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Trial registered on ANZCTR


Registration number
ACTRN12614001163695
Ethics application status
Approved
Date submitted
31/10/2014
Date registered
6/11/2014
Date last updated
7/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a novel glucose sensor in type 1 diabetes
Scientific title
A comparison of the performance of an orthogonally redundant glucose sensor to an electrochemical glucose sensor with simple redundancy in type 1 diabetes
Secondary ID [1] 285568 0
None
Universal Trial Number (UTN)
U1111-1163-5283
Trial acronym
ORS comparison study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 293399 0
Condition category
Condition code
Metabolic and Endocrine 293678 293678 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluates the performance of a novel glucose sensor incorporating simple and orthogonal redundancy in people with type 1 diabetes. Currently available glucose sensors measure interstitial fluid glucose levels via electrochemical sensing. Sensor redundancy involves multiple sensing elements incorporated into a single sensor, thereby providing backup in case one element fails. Simple redundancy involves multiple sensing elements employing the same technology, while orthogonal redundancy involves multiple elements employing different technologies which have distinct failure modes.

Each participant will concurrently wear two glucose sensors for one week: 1) the investigational orthogonally redundant sensor (ORS) incorporating optical plus redundant electrochemical glucose sensing, and 2) an electrochemical comparator sensor (ECS) with simple redundancy.

Each sensor will be inserted subcutaneously into the abdomen using a dedicated sensor inserter in the clinical trials centre (CTC), a procedure which takes less than 5 minutes. Each sensor will be attached to a recorder which captures sensor-related information, and this data will be uploaded at the conclusion of the study. Glucose data from the study devices will not be available to the participants and will not impact upon decisions relating to their care.

Immediately following sensor insertion venous samples will be collected for reference blood glucose measurement at standardised 15-30 minute intervals for 3 hours. After 72 +/- 4 hours of sensor wear, participants will return to the CTC and consume a standardised meal. Venous samples will be collected for reference blood glucose measurement at 15 minute intervals from 1 hour prior to the test meal until 3 hours post-meal.

Between visits to the CTC, participants will be instructed to undertake finger prick capillary blood glucose measurements at least 6-8 times per day (pre-meals and 2 hours post-meals) which will be recorded by the glucose meter. Following 168 +/- 4 hours of sensor wear, both the ORS and ECS will be removed in the CTC.
Intervention code [1] 290519 0
Treatment: Devices
Comparator / control treatment
The comparator is an electrochemical glucose sensor with simple redundancy, and reference glucose measurements will be venous and capillary blood glucose levels.
Control group
Active

Outcomes
Primary outcome [1] 293495 0
Performance of the ORS versus ECS (assessed via accuracy and reliability of sensor data), with blood glucose levels as the reference.
Timepoint [1] 293495 0
0 to 168 hours
Secondary outcome [1] 311172 0
ORS versus ECS insertion site appearance (skin assessed as normal or abnormal; any skin abnormalities described and photographed).
Timepoint [1] 311172 0
168 hours post sensor insertion
Secondary outcome [2] 311173 0
ORS versus ECS device comfort and irritability (assessed via non-structured interview).
Timepoint [2] 311173 0
168 hours post sensor insertion

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, 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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] 3104 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 8858 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 290172 0
Charities/Societies/Foundations
Name [1] 290172 0
Juvenile Diabetes Research Foundation
Address [1] 290172 0
26 Broadway
New York NY 10004
Country [1] 290172 0
United States of America
Funding source category [2] 290173 0
Commercial sector/Industry
Name [2] 290173 0
Medtronic Diabetes
Address [2] 290173 0
18000 Devonshire Street
Northridge CA 91325
Country [2] 290173 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] 288883 0
University
Name [1] 288883 0
University of Melbourne
Address [1] 288883 0
29 Regent Street
Fitzroy VIC 3065
Country [1] 288883 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291881 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 291881 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 291881 0
Australia
Date submitted for ethics approval [1] 291881 0
Approval date [1] 291881 0
24/09/2014
Ethics approval number [1] 291881 0
HREC-D 093/14

Summary
Brief summary
Glucose sensor technology has been evolving with an ultimate goal of achieving a level of accuracy required to replace finger prick glucose testing, together with a level of reliability for use in an artificial pancreas. While there have been recent advances in glucose sensing technology, further improvements relating to sensor accuracy and reliability are required.

A glucose sensor based on a novel technology platform has been developed. Studies in animals and humans during development of this sensor have shown positive results, and this will be the first study in humans to formally compare the novel glucose sensor to a glucose sensor based on the traditional sensing platform.
Trial website
Trial related presentations / publications
Feasibility of an Orthogonal Redundant Sensor incorporating Optical plus Redundant Electrochemical Glucose Sensing. Journal of Diabetes Science and Technology 2016. http://www.ncbi.nlm.nih.gov/pubmed/26846821
Public notes

Contacts
Principal investigator
Name 52398 0
A/Prof David O'Neal
Address 52398 0
Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 52398 0
Australia
Phone 52398 0
+61 3 9231 2211
Fax 52398 0
Email 52398 0
dno@unimelb.edu.au
Contact person for public queries
Name 52399 0
Dr Sybil McAuley
Address 52399 0
Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 52399 0
Australia
Phone 52399 0
+61 3 9231 2211
Fax 52399 0
Email 52399 0
sybil.mcauley@svha.org.au
Contact person for scientific queries
Name 52400 0
Dr Sybil McAuley
Address 52400 0
Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 52400 0
Australia
Phone 52400 0
+61 3 9231 2211
Fax 52400 0
Email 52400 0
sybil.mcauley@svha.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