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Trial registered on ANZCTR


Registration number
ACTRN12613000705785
Ethics application status
Approved
Date submitted
25/06/2013
Date registered
28/06/2013
Date last updated
7/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study of a novel glucose sensor in type 1 diabetes
Scientific title
A feasibility study examining a novel orthogonally redundant continuous glucose sensor in type 1 diabetes
Secondary ID [1] 282720 0
Nil known
Universal Trial Number (UTN)
U1111-1144-9406
Trial acronym
ORS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 289440 0
Condition category
Condition code
Metabolic and Endocrine 289767 289767 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A feasibility study to assess the accuracy and reliability of a novel continuous glucose monitoring (CGM) system in vivo in people with type 1 diabetes. For the duration of the study participants will concurrently wear two glucose sensors: 1) the investigational device - an electrochemical and optical fluorescence-based orthogonally redundant sensor (ORS), and 2) a non-redundant electrochemical sensor based on current CGM platforms.

Each sensor will be inserted subcutaneously into the abdomen using a dedicated sensor inserter, a procedure which takes under 5 minutes.

Immediately after sensor insertion, venous samples will be collected at 30 minute intervals for 4 hours for plasma glucose and glucose meter levels. After 48 or 72 hours +/- 4 hours of sensor wear participants will return to the clinical trials centre (CTC) and consume a standardised meal. Venous samples will be collected at 15 minutes intervals from 1 hour prior to the test meal until 3 hours post-meal for plasma glucose and glucose meter levels.

Between visits to the CTC, finger prick glucose measurements will be performed a minimum of 6-8 times per day (spread throughout the day pre-meals and two hours post-meals) for the duration of the study.

Glucose data from the study devices will not be available to the participants and will not impact on decisions involving their care. All participants will wear both sensors (investigational ORS and electrochemical) for up to 168 hours, with the first participant wearing the devices for 48 hours +/- 4 hours, followed by stepped increases in duration of wear up to 168 hours +/- 4 hours based on data analysis of prior data from participants.
Intervention code [1] 287381 0
Treatment: Devices
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289852 0
Accuracy of investigational ORS glucose data in comparison to plasma glucose and glucose meter levels as references
Timepoint [1] 289852 0
Day 1, Day 3 or 4, +/- Day 8
Primary outcome [2] 289853 0
Descriptive comparison of sensor accuracy using sensor glucose data provided by investigational ORS and electrochemical sensor in comparison to plasma glucose and glucose meter levels as references
Timepoint [2] 289853 0
0-168 hours
Secondary outcome [1] 303385 0
Duration of function of investigational ORS versus electrochemical sensor determined by provision of glucose measurements from sensor to sensor recorder
Timepoint [1] 303385 0
Up to 168 hours
Secondary outcome [2] 303386 0
Sensor insertion site appearance of investigational ORS versus electrochemical sensor (visual assessment)
Timepoint [2] 303386 0
Day 3 or 4, +/- Day 8

Eligibility
Key inclusion criteria
Clinical diagnosis of type 1 diabetes, insulin treatment for diabetes, experience with glucose sensor use.
Minimum age
21 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or planned pregnancy within study period, inability to tolerate tape adhesive in the area of device placement, adverse skin condition in the area of device placement.

Study design
Purpose of the study
Treatment
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
Up to 30 participants will be studied. The number of participants studied will depend on the results of interim data analyses
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a feasibility study involving the first extensive in vivo testing of the ORS in a real-world scenario. Extensive in-vitro, pre-clinical and limited in-vivo data indicate that more detailed in-vivo testing of this novel sensor technology is warranted. Descriptive analyses will be used to summarise the performance and safety results.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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)
VIC
Recruitment hospital [1] 1153 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 7000 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 287493 0
Charities/Societies/Foundations
Name [1] 287493 0
Juvenile Diabetes Research Foundation
Address [1] 287493 0
26 Broadway
New York, NY 10004
Country [1] 287493 0
United States of America
Funding source category [2] 287494 0
Commercial sector/Industry
Name [2] 287494 0
Medtronic Diabetes
Address [2] 287494 0
18000 Devonshire Street
Northridge, CA 91325
Country [2] 287494 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 286232 0
University
Name [1] 286232 0
University of Melbourne
Address [1] 286232 0
29 Regent Street
Fitzroy VIC 3065
Country [1] 286232 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289466 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 289466 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 289466 0
Australia
Date submitted for ethics approval [1] 289466 0
23/04/2013
Approval date [1] 289466 0
27/06/2013
Ethics approval number [1] 289466 0
#059/13

Summary
Brief summary
Glucose sensor technology for continuous glucose monitoring (CGM) in diabetes has been evolving with an ultimate goal of achieving a level of reliability and accuracy required to replace finger prick glucose measurement. Although CGM technology advances have increased accuracy, reliability and ease of use, further improvements are required.

A CGM system based on a novel technology platform has been developed. Early laboratory testing, animal studies and limited testing in humans indicates that further human studies are warranted. This feasibility study of the novel glucose sensor is the first extensive testing of this sensor in humans.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40978 0
A/Prof David O'Neal
Address 40978 0
Department of Endocrinology and Diabetes,
St Vincent's Hospital Melbourne,
35 Victoria Parade Fitzroy VIC 3065
Country 40978 0
Australia
Phone 40978 0
+61 3 9288 2211
Fax 40978 0
Email 40978 0
dno@unimelb.edu.au
Contact person for public queries
Name 40979 0
Dr Sybil McAuley
Address 40979 0
Department of Endocrinology and Diabetes,
St Vincent's Hospital Melbourne,
35 Victoria Parade Fitzroy VIC 3065
Country 40979 0
Australia
Phone 40979 0
+61 3 9288 2211
Fax 40979 0
Email 40979 0
sybil.mcauley@svhm.org.au
Contact person for scientific queries
Name 40980 0
Dr Sybil McAuley
Address 40980 0
Department of Endocrinology and Diabetes,
St Vincent's Hospital Melbourne,
35 Victoria Parade Fitzroy VIC 3065
Country 40980 0
Australia
Phone 40980 0
+61 3 9288 2211
Fax 40980 0
Email 40980 0
sybil.mcauley@svhm.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary