Trial Outcomes & Findings for Improving Diabetes in Emerging Adulthood (NCT NCT04066959)
NCT ID: NCT04066959
Last Updated: 2026-05-05
Results Overview
Hb1Ac will be obtained by using the Accubase A1c test kit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
Baseline/0 month, Treatment End/3 months, and Follow Up/6 months
Results posted on
2026-05-05
Participant Flow
Recruitment into the clinical trial began on 11/16/2020 and ended 07/31/2024. The primary recruitment locations were local endocrinology clinics and advertising with national (e.g., T1D Exchange) and local (e.g., universities) community-based organizations and social media.
The participant enrollment process consisted of informed consent/assent procedures, baseline data collection, and randomization to one of eight study arms. Of the 113 enrolled participants, 109 were randomized and 4 were not: 1 found to be ineligible (age) post-enrollment and 3 were never randomized due to research staff error.
Participant milestones
| Measure |
Question Prompt List (QPL)
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
|
Motivation Enhancement System (MES)
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
|
Text Message Reminders (TXT)
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
|
QPL & MES
Participants will receive the QPL and MES interventions as described above.
|
QPL & TXT
Participants will receive the QPL and TXT interventions as described above.
|
MES & TXT
Participants will receive the MES and TXT interventions as described above.
|
MES, QPL & TXT
Participants will receive the MES, QPL, and TXT interventions as described above.
|
Standard Medical Care
Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
10
|
16
|
12
|
14
|
17
|
11
|
14
|
|
Overall Study
COMPLETED
|
13
|
8
|
13
|
11
|
12
|
16
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
1
|
2
|
1
|
2
|
4
|
Reasons for withdrawal
| Measure |
Question Prompt List (QPL)
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
|
Motivation Enhancement System (MES)
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
|
Text Message Reminders (TXT)
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
|
QPL & MES
Participants will receive the QPL and MES interventions as described above.
|
QPL & TXT
Participants will receive the QPL and TXT interventions as described above.
|
MES & TXT
Participants will receive the MES and TXT interventions as described above.
|
MES, QPL & TXT
Participants will receive the MES, QPL, and TXT interventions as described above.
|
Standard Medical Care
Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
1
|
2
|
1
|
2
|
4
|
Baseline Characteristics
Improving Diabetes in Emerging Adulthood
Baseline characteristics by cohort
| Measure |
Question Prompt List (QPL)
n=15 Participants
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
|
Motivation Enhancement System (MES)
n=10 Participants
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
|
Text Message Reminders (TXT)
n=16 Participants
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
|
QPL & MES
n=12 Participants
Participants will receive the QPL and MES interventions as described above.
|
QPL & TXT
n=14 Participants
Participants will receive the QPL and TXT interventions as described above.
|
MES & TXT
n=17 Participants
Participants will receive the MES and TXT interventions as described above.
|
MES, QPL & TXT
n=11 Participants
Participants will receive the MES, QPL, and TXT interventions as described above.
|
Standard Medical Care
n=14 Participants
Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
20.6 years
STANDARD_DEVIATION 2.6 • n=54 Participants
|
20.4 years
STANDARD_DEVIATION 3.0 • n=60 Participants
|
21.9 years
STANDARD_DEVIATION 2.6 • n=114 Participants
|
21.3 years
STANDARD_DEVIATION 3.4 • n=37 Participants
|
20.2 years
STANDARD_DEVIATION 3.2 • n=24 Participants
|
20.9 years
STANDARD_DEVIATION 3.1 • n=19 Participants
|
20.4 years
STANDARD_DEVIATION 2.7 • n=88 Participants
|
20.0 years
STANDARD_DEVIATION 3.1 • n=6 Participants
|
20.8 years
STANDARD_DEVIATION 2.9 • n=15 Participants
|
|
Sex/Gender, Customized
Participant-described Gender Identity · Female
|
8 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
15 Participants
n=114 Participants
|
8 Participants
n=37 Participants
|
10 Participants
n=24 Participants
|
10 Participants
n=19 Participants
|
7 Participants
n=88 Participants
|
7 Participants
n=6 Participants
|
72 Participants
n=15 Participants
|
|
Sex/Gender, Customized
Participant-described Gender Identity · Male
|
6 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
3 Participants
n=37 Participants
|
4 Participants
n=24 Participants
|
7 Participants
n=19 Participants
|
3 Participants
n=88 Participants
|
7 Participants
n=6 Participants
|
33 Participants
n=15 Participants
|
|
Sex/Gender, Customized
Participant-described Gender Identity · Transgender
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=15 Participants
|
|
Sex/Gender, Customized
Participant-described Gender Identity · Nonbinary
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
5 Participants
n=37 Participants
|
8 Participants
n=24 Participants
|
3 Participants
n=19 Participants
|
4 Participants
n=88 Participants
|
5 Participants
n=6 Participants
|
39 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
10 Participants
n=114 Participants
|
6 Participants
n=37 Participants
|
6 Participants
n=24 Participants
|
13 Participants
n=19 Participants
|
4 Participants
n=88 Participants
|
8 Participants
n=6 Participants
|
60 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
2 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=54 Participants
|
9 Participants
n=60 Participants
|
16 Participants
n=114 Participants
|
10 Participants
n=37 Participants
|
14 Participants
n=24 Participants
|
14 Participants
n=19 Participants
|
10 Participants
n=88 Participants
|
13 Participants
n=6 Participants
|
101 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline/0 month, Treatment End/3 months, and Follow Up/6 monthsPopulation: Missing data resulting from participant withdrawal or incomplete HbA1c test kits
Hb1Ac will be obtained by using the Accubase A1c test kit.
Outcome measures
| Measure |
Question Prompt List (QPL)
n=13 Participants
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
|
Motivation Enhancement System (MES)
n=9 Participants
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
|
Text Message Reminders (TXT)
n=13 Participants
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
|
QPL & MES
n=10 Participants
Participants will receive the QPL and MES interventions as described above.
|
QPL & TXT
n=13 Participants
Participants will receive the QPL and TXT interventions as described above.
|
MES & TXT
n=15 Participants
Participants will receive the MES and TXT interventions as described above.
|
MES, QPL & TXT
n=10 Participants
Participants will receive the MES, QPL, and TXT interventions as described above.
|
Standard Medical Care
n=13 Participants
Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
|
|---|---|---|---|---|---|---|---|---|
|
Hemoglobin A1c
Baseline / 0 Months
|
9.6 Percentage (%) of glycated hemoglobin
Standard Deviation 2.0
|
9.8 Percentage (%) of glycated hemoglobin
Standard Deviation 2.5
|
8.5 Percentage (%) of glycated hemoglobin
Standard Deviation 1.1
|
10.9 Percentage (%) of glycated hemoglobin
Standard Deviation 2.1
|
9.6 Percentage (%) of glycated hemoglobin
Standard Deviation 2.2
|
9.1 Percentage (%) of glycated hemoglobin
Standard Deviation 1.6
|
9.6 Percentage (%) of glycated hemoglobin
Standard Deviation 2.7
|
9.7 Percentage (%) of glycated hemoglobin
Standard Deviation 1.9
|
|
Hemoglobin A1c
Treatment End / 3 Months
|
10.0 Percentage (%) of glycated hemoglobin
Standard Deviation 3.3
|
10.2 Percentage (%) of glycated hemoglobin
Standard Deviation 2.8
|
8.4 Percentage (%) of glycated hemoglobin
Standard Deviation 1.0
|
10.3 Percentage (%) of glycated hemoglobin
Standard Deviation 2.7
|
9.5 Percentage (%) of glycated hemoglobin
Standard Deviation 1.3
|
8.9 Percentage (%) of glycated hemoglobin
Standard Deviation 1.7
|
9.9 Percentage (%) of glycated hemoglobin
Standard Deviation 3.0
|
9.3 Percentage (%) of glycated hemoglobin
Standard Deviation 1.8
|
|
Hemoglobin A1c
Follow Up / 6 Months
|
10.5 Percentage (%) of glycated hemoglobin
Standard Deviation 3.6
|
10.2 Percentage (%) of glycated hemoglobin
Standard Deviation 2.7
|
8.6 Percentage (%) of glycated hemoglobin
Standard Deviation 1.9
|
10.0 Percentage (%) of glycated hemoglobin
Standard Deviation 2.3
|
9.3 Percentage (%) of glycated hemoglobin
Standard Deviation 1.7
|
9.3 Percentage (%) of glycated hemoglobin
Standard Deviation 2.0
|
9.7 Percentage (%) of glycated hemoglobin
Standard Deviation 2.7
|
9.7 Percentage (%) of glycated hemoglobin
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline/0 month, Treatment End/3 months, and Follow Up/6 monthsThe Diabetes Management Scale (DMS) is a self-report measure of diabetes illness management assessing a broad range of diabetes management behaviors, including insulin management, dietary management, blood glucose monitoring, and symptom response with good internal consistency (α=.74 to .84). Ten items ask "What percent of the time do you (diabetes care task)?" with a response scale of 0-100% where higher scores indicate greater (better) diabetes management. A total score, ranging form 0-100%, is obtained by calculating the average response across ten items to reflect overall management behavior.
Outcome measures
| Measure |
Question Prompt List (QPL)
n=15 Participants
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
|
Motivation Enhancement System (MES)
n=10 Participants
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
|
Text Message Reminders (TXT)
n=16 Participants
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
|
QPL & MES
n=12 Participants
Participants will receive the QPL and MES interventions as described above.
|
QPL & TXT
n=14 Participants
Participants will receive the QPL and TXT interventions as described above.
|
MES & TXT
n=17 Participants
Participants will receive the MES and TXT interventions as described above.
|
MES, QPL & TXT
n=11 Participants
Participants will receive the MES, QPL, and TXT interventions as described above.
