Trial Outcomes & Findings for User Evaluation of the MiniMed 640G Insulin Pump (NCT NCT01991548)

Results Overview

Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

Four weeks of pump wear

Results posted on

2017-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Insulin Dependent Diabetics Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 640G insulin pump and Guardian Link transmitter.
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

User Evaluation of the MiniMed 640G Insulin Pump

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Dependent Diabetics n=40 Participants individuals with insulin dependant diabetes using the 640G insulin pump for insulin infusion and continuous glucose monitoring
Age, Categorical <=18 years	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31.7 years STANDARD_DEVIATION 17.74 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Four weeks of pump wear

Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.

Outcome measures

Outcome measures
Measure	Overall n=50 Participants Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter	6.02 units on a scale Standard Deviation 1.13

Adverse Events

Overall

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Overall n=40 participants at risk Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
General disorders Dermatitis contact	5.0% 2/40 • Number of events 2 • October 24, 2014 through November 12, 2014
Infections and infestations Nasopharyngitis	2.5% 1/40 • Number of events 1 • October 24, 2014 through November 12, 2014
Infections and infestations Urinary tract infection	2.5% 1/40 • Number of events 1 • October 24, 2014 through November 12, 2014

Additional Information

Clinical Research Manager

Medtronic Diabetes

Phone: 818-576-5000

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place