Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001516875
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
8/11/2021
Date last updated
8/11/2021
Date data sharing statement initially provided
8/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility Trial to Evaluate the Eclipse 3 Continuous Glucose Monitoring System - Australia (FREE - AU Trial)
Scientific title
Feasibility Trial to Evaluate the Eclipse 3 Continuous Glucose Monitoring System for Individuals with Type 1 Diabetes Mellitus - Australia (FREE - AU Trial)
Secondary ID [1] 304836 0
Nil
Universal Trial Number (UTN)
Trial acronym
FREE-AU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 322923 0
Condition category
Condition code
Metabolic and Endocrine 320496 320496 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is designed to evaluate device tolerance and safety of the Eclipse 3 CGM System, a third-generation sensor design in a small group of participants. Additionally, this limited scope trial will help to determine whether the new design elements incorporating a smaller sensor (approximately 40% smaller than the prior design), modernized functionality and optimized sensor signal processing techniques have resulted in improved sensor performance.

6-8 participants are expected to be enrolled in this study and the sensor will be implanted into the participant’s lower abdominal area and remain there for a minimum of four
and a half months and up to eight months, after which it will be removed. The sensor implant requires a minor 30 minute surgical operation usually achieved under local anaesthesia with some intravenous sedation in which the surgeon will complete a small incision in the lower abdomen to implant the sensor. At the end of the study, another minor surgical operation using the same technique is required to remove the sensor.

Throughout the course of the trial, device properties and safety assessments will be made to determine device function. Participants will attend the clinical site weekly post device implant for up to 2 weeks to evaluate wound healing, and then at monthly intervals to undergo meal testing and frequent blood sampling. Blood samples taken during the monthly visits will assess device safety and determine if the protocol will be terminated at 4.5 months, or up to 8 months.

Participants will be required to test their blood glucose daily by fingerprick a minimum of 4 times per day and fill out a diary each week to monitor adherence to the study requirements. The study diary will be reviewed at each visit.
Intervention code [1] 321216 0
Treatment: Devices
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328326 0
Evaluate safety of the implanted 3rd generation Eclipse 3 sensor through testing of provided serum retention samples for anti-glucose oxidase and anti-catalase antibodies at specified time-periods, monthly blood chemistry panels and assessment of any adverse device effects (following definitions as described in ISO 14155:2020)..
Timepoint [1] 328326 0
Safety parameters for anti-glucose Oxidase and Anti-catalase antibodies will be assessed at Day-7 Post implant, Months 1, 4 and 7 and Day 14-post explant. Other safety parameters will be assessed monthly until the study ends or is ceased due to safety concerns.
Primary outcome [2] 328327 0
Reliability (performance) of wireless communication between the Eclipse 3 Sensor and the study provided receiving device assessed as the percentage of possible data packets received for the implant duration.
Timepoint [2] 328327 0
Evaluated at each monthly visit for up to 8 months
Secondary outcome [1] 398619 0
Assess device tolerance (participants’ experience) of the GlySens Eclipse 3 System and conventional CGM as utilized in the trial measured through standardized participant questionnaires designed specifically for GlySens Clinical Trials..
Timepoint [1] 398619 0
Assessed Monthly for up to 8 months
Secondary outcome [2] 398620 0
Evaluate tissue characteristics adjacent to the implanted devices through histological analysis of tissue specimens obtained upon device removal
Timepoint [2] 398620 0
Assessed at Device Explant

Eligibility
Key inclusion criteria
* Type 1 diabetes mellitus for at least 5 years
* HbA1c <10%
* BMI < 35kg/m2
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Serious chronic illness
* c-peptide <150pmol/L

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
Safety
Statistical methods / analysis
Data obtained from a limited sample size, therefore no formal statistical considerations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/10/2021
Date of last participant enrolment
Anticipated
25/11/2021
Actual
Date of last data collection
Anticipated
17/10/2022
Actual
Sample size
Target
8
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20037 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 34745 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 309209 0
Commercial sector/Industry
Name [1] 309209 0
GlySens Incorporated
Country [1] 309209 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Barons Medical Consulting Pty Ltd
Address
25-27 Granard Avenue,Park
Orchards, VIC, 3114Australia
Country
Australia
Secondary sponsor category [1] 310171 0
Commercial sector/Industry
Name [1] 310171 0
GlySens Incorporated
Address [1] 310171 0
3931 Sorrento Valley Blvd
Suite 110
San Diego, CA 92121
Country [1] 310171 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309060 0
St Vincent’s Hospital (Melbourne) Human Research Ethics Committee
Ethics committee address [1] 309060 0
41 Victoria Parade, Fitzroy, VIC 3065
Ethics committee country [1] 309060 0
Australia
Date submitted for ethics approval [1] 309060 0
17/03/2021
Approval date [1] 309060 0
29/04/2021
Ethics approval number [1] 309060 0
HREC 062/21

Summary
Brief summary
This study is to assess the Eclipse 3 Continuous Glucose Monitoring System device (CGM). The Eclipse 3 system is comprised of an implantable CGM (sensor) paired with a mobile App that is designed to capture blood glucose readings in real time. The purpose of this research project is to test the safety and performance of the Eclipse 3 CGM System over a 4 to 8 month period. Six to eight participants who have had type 1 diabetes for at least 5 years, and are using insulin will be enrolled. This sensor will be implanted below the skin into the lower abdominal area and remain there for a minimum 4.5 up to a maximum of 8.5 months . Participants will come in monthly for visits. After 4 months of participation, data from the implanted sensor will be evaluated to determine whether or not participants will continue for the next 2 months. Should the participants continue to have the sensor implanted for an additional 2 months, they will continue to come in for monthly visits. At the 6month mark they will again have their data evaluated to determine if they will continue to have the sensor implanted for an additional 2 months up to a maximum of 8 months. After the 8 month visit (unless determined to be after Month 4 or Month 6) the sensor will be explanted and a biopsy of the tissue will be retrieved for evaluation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112830 0
Prof David O'Neal
Address 112830 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 112830 0
Australia
Phone 112830 0
+61 3 9288 2012
Fax 112830 0
Email 112830 0
[email protected]
Contact person for public queries
Name 112831 0
Mrs Sandra Martha
Address 112831 0
GlySens Incorporated, 3931 Sorrento Valley Blvd Suite 110, San Diego, CA 92131
Country 112831 0
United States of America
Phone 112831 0
+1 858 6387708
Fax 112831 0
Email 112831 0
[email protected]
Contact person for scientific queries
Name 112832 0
Mr Ted Williams
Address 112832 0
GlySens Incorporated, 3931 Sorrento Valley Blvd Suite 110, San Diego, CA 92131
Country 112832 0
United States of America
Phone 112832 0
+1 858 6387708
Fax 112832 0
Email 112832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4166Plain language summaryNo Study data supports participant acceptance and saf... [More Details]

Documents added automatically
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