|
Standard Medical Care
n=14 Participants
Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
|
|---|---|---|---|---|---|---|---|---|
|
Diabetes Management Scale
Baseline / 0 Months
|
69.81 Percentage score (%)
Standard Deviation 16.76
|
33.17 Percentage score (%)
Standard Deviation 16.78
|
72.19 Percentage score (%)
Standard Deviation 16.40
|
58.32 Percentage score (%)
Standard Deviation 19.95
|
67.12 Percentage score (%)
Standard Deviation 14.12
|
68.95 Percentage score (%)
Standard Deviation 16.80
|
67.21 Percentage score (%)
Standard Deviation 14.68
|
67.27 Percentage score (%)
Standard Deviation 13.86
|
|
Diabetes Management Scale
Post-Treatment / 3 Months
|
76.55 Percentage score (%)
Standard Deviation 16.41
|
72.10 Percentage score (%)
Standard Deviation 14.65
|
75.29 Percentage score (%)
Standard Deviation 14.35
|
68.67 Percentage score (%)
Standard Deviation 16.23
|
70.59 Percentage score (%)
Standard Deviation 12.80
|
70.48 Percentage score (%)
Standard Deviation 14.22
|
76.97 Percentage score (%)
Standard Deviation 11.99
|
72.78 Percentage score (%)
Standard Deviation 12.63
|
|
Diabetes Management Scale
Follow Up / 6 Months
|
72.06 Percentage score (%)
Standard Deviation 18.60
|
73.46 Percentage score (%)
Standard Deviation 10.91
|
73.43 Percentage score (%)
Standard Deviation 11.73
|
68.94 Percentage score (%)
Standard Deviation 15.48
|
75.13 Percentage score (%)
Standard Deviation 11.86
|
71.95 Percentage score (%)
Standard Deviation 18.36
|
78.49 Percentage score (%)
Standard Deviation 13.97
|
74.93 Percentage score (%)
Standard Deviation 12.00
|
Adverse Events
Question Prompt List (QPL)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Motivation Enhancement System (MES)
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Text Message Reminders (TXT)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
QPL & MES
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
QPL & TXT
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
MES & TXT
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
MES, QPL & TXT
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard Medical Care
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Question Prompt List (QPL)
n=15 participants at risk
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
|
Motivation Enhancement System (MES)
n=10 participants at risk
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
|
Text Message Reminders (TXT)
n=16 participants at risk
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
|
QPL & MES
n=12 participants at risk
Participants will receive the QPL and MES interventions as described above.
|
QPL & TXT
n=14 participants at risk
Participants will receive the QPL and TXT interventions as described above.
|
MES & TXT
n=17 participants at risk
Participants will receive the MES and TXT interventions as described above.
|
MES, QPL & TXT
n=11 participants at risk
Participants will receive the MES, QPL, and TXT interventions as described above.
|
Standard Medical Care
n=14 participants at risk
Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
|
|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Diabetic Ketoacidosis (DKA)
|
20.0%
3/15 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
10.0%
1/10 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/16 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
8.3%
1/12 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
7.1%
1/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
5.9%
1/17 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/11 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
|
Endocrine disorders
Diabetes-related unscheduled visit
|
6.7%
1/15 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
50.0%
5/10 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
31.2%
5/16 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
8.3%
1/12 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
7.1%
1/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
29.4%
5/17 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
27.3%
3/11 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
21.4%
3/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
|
Psychiatric disorders
Psychiatric emergency
|
0.00%
0/15 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/10 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
6.2%
1/16 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
8.3%
1/12 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
5.9%
1/17 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/11 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
|
General disorders
Non-diabetes health problem
|
0.00%
0/15 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
30.0%
3/10 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
6.2%
1/16 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/12 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
14.3%
2/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
17.6%
3/17 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
9.1%
1/11 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
7.1%
1/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
Other adverse events
| Measure |
Question Prompt List (QPL)
n=15 participants at risk
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
|
Motivation Enhancement System (MES)
n=10 participants at risk
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
|
Text Message Reminders (TXT)
n=16 participants at risk
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
|
QPL & MES
n=12 participants at risk
Participants will receive the QPL and MES interventions as described above.
|
QPL & TXT
n=14 participants at risk
Participants will receive the QPL and TXT interventions as described above.
|
MES & TXT
n=17 participants at risk
Participants will receive the MES and TXT interventions as described above.
|
MES, QPL & TXT
n=11 participants at risk
Participants will receive the MES, QPL, and TXT interventions as described above.
|
Standard Medical Care
n=14 participants at risk
Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
|
|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Non-Emergency Diabetes-Related Event
|
13.3%
2/15 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
30.0%
3/10 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
6.2%
1/16 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
16.7%
2/12 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
7.1%
1/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
11.8%
2/17 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
9.1%
1/11 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
7.1%
1/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
|
Psychiatric disorders
Non-Emergency Mental Health Condition
|
6.7%
1/15 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/10 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
25.0%
4/16 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/12 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
29.4%
5/17 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
36.4%
4/11 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
21.4%
3/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
|
General disorders
Non-Diabetes Related Event
|
6.7%
1/15 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
10.0%
1/10 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
18.8%
3/16 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/12 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
14.3%
2/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
17.6%
3/17 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
9.1%
1/11 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
21.4%
3/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
|
General disorders
Behavioral / Social Events
|
6.7%
1/15 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
10.0%
1/10 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
6.2%
1/16 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/12 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/17 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
9.1%
1/11 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
0.00%
0/14 • AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place