Trial Outcomes & Findings for Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus (NCT NCT06018844)

NCT ID: NCT06018844

Last Updated: 2025-08-19

Results Overview

percent of daily text messages exchanged between youth and the NUDGE bot

Recruitment status

TERMINATED

Target enrollment

1 participants

Primary outcome timeframe

Through study completion, an average of 3.5 months

Results posted on

2025-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Primary Arm Main group of patients 13.00 to 21.99 with T1D
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Arm n=1 Participants Main group of patients 13.00 to 21.99 with T1D
Age, Continuous	17 years n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	0 Participants n=93 Participants
Race (NIH/OMB) White	1 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

PRIMARY outcome

Timeframe: Through study completion, an average of 3.5 months

Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.

percent of daily text messages exchanged between youth and the NUDGE bot

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1, 30 and 90

Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.

Participants' MVPA levels

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, 30 and 90

Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.

Percent of days that youth wear the actigraph

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, 30 and 90

Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.

percent of daily PA schedules that participants complete

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, an average of 3.5 months

Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.

Change in participant HbA1c

Outcome measures

Outcome data not reported

Adverse Events

Primary Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Priscilla Connell

Children's Mercy Research Institute

Phone: 8166014543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place