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Trial registered on ANZCTR


Registration number
ACTRN12615000785505
Ethics application status
Approved
Date submitted
1/06/2015
Date registered
29/07/2015
Date last updated
18/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of user acceptance and performance of a mobile real-time continuous glucose monitoring system.
Scientific title
An evaluation of user acceptance and performance of a mobile real-time continuous glucose monitoring system in people with type 1 diabetes.
Secondary ID [1] 286681 0
Nil
Universal Trial Number (UTN)
U1111-1169-9848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes. 295024 0
Condition category
Condition code
Metabolic and Endocrine 295285 295285 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the user acceptance of a real time continuous glucose monitoring (RT-CGM) system in people with T1D. This study also intends to evaluate the performance of the system and the the impact it has on glycaemia.

The RT-CGM system consists of a glucose sensor and transmitter (measuring interstitial fluid glucose level), and a linked study iPod displaying glucose information.

This study involves a single group of 10 participants with T1D using the RT-CGM system. Following baseline clinical assessment, the researcher will provide participants with education about the study devices taking approximately 1 hour. Initial venous blood sampling for HbA1c and 1,5 anhydroglucitol (1,5 AG) will be taken. One hour following sensor insertion, participants will undergo a frequent sampling test (FST) with collection of venous blood to measure plasma glucose at 20 minute intervals for a duration of 3 hours. For the 2 week study period participants will be instructed to undertake reference capillary blood glucose measurements (a minimum of 4 times a day) and to wear the RT-CGM system continuously.

For the study duration, participants will also be instructed to keep a diary documenting activity, diet, capillary blood glucose reading, insulin, and symptomatic hypoglycaemia episodes.

Participants will attend a study visit on Day 8 to have their RT-CGM sensor changed, iPod data downloaded and their glucose data reviewed. On Day 15, participants will attend their final study visit for collection of the study devices and diary. An intravenous cannula will be inserted in the cubital fossa and venous blood for HbA1c and 1,5 AG will be taken. Participants will then be provided a meal and have venous blood collected at 20 minute intervals over the following 3 hours for plasma glucose measurements. A user evaluation questionnaire will also be completed.

Intervention code [1] 291830 0
Treatment: Devices
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295027 0
Participant acceptance regarding comfort and utility of the RT-CGM.
Timepoint [1] 295027 0
Assessed via a questionnaire on Day 15, specifically designed for the study.
Secondary outcome [1] 314617 0
Performance of the RT-CGM measured by proportion of time the glucose sensor reading is displayed and the mean absolute relative difference compared to plasma and study meter glucose.
Timepoint [1] 314617 0
Monitored over the 14 days of the study.
Secondary outcome [2] 314772 0
Change in overall glycaemia as measured by laboratory assays for 1,5 AG.
Timepoint [2] 314772 0
Venous blood samples obtained on Day 1 and Day 15.

Eligibility
Key inclusion criteria
T1D with glucose sensor use experience
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Pregnant or planned pregnancy during the study period
-Life-threatening illness
-Major psychiatric illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to define correlations between the study parameters in phase 1. Phase 1 is an exploratory hypothesis-generating study, therefore statistical power has not been calculated though results will be used to inform larger studies incorporating clinical interventions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2015
Actual
10/08/2015
Date of last participant enrolment
Anticipated
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3783 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 9664 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 291256 0
Commercial sector/Industry
Name [1] 291256 0
Medtronic Diabetes
Country [1] 291256 0
United States of America
Primary sponsor type
Hospital
Name
St Vincents Hospital Melbourne
Address
41 Victoria Parade
Fitzroy 3065 VIC
Country
Australia
Secondary sponsor category [1] 289932 0
None
Name [1] 289932 0
Address [1] 289932 0
Country [1] 289932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292820 0
St Vincents Hospital Melbourne
Ethics committee address [1] 292820 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 292820 0
Australia
Date submitted for ethics approval [1] 292820 0
Approval date [1] 292820 0
07/05/2015
Ethics approval number [1] 292820 0

Summary
Brief summary
Finger-prick capillary glucose levels typically inform insulin administration in T1D. RT-CGM involves using a subcutaneous sensor to measure interstitial fluid glucose levels continuously and provides the person with the glucose level in real-time, as well as the rate and direction of change in the glucose.

There is an increasing body of evidence indicating that RT-CGM in combination with an insulin pump results in an improvement in glycaemia and reduces hypoglycaemia, compared with finger-prick glucose measurement and multiple daily injections with insulin in people with T1DM. However, data is limited regarding the use of RT-CGM in conjunction with multiple daily insulin injections.

The study aims to evaluate the user acceptance of the RT-CGM device in patients with T1D, as well as to evaluate its' impact on glycaemic control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57086 0
A/Prof David O'Neal
Address 57086 0
St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy Victoria 3065
Country 57086 0
Australia
Phone 57086 0
+61 3 92312211
Fax 57086 0
Email 57086 0
[email protected]
Contact person for public queries
Name 57087 0
Sybil McAuley
Address 57087 0
Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 57087 0
Australia
Phone 57087 0
+61 3 92312211
Fax 57087 0
Email 57087 0
[email protected]
Contact person for scientific queries
Name 57088 0
Sybil McAuley
Address 57088 0
Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 57088 0
Australia
Phone 57088 0
+61 3 92312211
Fax 57088 0
Email 57088 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
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