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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 1 diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

Behaviour

Intervention code [2]

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]

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]

0,3,6,9 months

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3128

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Roche Diagnostics Australia Pty Ltd

Address [1]

31 Victoria Avenue
Castle Hill. NSW, 2154
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Royal Prince Alfred Hospital

Address [1]

Missenden Road
Camperdown NSW 2050

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Eastern Health Research and Ethics Committee

Ethics committee address [1]

Level 2, 5 Arnold Street 
Box Hill
Victoria
3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/12/2011

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Christopher Gilfillan

Address

Box Hill Hospital
Level 2 , 5 Arnold street
Box Hill
Victoria 3128

Country

Australia

Phone

613 9895 4031

Fax

613 9899 9137

[email protected]

Contact person for scientific queries

Name

Christopher Gilfillan

Address

Box Hill Hospital
Level 2 , 5 Arnold street
Box Hill
Victoria 3128

Country

Australia

Phone

613 9895 4031

Fax

613 9899 9137

[email protected]

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

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			361970-(Uploaded-22-07-2019-11-30-02)-Basic results summary.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Improving Self-Monitoring of Blood Glucose among Adults with Type 1 Diabetes: Results of the Mobile™ Study	2014	https://doi.org/10.1007/s13300-014-0092-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically