Trial Outcomes & Findings for Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes (NCT NCT06098729)

NCT ID: NCT06098729

Last Updated: 2025-09-17

Results Overview

Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2025-09-17

Participant Flow

Participant milestones

Measure	Digital Exercise Exercise intervention
Overall Study STARTED	24
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Digital Exercise Exercise intervention
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes

Baseline characteristics by cohort

Measure	Digital Exercise n=24 Participants Digital exercise intervention
Age, Continuous	48 years STANDARD_DEVIATION 11 • n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	22 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	24 Participants n=93 Participants

PRIMARY outcome

Timeframe: 4 weeks

Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.

Outcome measures

Measure	Digital Exercise n=24 Participants Digital exercise intervention
Feasibility of Usage	168 minutes/week Standard Deviation 14

PRIMARY outcome

Timeframe: 4 weeks

Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)

Outcome measures

Measure	Digital Exercise n=24 Participants Digital exercise intervention
Acceptability	4.0 score on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: 4 weeks

Accuracy to predict lapses in exercise behavior ahead of time. 50% accuracy is the lowest possible value (ie, equivalent to random guessing), 80% accuracy is the goal of the study, and 100% accuracy would be the highest possible accuracy.

This is the single outcome of a regression analysis across the entire sample. Being a single outcome, there is no measure of dispersion.

Outcome measures

Measure	Digital Exercise n=24 Participants Digital exercise intervention
Accuracy	70 percentage of lapses

SECONDARY outcome

Timeframe: 6 weeks

Scale name: Cravings for Rest and Volitional Energy Expenditure (CRAVE) Construct: Transient state motivation for physical activity Scale ranges: 0 (not at all) to 100 (more than ever). Higher values represent a better outcome.

Outcome measures

Measure	Digital Exercise n=24 Participants Digital exercise intervention
Motivation States for Physical Activity	60.1 units on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: 6 weeks

Minutes of moderate to vigorous physical activity registered by hip accelerometer. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.

Outcome measures

Measure	Digital Exercise n=24 Participants Digital exercise intervention
Moderate to Vigorous Physical Activity	168 minutes/week Standard Deviation 14

SECONDARY outcome

Timeframe: 6 weeks

Qualitatively-identified determinants and sequalae of motivation states for physical activity

Outcome measures

Measure	Digital Exercise n=24 Participants Digital exercise intervention
Interview Themes	4 themes

Adverse Events

Digital Exercise

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Digital Exercise n=24 participants at risk Digital exercise intervention
Metabolism and nutrition disorders Level 1 Hypoglycemia	12.5% 3/24 • Number of events 7 • from consenting until end of follow-up, up to 9 weeks
Musculoskeletal and connective tissue disorders Muscle, joint, ligament, or tendon injury	29.2% 7/24 • from consenting until end of follow-up, up to 9 weeks
Infections and infestations COVID	8.3% 2/24 • Number of events 2 • from consenting until end of follow-up, up to 9 weeks
Skin and subcutaneous tissue disorders Skin irritation from wearable device	8.3% 2/24 • Number of events 2 • from consenting until end of follow-up, up to 9 weeks

Additional Information

Garrett Ash

Yale University

Phone: 2034443079

Email: garrett.ash@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place