Trial Outcomes & Findings for Sweetgoals for Type 1 Diabetes (NCT NCT04646473)
NCT ID: NCT04646473
Last Updated: 2026-08-13
Results Overview
Estimated mean change (slope) in percent glycated hemoglobin per each 6 month interval from Baseline to Month 12 were obtained from a growth curve analysis using maximum likelihood estimation to account for missing data. All randomized participants were utilized in the model (ITT analysis).
COMPLETED
NA
300 participants
From Baseline to Month 12
2026-08-13
Participant Flow
Recruitment via social media. Enrolled from July 25, 2021 to 03/25/2024.
Participant milestones
| Measure |
Sweetgoals App
Sweetgoals app
|
Sweetgoals App, Incentives
Sweetgoals app, incentives
|
Sweetgoals App, Coaching
Sweetgoals app, coaching
|
Sweetgoals App, Incentives, Coaching
Sweetgoals app, incentives, coaching
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
75
|
75
|
|
Overall Study
COMPLETED
|
69
|
73
|
68
|
71
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sweetgoals for Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Sweetgoals App, Incentives
n=75 Participants
Sweetgoals app, incentives
|
Sweetgoals App, Coaching
n=75 Participants
Sweetgoals app, coaching
|
Sweetgoals App, Incentives, Coaching
n=75 Participants
Sweetgoals app, incentives, coaching
|
Total
n=300 Participants
Total of all reporting groups
|
Sweetgoals App
n=75 Participants
Sweetgoals app
|
|---|---|---|---|---|---|
|
Age, Continuous
|
23.55 years
STANDARD_DEVIATION 3.08 • n=1 Participants
|
23.67 years
STANDARD_DEVIATION 2.95 • n=1 Participants
|
23.37 years
STANDARD_DEVIATION 2.88 • n=2 Participants
|
23.40 years
STANDARD_DEVIATION 2.97
|
23.03 years
STANDARD_DEVIATION 2.97 • n=1 Participants
|
|
Sex/Gender, Customized
Female
|
53 Participants
n=1 Participants
|
50 Participants
n=1 Participants
|
50 Participants
n=2 Participants
|
204 Participants
|
51 Participants
n=1 Participants
|
|
Sex/Gender, Customized
Male
|
21 Participants
n=1 Participants
|
22 Participants
n=1 Participants
|
23 Participants
n=2 Participants
|
88 Participants
|
22 Participants
n=1 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
8 Participants
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=2 Participants
|
8 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
8 Participants
n=2 Participants
|
30 Participants
|
9 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=1 Participants
|
58 Participants
n=1 Participants
|
60 Participants
n=2 Participants
|
239 Participants
|
61 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
4 Participants
n=2 Participants
|
17 Participants
|
4 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
5 Participants
|
1 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
9 Participants
n=2 Participants
|
30 Participants
|
8 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=1 Participants
|
69 Participants
n=1 Participants
|
66 Participants
n=2 Participants
|
270 Participants
|
67 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
HbA1c
|
8.92 percent
STANDARD_DEVIATION 1.08 • n=1 Participants
|
8.82 percent
STANDARD_DEVIATION 1.50 • n=1 Participants
|
8.82 percent
STANDARD_DEVIATION 1.42 • n=2 Participants
|
8.84 percent
STANDARD_DEVIATION 1.31
|
8.80 percent
STANDARD_DEVIATION 1.22 • n=1 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Month 12Population: ITT population: all randomized participants. The decision to analyze all randomized participants together for aim 1, rather than separately by arm, assesses the main effect of time for these participants, all of whom received an active intervention. The decision to analyze all randomized participants together, rather than separately by arm, was pre-specified in the the Protocol/Statistical Analysis Plan for the purposes of assessing the main effect of time.
Estimated mean change (slope) in percent glycated hemoglobin per each 6 month interval from Baseline to Month 12 were obtained from a growth curve analysis using maximum likelihood estimation to account for missing data. All randomized participants were utilized in the model (ITT analysis).
Outcome measures
| Measure |
All Reporting Groups
n=300 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of both intervention factors, HbA1c measured at baseline and month 12.
|
Coaching
Coaching (Off) or Coaching (On)
|
|---|---|---|
|
Percent Glycated Hemoglobin/6 Months
|
-.311 Percent Glycated Hemoglobin/6 months
Interval -0.374 to -0.247
|
—
|
PRIMARY outcome
Timeframe: 12 months, controlling for baselinePopulation: ITT population: all randomized participants.
Estimated mean change from Baseline to Month 12 were obtained from a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the change in HbA1c at 12 months vs. baseline associated with the On level of the intervention condition relative to the Off level of the intervention condition.
Outcome measures
| Measure |
All Reporting Groups
n=300 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of both intervention factors, HbA1c measured at baseline and month 12.
|
Coaching
n=300 Participants
Coaching (Off) or Coaching (On)
|
|---|---|---|
|
Change in Hba1c at 12 Months, Main Effects of Each Intervention Component
|
0.118 Percent
Interval -0.029 to 0.306
|
0.005 Percent
Interval -0.146 to 0.161
|
SECONDARY outcome
Timeframe: At 12 months, controlling for baselinePopulation: ITT population: all randomized participants. This population was pre-specified in the the Protocol/Statistical Analysis Plan for the purposes of assessing the effects of glucose checking goal achievement on changes in glycated hemoglobin as part of the mediation model.
Estimated mean change from baseline to Month 12 was obtained from a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the change in HbA1c at 12 months from baseline associated with each additional day of glucose checking goal achievement during the 6-month intervention period.
Outcome measures
| Measure |
All Reporting Groups
n=300 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of both intervention factors, HbA1c measured at baseline and month 12.
|
Coaching
Coaching (Off) or Coaching (On)
|
|---|---|---|
|
Change in Percent Glycated Hemoglobin Per Day of Glucose Checking Goal Achievement
|
-0.071 % glycated hemoglobin/day per week
Interval -0.22 to 0.055
|
—
|
SECONDARY outcome
Timeframe: At 12 months, controlling for baselinePopulation: ITT population: all randomized participants. This population was pre-specified in the the Protocol/Statistical Analysis Plan for the purposes of assessing the effects of mealtime goal achievement on changes in glycated hemoglobin as part of the mediation model.
Estimated mean change from baseline to Month 12 was obtained from a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the change in HbA1c at 12 months from baseline associated with each additional day of mealtime goal achievement during the 6-month intervention period.
Outcome measures
| Measure |
All Reporting Groups
n=300 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of both intervention factors, HbA1c measured at baseline and month 12.
|
Coaching
Coaching (Off) or Coaching (On)
|
|---|---|---|
|
Change in Percent Glycated Hemoglobin Per Day of Mealtime Goal Achievement
|
-0.12 % glycated hemoglobin/day per week
Interval -0.203 to -0.04
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: ITT population: all randomized participants.
Estimated mean days per week meeting checking goal were obtained from a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the difference in the mean days per week the checking goal was met associated with the On level of each intervention condition relative to the Off level of the intervention condition.
Outcome measures
| Measure |
All Reporting Groups
n=300 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of both intervention factors, HbA1c measured at baseline and month 12.
|
Coaching
n=300 Participants
Coaching (Off) or Coaching (On)
|
|---|---|---|
|
Days Per Week Meeting Glucose Checking Goal During Intervention Period, Main Effects of Each Intervention Component
|
0.208 Days per week
Interval 0.029 to 0.399
|
0.103 Days per week
Interval -0.08 to 0.291
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: ITT population: all randomized participants.
Estimated mean days per week meeting mealtime goal were obtained from a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the difference in the mean days per week the goal was met associated with the On level of each intervention condition relative to the Off level of the intervention condition.
Outcome measures
| Measure |
All Reporting Groups
n=300 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of both intervention factors, HbA1c measured at baseline and month 12.
|
Coaching
n=300 Participants
Coaching (Off) or Coaching (On)
|
|---|---|---|
|
Days Per Week Meeting Mealtime Goal During Intervention Period, Main Effects of Each Intervention Component
|
0.443 Days per week
Interval 0.242 to 0.643
|
0.519 Days per week
Interval 0.319 to 0.721
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: ITT population, all randomized participants
Estimated mean change from Baseline to12 months were obtained from a a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the change in HbA1c at 12 months resulting from the impact of the On level of each intervention condition relative to the Off level of the intervention condition as mediated by the mean days per week the glucose checking goal was met.
Outcome measures
| Measure |
All Reporting Groups
n=300 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of both intervention factors, HbA1c measured at baseline and month 12.
|
Coaching
n=300 Participants
Coaching (Off) or Coaching (On)
|
|---|---|---|
|
Change in Percent Glycated Hemoglobin Due to Each Intervention Mediated by Days Met Glucose Checking Goal
|
-0.015 Percent
Interval -0.064 to 0.008
|
-0.007 Percent
Interval -0.052 to 0.005
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: ITT population, all randomized participants
Estimated mean change from Baseline to12 months were obtained from a a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the change in HbA1c at 12 months resulting from the impact of the On level of each intervention condition relative to the Off level of the intervention condition as mediated by the mean days per week the mealtime goal was met.
Outcome measures
| Measure |
All Reporting Groups
n=300 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of both intervention factors, HbA1c measured at baseline and month 12.
|
Coaching
n=300 Participants
Coaching (Off) or Coaching (On)
|
|---|---|---|
|
Change in Percent Glycated Hemoglobin Due to Each Intervention Mediated by Days Met Mealtime Goal
|
-0.053 Percent
Interval -0.11 to -0.019
|
-0.062 Percent
Interval -0.123 to -0.024
|
Adverse Events
Sweetgoals App
Sweetgoals App, Incentives
Sweetgoals App, Coaching
Sweetgoals App, Incentives, Coaching
Serious adverse events
| Measure |
Sweetgoals App
n=75 participants at risk
Sweetgoals app
|
Sweetgoals App, Incentives
n=75 participants at risk
Sweetgoals app, incentives
|
Sweetgoals App, Coaching
n=75 participants at risk
Sweetgoals app, coaching
|
Sweetgoals App, Incentives, Coaching
n=75 participants at risk
Sweetgoals app, incentives, coaching
|
|---|---|---|---|---|
|
Endocrine disorders
Hospitalization related to type 1 diabetes
|
4.0%
3/75 • From enrollment to 12 month followup
Questionnaires sent to all randomized participants. Serious adverse events all reflect hospitalization for either high or low blood glucose.
|
2.7%
2/75 • From enrollment to 12 month followup
Questionnaires sent to all randomized participants. Serious adverse events all reflect hospitalization for either high or low blood glucose.
|
1.3%
1/75 • From enrollment to 12 month followup
Questionnaires sent to all randomized participants. Serious adverse events all reflect hospitalization for either high or low blood glucose.
|
2.7%
2/75 • From enrollment to 12 month followup
Questionnaires sent to all randomized participants. Serious adverse events all reflect hospitalization for either high or low blood glucose.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place