Trial Outcomes & Findings for User Evaluation of the MiniMed 620G and 640G Insulin Pumps (NCT NCT01726621)

Last Updated: 2016-04-18

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 overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

Four weeks of pump wear

Results posted on

2016-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Insulin Dependent Diabetics Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
Overall Study STARTED	55
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

User Evaluation of the MiniMed 620G and 640G Insulin Pumps

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Depedent Diabetics n=55 Participants Subject is current insulin pump user and has CGM experience as determined by the investigator.
Age, Categorical <=18 years	19 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31.3 years STANDARD_DEVIATION 16.91 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Four weeks of pump wear

Outcome measures

Outcome measures
Measure	Insulin Depedent Diabetics n=55 Participants Subject is current insulin pump user and has CGM experience as determined by the investigator.
User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter	5.88 units on a scale Standard Deviation 1.32

Adverse Events

Insulin Dependent Diabetics

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Insulin Dependent Diabetics n=55 participants at risk Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter Medtronic MiniMed 620G or 640G Insulin Pump: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.
Skin and subcutaneous tissue disorders Bleeding cannula site	1.8% 1/55 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough with sputum	1.8% 1/55 • Number of events 1
Gastrointestinal disorders Diarrhoea	1.8% 1/55 • Number of events 1
Endocrine disorders Hyperglycaemia	1.8% 1/55 • Number of events 1
Skin and subcutaneous tissue disorders Insulin infusion set insertion site - bruising	1.8% 1/55 • Number of events 1
Endocrine disorders Ketonemia	1.8% 1/55 • Number of events 1
Immune system disorders Pyrexia	1.8% 1/55 • Number of events 1
Skin and subcutaneous tissue disorders Rash	1.8% 1/55 • Number of events 1
Endocrine disorders Severe hypoglycemia	1.8% 1/55 • Number of events 1
Skin and subcutaneous tissue disorders Skin irritation	1.8% 1/55 • Number of events 1
Skin and subcutaneous tissue disorders Skin irritation from Enlite sensor tape	1.8% 1/55 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sore throat	1.8% 1/55 • Number of events 1
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	5.5% 3/55 • Number of events 3
Renal and urinary disorders Urinary infection	1.8% 1/55 • Number of events 1

Additional Information

Clinical Research Manager

Medtronic MiniMed, Inc

Phone: 8185765171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER