Trial Outcomes & Findings for United Kingdom User Evaluation, MiniMed Paradigm® X54 System (NCT NCT01267175)

NCT ID: NCT01267175

Last Updated: 2023-06-23

Results Overview

Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2023-06-23

Participant Flow

Participant milestones

Measure	X54 Pump All subjects transferred from current pump to X54
Overall Study STARTED	31
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	X54 Pump All subjects transferred from current pump to X54
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

United Kingdom User Evaluation, MiniMed Paradigm® X54 System

Baseline characteristics by cohort

Measure	X54 Pump n=31 Participants All subjects transferred from current pump to X54
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.9 years STANDARD_DEVIATION 10.64 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United Kingdom	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use.

Outcome measures

Measure	X54 Pump n=31 Participants All subjects transferred from current pump to X54
Usability of the X54 Insulin Pump Meets Expectations	5.9 Scores on a scale Standard Deviation 1.56

SECONDARY outcome

Timeframe: 5 weeks

Questionnaire completed at the end of the study, measuring usability of the device training manual. Results scored on a Likert scale of 1 - 7, 1 being the least user friendly and 7 being the most user friendly.

Outcome measures

Measure	X54 Pump n=31 Participants All subjects transferred from current pump to X54
Usability of the Training Material Meets Expectations	6.1 Scores on a scale Standard Deviation 1.16

Adverse Events

X54 Pump

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

Harold Torunsky

Medtronic Diabetes

Phone: (818) 576 5445

Email: harold.torunsky@medtronic.com

Results disclosure agreements

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

Restriction type: GT60