant report on the Diabetes Management Questionnaire (DMQ), a self-report measure of adherence to the diabetes care regimen. The DMQ consists of 20 items scored on a 0-4 Likert Scale. The measure has a total score; the mean score on all items is calculated and multiplied by 25 to arrive at the total score (possible range 0-100). A higher score indicates greater adherence to diabetes management.
Outcome measures
| Measure |
PREP-DC Intervention
n=22 Participants
50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months).
Plan, Reflect, and Engage with Providers for Diabetes Care: Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
26 participants were enrolled and randomized to the PREP-DC Intervention Group.
|
Standard Care Comparison
n=22 Participants
50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study.
26 participants were enrolled and randomized to the Standard Care Comparison group.
|
|---|---|---|
|
Adherence to the Diabetes Care Regimen
|
73.03 DMQ total score
Standard Deviation 15.75
|
71.68 DMQ total score
Standard Deviation 13.72
|
PRIMARY outcome
Timeframe: 8 months post-baselinePopulation: There were some missing data, which account for the discrepancy in participants at 8 months post-baseline.
Participant report and medical record review of reported diabetes-related hospitalizations for the duration of the study period. The total number of diabetes-related emergency department visits/hospitalizations is summed.
Outcome measures
| Measure |
PREP-DC Intervention
n=22 Participants
50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months).
Plan, Reflect, and Engage with Providers for Diabetes Care: Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
26 participants were enrolled and randomized to the PREP-DC Intervention Group.
|
Standard Care Comparison
n=22 Participants
50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study.
26 participants were enrolled and randomized to the Standard Care Comparison group.
|
|---|---|---|
|
Diabetes-related Hospitalizations
|
2 number of ED visits/hospitalizations
|
4 number of ED visits/hospitalizations
|
Adverse Events
PREP-DC Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Comparison
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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