Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Sex
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
NA
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
NA
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
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
55
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01726621