Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000256673
Ethics application status
Approved
Date submitted
5/03/2014
Date registered
11/03/2014
Date last updated
27/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility Study of a Novel Glucose Sensor for Continuous Glucose Monitoring in Type 1 Diabetes.
Scientific title
A Feasibility Study Examining the Accuracy and Reliability of a Novel Redundant Electrochemical Sensor (Harmony Sensor) for Continuous Glucose Monitoring in Type 1 Diabetes.
Secondary ID [1] 284182 0
None
Universal Trial Number (UTN)
U1111-1154-0142
Trial acronym
Harmony
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 291280 0
Condition category
Condition code
Metabolic and Endocrine 291634 291634 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Harmony Sensor represents an advance in electro-chemical sensor design and incorporates a redundant sensor system. Redundancy can be defined as two or more sensing elements utilizing the same or different technologies to measure the same output. The Harmony sensor consists of a unique electro-chemical sensor in a fold-over design, so that there are sensing elements on both planar surfaces.
This feasibility study will assess the accuracy and reliability of the redundant electrochemical sensor (Harmony) for Contiuous Glucose Monitoring (CGM) compared to current non-redundant electrochemical sensors.

All participants will continuously wear two investigational Harmony glucose sensors for the whole duration of the study (168 hours).
Each sensor will be inserted subcutaneously into the abdomen using a dedicated sensor inserter, a procedure which takes under 5 minutes.

Both sensors are attached to a glucose sensor recorder or transmitter which will capture all sensor related information and be uploaded at the conclusion of the study.

The participant will follow the following schedule:

Visit 1 (Day 1): Both sensors will be inserted. Devise training will be provided to the participants. Finger-prick capillary glucose will be performed via study glucose meter at 30 minute intervals for half-an-hour prior to and 3 hours post sensor insertion (first 15 participants), and at 30 minute intervals from half-an-hour to 3 hours post sensor insertion (last 15 participants).

Visit 2 (Day 4): 72 hours post insertion of the sensors, participants will return to clinical trial centre (CTC) to perform a meal test. A standardised test meal containing 65g carbohydrate will be consumed by each participant. Venous blood samples will be collected at 15 minute intervals for half-an-hour prior to and 3 hours post meal ingestion, to be used for glucose measurement by YSI and study glucose meter.

Visit 3 (Day 8): 168 hours post insertion of the sensors, participants will return CTC to perform a final meal test. A standardised test meal containing 65g carbohydrate will be consumed by each participant. Venous blood samples will be collected at 15 minute intervals for half-an-hour prior to and 3 hours post meal ingestion, to be used for glucose measurement by YSI and study glucose meter.

Between the visits, participants will be instructed to perform finger-prick glucose levels a minimum of 8 times a day (pre-meals and 2 hours post meals) which wil be recorded on the study glucose meter history.

Data from study devices will not impact upon decisions involving care of the participants as sensor generated glucose data will not be available to the participants.
Intervention code [1] 288906 0
Treatment: Devices
Comparator / control treatment
The Comparator will be meter YSI glucose values and glucose meter values.
Control group
Active

Outcomes
Primary outcome [1] 291609 0
Accuracy of sensor glucose data provided by the Investigational (Harmony) sensor with meter glucose and YSI glucose values as references.
Timepoint [1] 291609 0
Day 1, Day 4, Day 8 of the study
Primary outcome [2] 291610 0
Descriptive comparison of sensor accuracy using sensor glucose data provided by investigational Harmony sensors in comparison to YSI glucose values and glucose meter values as references.
Timepoint [2] 291610 0
0 - 168 hours
Secondary outcome [1] 307157 0
Device survival of the Harmony sensor determined by provision of glucose measurements from sensor to senor recorder.
Timepoint [1] 307157 0
0 - 168 hours
Secondary outcome [2] 307158 0
Sensor insertion site appearance of the Harmony sensors determined by visual assessment.
Timepoint [2] 307158 0
Day 8 of the study (after removal of sensors)

Eligibility
Key inclusion criteria
1. Participant is 21-70 years of age at time of screening.
2. A clinical diagnosis of type 1 diabetes, as determined by the Investigator.
3. Participant is using insulin to treat his/her diabetes.
4. Currently using a sensor or has experience with sensor use.
5. Preference will be given to subjects who have a history of hypoglycaemia
6. Participant is willing to comply with all requirements associated with the protocol.
Minimum age
21 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant has a positive pregnancy screening test
2. Participant is female and plans to become pregnant during the course of the study.
3. Participant is unable to tolerate tape adhesive in the area of sensor placement.
4. Participant has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2014
Actual
17/03/2014
Date of last participant enrolment
Anticipated
Actual
8/03/2015
Date of last data collection
Anticipated
Actual
15/03/2015
Sample size
Target
30
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2172 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 2921 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 7853 0
3065 - Fitzroy
Recruitment postcode(s) [2] 8647 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 288834 0
Commercial sector/Industry
Name [1] 288834 0
Medtronic
Country [1] 288834 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] 287528 0
University
Name [1] 287528 0
University of Melbourne
Address [1] 287528 0
29 Regent Street
Fitzroy VIC 3065
Country [1] 287528 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290674 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 290674 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 290674 0
Australia
Date submitted for ethics approval [1] 290674 0
27/01/2014
Approval date [1] 290674 0
14/03/2014
Ethics approval number [1] 290674 0
HREC-D 014/14

Summary
Brief summary
Glucose sensor technology has been evolving with an ultimate goal of achieving a level of accuracy required for finger-prick capillary glucose measurement replacement and reliability needed for consistent closed-loop functionality. While there have been recent advances in CGM technology, further improvements relating to sensor accuracy and reliability are required.
Glucose sensor redundancy (the incorporation of multiple sensing elements onto a single sensor) represents the next logical step toward the ultimate goal of achieving a level of accuracy and reliability required for a stand-alone glucose monitor and a closed-loop system.
The Harmony Sensor represents an advance in electro-chemical sensor design and incorporates a redundant sensor system. The Harmony sensor consists of a unique electro-chemical sensor in a fold-over design, so that there are sensing elements on both planar surfaces.
This feasibility study will assess the accuracy and reliability of the redundant electrochemical sensor (Harmony) for CGM compared to YSI values and meter glucose values.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46622 0
A/Prof David O'neal
Address 46622 0
Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 46622 0
Australia
Phone 46622 0
+61 3 9288 2211
Fax 46622 0
Email 46622 0
[email protected]
Contact person for public queries
Name 46623 0
Amin Sharifi
Address 46623 0
Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 46623 0
Australia
Phone 46623 0
+61 3 9288 2211
Fax 46623 0
Email 46623 0
[email protected]
Contact person for scientific queries
Name 46624 0
Amin Sharifi
Address 46624 0
Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 46624 0
Australia
Phone 46624 0
+61 3 9288 2211
Fax 46624 0
+61 3 9288 2211
Email 46624 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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