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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01726621




Registration number
NCT01726621
Ethics application status
Date submitted
8/11/2012
Date registered
15/11/2012
Date last updated
18/04/2016

Titles & IDs
Public title
User Evaluation of the MiniMed 620G and 640G Insulin Pumps
Scientific title
A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter
Secondary ID [1] 0 0
CEP267
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic MiniMed 620G or 640G Insulin Pump

Other: Insulin dependent diabetics - Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter - 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.
Timepoint [1] 0 0
Four weeks of pump wear

Eligibility
Key inclusion criteria
- Subject is 7 years or older at time of screening

- Subject is current insulin pump user for at least 3 months

- Subject has the following Continuous Glucose Monitoring experience as determined by
the Investigator:

- Has experience and is able to insert/change sensor by herself/himself and

- Has experience and can recharge the transmitter and

- Has experience and can read sensor data in real-time on her/his pump screen

- Subject has signed a Patient Informed Consent form and is willing to comply with the
study procedures;

- Subject is willing to complete study questionnaires throughout the study

- Must have one of the following clinical diagnosis:

- Type 1 diabetes, for a minimum of 6 months prior to enrollment

- Insulin requiring type 2 diabetes, for a minimum of 6 months prior to enrollment
Minimum age
7 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Female subject has a positive urine pregnancy screening test.

- Female subject who plans to become pregnant during the course of study. If a woman
becomes pregnant during participation, she will be withdrawn

- Subject has any condition that, in the opinion of the Investigator or qualified
Investigational Center staff, may preclude him/her from participating in the study and
completing study related procedures.

- Subject has impaired vision or hearing problems that could compromise the handling of
the device as determined by Investigator or qualified Investigational Center staff

- Subject is actively participating in an investigational study (drug or device) wherein
he/she has received treatment from an investigational study drug or investigational
study device in the last 2 weeks.

Study design
Purpose of the study
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent Hospital and The University of Melbourne - Fitzroy
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Patkville
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3050 - Patkville
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Herlev
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona
Country [3] 0 0
United Kingdom
State/province [3] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Diabetes
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This six center international study will include two United Kingdom National Health Service
centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The
objective of the study is to evaluate subject acceptance of the a new insulin pump and
transmitter together with the accompanying training materials. Descriptive data from
participant questionnaires and device uploads will be evaluated.

Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of
age upwards, who currently use an insulin pump in the management of their type 1 or type 2
diabetes, will be invited to participate. Each subject will be trained on the study device
and then use it for approximately six weeks. During this time there will be three in-clinic
visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of
this period, they will revert back to their original insulin pump and complete a
questionnaire on the study pump training materials, features and usability.
Trial website
https://clinicaltrials.gov/show/NCT01726621
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pratik Choudhary, MBBS, MRCP
Address 0 0
King's College London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications