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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01991548




Registration number
NCT01991548
Ethics application status
Date submitted
18/11/2013
Date registered
25/11/2013
Date last updated
15/05/2017

Titles & IDs
Public title
User Evaluation of the MiniMed 640G Insulin Pump
Scientific title
A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
Secondary ID [1] 0 0
CEP284
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 - MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

Other: Diabetic participants with study devices -


Treatment: Devices: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
Criteria for Inclusion: A subject is eligible for the user evaluation study if all of the
following criteria are met:

1. Subject is 7 years or older at time of screening

2. Subject is current insulin pump user for at least 3 months

3. Subject has the following CGM 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

4. Subject/legal representative has signed a Patient Informed Consent and is willing to
comply with the study procedures;

5. Subject is willing to complete study questionnaires throughout the study

6. Must have the following clinical diagnosis:

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

Criteria for
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: A subject is excluded from the user evaluation if any of the
following criteria are met:

1. Female subject has a positive urine pregnancy screening test.

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becomes pregnant during participation, she will be withdrawn

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

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

5. Subject is unable to tolerate tape adhesive in the area of sensor placement

6. Subject has any unresolved adverse skin condition in the area of sensor placement
(e.g. psoriasis, rash, Staphylococcus infection)

7. Subject has travel plans which would make it difficult for the subject to attend
on-site study visits as scheduled

8. 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 (CEP267 User Evaluation is not included in this
exclusion criteria).

Study design
Purpose of the study
Treatment
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
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
52
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
3050 - Fitzroy
Recruitment postcode(s) [2] 0 0
3050 - Patkville
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 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 four center international study will include two United Kingdom National Health Service
centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate
subject acceptance of 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 four 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/ct2/show/NCT01991548
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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