Trial Outcomes & Findings for Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart) (NCT NCT05992350)
NCT ID: NCT05992350
Last Updated: 2025-10-17
Results Overview
Minutes per Day of MVPA
TERMINATED
45 participants
Up to 365 days +- 30 days
2025-10-17
Participant Flow
Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
Participant milestones
| Measure |
Primary Analysis Arm
Youth (8-21 YO) diagnosed with T1D.
|
Parent Arm
Parents of youth (8-18YO) diagnosed with T1D.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
Baseline characteristics by cohort
| Measure |
Primary Analysis Arm
n=24 Participants
Youth (8-21 YO) diagnosed with T1D
|
Parent Arm
n=21 Participants
Parents of youth (8-18 YO) diagnosed with T1D
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
3 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
21 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Sex: Female, Male
Female
|
10 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
10 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Sex: Female, Male
Male
|
14 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
14 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
3 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
17 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
4 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
4 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Race (NIH/OMB)
White
|
19 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
19 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
1 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
—
|
0 Participants
n=24 Participants • Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
|
PRIMARY outcome
Timeframe: Up to 365 days +- 30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Minutes per Day of MVPA
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 90 days +- 30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Rate of hospitalization for diabetic ketoacidosis
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 180 days +- 30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Rate of hospitalization for diabetic ketoacidosis
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 365 +-30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Rate of hospitalization for diabetic ketoacidosis
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Over 90, 180, and 365 +- 30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Time where blood glucose is in an appropriate range (and other glucose measurements)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 90 +- 30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 180 +- 30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 365 +- 30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 365 days +- 30 daysPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Minutes of Sleep per Day
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between 0, 6, and 12 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between 0, 6, and 12 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between 0, 6, and 12 monthsPopulation: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Outcome measures
Outcome data not reported
Adverse Events
Primary Analysis Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Primary Analysis Arm
n=24 participants at risk
Youth (8-21 YO) diagnosed with T1D.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
3/24 • Number of events 3 • 1 year
Only adverse events were monitored for youth as parents only completed Hypoglycemic Fear Scale II for Parents (HFS-P) for the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place