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Trial registered on ANZCTR


Registration number
ACTRN12612000144819
Ethics application status
Not yet submitted
Date submitted
18/01/2012
Date registered
1/02/2012
Date last updated
1/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the Accu-chek Mobile blood glucose monitoring system of testing frequency in type one diabetes.
Scientific title
A randomized parallell group cross-over study of the effect of the use of two blood glucose monitoring systems (Accu-Chek Mobile and Optium Exeed) in patients with type one diabetes on the frequency of blood glucose monotoring and patient satisfaction.
Secondary ID [1] 279749 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 285611 0
Condition category
Condition code
Metabolic and Endocrine 285803 285803 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Accu-chek Mobile (TM) system
The Mobile (TM) incorporates a number of features which eliminate the need to handle test strips or single lancets before and after use, giving the user more freedom and flexibility when monitoring blood glucose, as well as allowing more discrete monitoring. The Mobile(TM) also allows the user to set up to 10 reminder times – at each set time a beep sounds and the reminder time is displayed.
Participants will be randomized to use the Mobile(TM) or the comparator system (see below) 4 times daily for 3 months and then will cross over (without washout) to the alternative system for a futher 3 months. Participants will then be asked to use their preferred system exclusively for a futher 3 months (total duration 9 months).
Intervention code [1] 284063 0
Behaviour
Intervention code [2] 284064 0
Other interventions
Comparator / control treatment
Optium Xceed (tm)
This is the most popular existing sytem in the market and is a conventional meter with separate test strips (loaded into the machine separately for each test) and a separate lancet device.
Participants will be randomized to use the Xceed(TM) or the comparator system (see above) 4 times daily for 3 months and then will crossover (without washout) to the alternative system for a futher 3 months. Participants will then be asked to use their preferred system exclusively for a futher 3 months (total duration 9 months).
Control group
Active

Outcomes
Primary outcome [1] 286316 0
Average blood glucose estimations/week
This will be assessed by downloading the machine memory and counting the number of tests performed in the 3 month period.
Timepoint [1] 286316 0
0,3,6,9 months
Secondary outcome [1] 295596 0
Psychosocial measures
The Diabetes Treatment Satisfaction Questionnaire (DTSQ) Confidence in Diabetes Scale (CIDS)
Problem Areas in Diabetes Management (PAID) Scale
The modified* Blood Glucose Monitoring Questionnaire (BGM-Q) [* questions 4,15 & 16 removed].
Timepoint [1] 295596 0
0,3,6,9 months

Eligibility
Key inclusion criteria
1. Type 1 diabetes diagnosed for greater than or equal to one year
2. Known to the study site (ie. attended for clinical care greater than or equal to 2 visits in the last 2 years)
3. Glycosylated haemoglobin (HbA1c) greater than or equal to 7.5 %
4. Aged 18-45 years
5. Their health care professional recommends that they monitor greater than or equal to 4 times a day
5. They are performing some monitoring but less than 21 blood glucose estimations per week
6. They are able to understand, read and write English without assistance
7. They are willing to attend for all of the scheduled study visits
8. They are prepared to use the two blood glucose monitoring systems being used in the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 2 diabetes
2. Use of oral or inhaled steroids
3 They are pregnant or planning a pregnancy
4. They have an infection
5. medical condition, such as cancer, severe depression or other psychological conditions that, in the opinion of the investigators, makes the person unsuitable for inclusion in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randmized at study entry to one or other of the monitoring devices. The study is not blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each centre will recruit in order and the treatment allocation will be determined by a randomization table generated by computer at http://www.randomization.com
50 subjects randomized
To reproduce this plan, use the seed 8356
Randomization plan created on Thursday, 22 December 2011 3:34:08 PM
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
After three months patients will cross-over to the alternative device and at 6 months they will be allowed to use their preferred meter for a further 3 months.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4857 0
3128

Funding & Sponsors
Funding source category [1] 284534 0
Commercial sector/Industry
Name [1] 284534 0
Roche Diagnostics Australia Pty Ltd
Country [1] 284534 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Roche Diagnostics Australia Pty Ltd
Address
31 Victoria Avenue
Castle Hill. NSW, 2154
Australia
Country
Australia
Secondary sponsor category [1] 283463 0
None
Name [1] 283463 0
Address [1] 283463 0
Country [1] 283463 0
Other collaborator category [1] 260460 0
Hospital
Name [1] 260460 0
Royal Prince Alfred Hospital
Address [1] 260460 0
Missenden Road
Camperdown NSW 2050
Country [1] 260460 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286520 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 286520 0
Level 2, 5 Arnold Street
Box Hill
Victoria
3128
Ethics committee country [1] 286520 0
Australia
Date submitted for ethics approval [1] 286520 0
14/12/2011
Approval date [1] 286520 0
Ethics approval number [1] 286520 0
E39-1112

Summary
Brief summary
This project aims to test whether a new blood glucose monitoring system increases the number of tests that patients with type 1 diabetes do as compared with an existing blood glucose monitoring system.
The project also aims to test whether the new blood glucose testing system improves diabetic control and improves how you feel about your diabetes.
The project also aims to test whether the new blood glucose testing system is preferred by users over the existing system
Many studies have demonstrated that regular self monitoring of blood glucose improved overall control in type 1 diabetes and that better control results in better long-term outcomes and fewer complications.
There are many reasons why people with type 1 diabetes do not monitor optimally. These include forgetfulness, difficulties with handling and disposing of test strips, lifestyle alignment (embarrassment of monitoring in public and lack of time and difficulty monitoring away from home), as well as inability to make decisions based on results.
The new blood glucose testing system addresses some of these issues and previous surveys have shown that compliance with a testing regime is improved. There has, however, not been a formal study of the system to date and this study hopes to fill that gap in medical knowledge.
Fifty people with type 1 diabetes will be recruited from Eastern Health and Royal Prince Alfred diabetes clinics to participate in the study.
Subjects will be randomized to receive either the existing or the new system to begin with and to use that system for 3 months. After that period subjects will swap to the alternate system for a further 3 months. At the end of 6 months subject will be able to chose which system they prefer to use for the remaining 3 months of the study which therefore has a total duration of 9 months.
Subjects will be required to attend every 3 months during the study (total of 4 visits) at which time the content of the meters memory will be down loaded for analysis. Subject will also be asked to complete questionnaires relating to their mood, level of distress, attitude and satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33648 0
Address 33648 0
Country 33648 0
Phone 33648 0
Fax 33648 0
Email 33648 0
Contact person for public queries
Name 16895 0
Christopher Gilfillan
Address 16895 0
Box Hill Hospital
Level 2 , 5 Arnold street
Box Hill
Victoria 3128
Country 16895 0
Australia
Phone 16895 0
613 9895 4031
Fax 16895 0
613 9899 9137
Email 16895 0
[email protected]
Contact person for scientific queries
Name 7823 0
Christopher Gilfillan
Address 7823 0
Box Hill Hospital
Level 2 , 5 Arnold street
Box Hill
Victoria 3128
Country 7823 0
Australia
Phone 7823 0
613 9895 4031
Fax 7823 0
613 9899 9137
Email 7823 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23211Clinical study report   

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 361970-(Uploaded-22-07-2019-11-30-02)-Basic results summary.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIImproving Self-Monitoring of Blood Glucose among Adults with Type 1 Diabetes: Results of the Mobile™ Study2014https://doi.org/10.1007/s13300-014-0092-9
N.B. These documents automatically identified may not have been verified by the study sponsor.