Trial Outcomes & Findings for Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D) (NCT NCT05413239)
NCT ID: NCT05413239
Last Updated: 2026-03-12
Results Overview
CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
217 participants
Primary outcome timeframe
0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis)
Results posted on
2026-03-12
Participant Flow
217 participants provided informed consent and 191 were randomized.
26 participants consented but were not randomized (18 did not complete baseline data, 5 had an ineligible central lab A1c, 2 withdrew, and 1 was a sibling of a randomized participant)
Participant milestones
| Measure |
Intervention Group
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
|
Control Group
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
96
|
|
Overall Study
COMPLETED
|
86
|
85
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)
Baseline characteristics by cohort
| Measure |
Intervention Group
n=95 Participants
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
|
Control Group
n=96 Participants
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.6 years
STANDARD_DEVIATION 3.6 • n=9 Participants
|
19.9 years
STANDARD_DEVIATION 3.3 • n=9 Participants
|
19.8 years
STANDARD_DEVIATION 3.4 • n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=9 Participants
|
72 Participants
n=9 Participants
|
149 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=9 Participants
|
12 Participants
n=9 Participants
|
21 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
20 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=9 Participants
|
89 Participants
n=9 Participants
|
171 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Male
|
54 Participants
n=9 Participants
|
39 Participants
n=9 Participants
|
93 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Female
|
40 Participants
n=9 Participants
|
56 Participants
n=9 Participants
|
96 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Nonbinary or other
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis)Population: Some participants did not have CGM data at some time points, and thus there are some missing data.
CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group.
Outcome measures
| Measure |
Intervention Group
n=95 Participants
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
|
Control Group
n=96 Participants
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
|---|---|---|
|
Time in Range (TIR)
Month 0
|
50.1 Percent of time
Standard Deviation 17.2
|
47.2 Percent of time
Standard Deviation 16.3
|
|
Time in Range (TIR)
Month 3
|
53.8 Percent of time
Standard Deviation 14.9
|
50.3 Percent of time
Standard Deviation 15.0
|
|
Time in Range (TIR)
Month 6
|
56.5 Percent of time
Standard Deviation 12.6
|
49.9 Percent of time
Standard Deviation 14.3
|
|
Time in Range (TIR)
Month 12
|
55.7 Percent of time
Standard Deviation 13.1
|
52.9 Percent of time
Standard Deviation 15.5
|
|
Time in Range (TIR)
Month 9
|
56.0 Percent of time
Standard Deviation 13.6
|
50.3 Percent of time
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)Population: Some participants did not complete the central lab A1c at some time points, and thus there are some missing data.
A1c will be assessed every 6 months. Blood samples will be collected locally using uniform procedures and sent to the central laboratory at the University of Minnesota for analysis. Change in A1c from 0 to 12 months will be compared within and between the intervention group and control group.
Outcome measures
| Measure |
Intervention Group
n=94 Participants
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
|
Control Group
n=94 Participants
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
|---|---|---|
|
A1c
A1c at Month 6
|
7.5 A1c %
Standard Deviation 0.9
|
7.9 A1c %
Standard Deviation 0.9
|
|
A1c
A1c at Month 0
|
7.9 A1c %
Standard Deviation 1.3
|
8.1 A1c %
Standard Deviation 1.2
|
|
A1c
A1c at Month 12
|
7.6 A1c %
Standard Deviation 0.8
|
7.9 A1c %
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)Population: Some participants did not complete surveys at some time points, and thus there are some missing data.
Diabetes distress will be assessed every 6 months using the validated Problem Areas in Diabetes - Pediatric survey (PAID-Peds). The PAID-Peds measures self-reported diabetes distress. The total score can range from 0 to 100, with higher scores indicating more diabetes distress. Change in diabetes distress from 0 to 12 months will be compared within and between the intervention group and control group.
Outcome measures
| Measure |
Intervention Group
n=95 Participants
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
|
Control Group
n=96 Participants
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
|---|---|---|
|
Diabetes Distress
Month 0 - PAID-Peds score
|
46.2 Score on a survey
Standard Deviation 21.7
|
51.6 Score on a survey
Standard Deviation 21.1
|
|
Diabetes Distress
Month 6 - PAID-Peds score
|
42.9 Score on a survey
Standard Deviation 20.1
|
48.2 Score on a survey
Standard Deviation 21.9
|
|
Diabetes Distress
Month 12 - PAID-Peds score
|
41.3 Score on a survey
Standard Deviation 21.2
|
46.7 Score on a survey
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)Population: Some participants did not complete surveys at some time points, and thus there are some missing data.
Attitudes toward diabetes device use will be assessed every 6 months using the validated Glucose Monitoring Satisfaction Survey for Type 1 Diabetes (GMSS-T1D) and the Diabetes Technology Attitudes Scale (DTAS). The GMSS-T1D measures satisfaction with glucose monitoring device (e.g., meter, continuous glucose monitoring system). The total score can range from 1 to 5 and was calculated by averaging all 15 survey items. A higher score indicates more satisfaction. The DTAS measures attitudes about diabetes devices and technology. The total score can range from 5 to 25 and was calculated by summing all 5 survey items. A higher score indicates more positive attitudes about diabetes devices and technology. Change in attitudes toward device use from 0 to 12 months will be compared within and between the intervention group and control group.
Outcome measures
| Measure |
Intervention Group
n=95 Participants
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
|
Control Group
n=96 Participants
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
|---|---|---|
|
Attitudes Toward Diabetes Device Use
GMSS Score at Month 0
|
3.97 Score on a survey
Standard Deviation .56
|
3.92 Score on a survey
Standard Deviation .56
|
|
Attitudes Toward Diabetes Device Use
DTAS Score at Month 12
|
22.58 Score on a survey
Standard Deviation 3.16
|
22.72 Score on a survey
Standard Deviation 2.62
|
|
Attitudes Toward Diabetes Device Use
GMSS Score at Month 6
|
3.98 Score on a survey
Standard Deviation .58
|
3.90 Score on a survey
Standard Deviation .60
|
|
Attitudes Toward Diabetes Device Use
GMSS Score at Month 12
|
3.93 Score on a survey
Standard Deviation .67
|
4.05 Score on a survey
Standard Deviation .54
|
|
Attitudes Toward Diabetes Device Use
DTAS Score at Month 0
|
22.24 Score on a survey
Standard Deviation 3.16
|
22.49 Score on a survey
Standard Deviation 2.75
|
|
Attitudes Toward Diabetes Device Use
DTAS Score at Month 6
|
22.56 Score on a survey
Standard Deviation 3.41
|
22.63 Score on a survey
Standard Deviation 2.63
|
Adverse Events
Intervention Group - Year 1 - Intervention Sessions
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group - Year 2 - No Intervention Sessions
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Year 1 - No Intervention Sessions
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Year 2 - Intervention Sessions
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Group - Year 1 - Intervention Sessions
n=95 participants at risk
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
|
Intervention Group - Year 2 - No Intervention Sessions
n=95 participants at risk
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
|
Control Group - Year 1 - No Intervention Sessions
n=96 participants at risk
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
Control Group - Year 2 - Intervention Sessions
n=96 participants at risk
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
|---|---|---|---|---|
|
Endocrine disorders
Hospitalization - Diabetes-related
|
2.1%
2/95 • From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
|
3.2%
3/95 • From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
|
7.3%
7/96 • From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
|
3.1%
3/96 • From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
|
|
General disorders
Hospitalization - Not diabetes-related
|
3.2%
3/95 • From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
|
3.2%
3/95 • From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
|
6.2%
6/96 • From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
|
6.2%
6/96 • From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place