Trial Outcomes & Findings for A Pilot Test of t:Slim X2 With Control-IQ Technology (NCT NCT03368937)
NCT ID: NCT03368937
Last Updated: 2022-05-25
Results Overview
Technology Acceptance Questionnaire Score Scores are on a Likert Scale of 1-Not at All to 5-Extremely for Ease of Use, Usability and Trust in System Scores.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
36-48 hours
Results posted on
2022-05-25
Participant Flow
Participant milestones
| Measure |
Tandem t:Slim X2 With Control-IQ Technology
Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
Tandem t:slim X2 with Control-IQ Technology: Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Test of t:Slim X2 With Control-IQ Technology
Baseline characteristics by cohort
| Measure |
Tandem t:Slim X2 With Control-IQ Technology
n=5 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
Tandem t:slim X2 with Control-IQ Technology: Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
|
|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36-48 hoursTechnology Acceptance Questionnaire Score Scores are on a Likert Scale of 1-Not at All to 5-Extremely for Ease of Use, Usability and Trust in System Scores.
Outcome measures
| Measure |
Tandem t:Slim X2 With Control-IQ Technology
n=5 Participants
Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
Tandem t:slim X2 with Control-IQ Technology: Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
|
|---|---|
|
System Suitability
Ease of Use
|
5 score on a scale
Interval 5.0 to 5.0
|
|
System Suitability
Usefulness
|
4.8 score on a scale
Interval 4.0 to 5.0
|
|
System Suitability
Trust in System
|
5 score on a scale
Interval 5.0 to 5.0
|
Adverse Events
Tandem t:Slim X2 With Control-IQ Technology
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place