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Trial registered on ANZCTR


Registration number
ACTRN12620001160921
Ethics application status
Approved
Date submitted
12/08/2020
Date registered
5/11/2020
Date last updated
5/11/2020
Date data sharing statement initially provided
5/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Function of Implanted Glucose Sensor – Performance and Sensor Variations Evaluation in Type 1 Diabetes
Scientific title
Function of Implanted Glucose Sensor – Performance and Sensor Variations Evaluation in Type 1 Diabetes
Secondary ID [1] 302015 0
Nil
Universal Trial Number (UTN)
Trial acronym
FIGS-PAVE
Linked study record
This study is a follow-on study from previous trials ACTRN12617000919314 and ACTRN12619000122156.

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 318576 0
Condition category
Condition code
Metabolic and Endocrine 316589 316589 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this research study is to collect data that can help to answer questions about the performance and safety of a new iteration of the surgically implanted Model 100 continuous glucose sensor. Trial participants will be randomized into two groups to evaluate performance. Sensors for the two groups will have been manufactured in the identical manner, with the sensor treatment (Dexamethasone with or without PEGylation) to be the only variation.

12 participants are expected to be enrolled in this study and the sensor will be implanted subcutaneously (just below the skin) 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 implant of the sensor requires a small incision in the lower abdomen which is placed as a minor surgical operation, usually achieved under local anaesthesia with some intravenous sedation in under 30 minutes. 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 and performance. Participants will attend the trials centre 1, 7 and 14 days after device implant for ~30mins, and then at monthly intervals for ~6 hours to undergo meal testing and blood sampling. Blood samples taken during thee monthly visits will assess device safety and determine if the protocol will be terminated at 4.5months, or up to 8 months.
Participants will be required to test their blood glucose daily by fingerprick between 4-8 times per day, and fill out a diary each week to monitor adherence to the study interventions. The study diary will be reviewed, and devices downloaded at each trial visit.
Intervention code [1] 318306 0
Treatment: Devices
Comparator / control treatment
Comparisons will be made between sensors treated with Dexamethasone with PEGylation (the unknown intervention) and sensors treated with Dexamethasone without PEGylation (the control/ comparator)
Control group
Active

Outcomes
Primary outcome [1] 324721 0
1. Using Model 200 Receivers, capture and record wirelessly transmitted data from implanted Model 100 Sensors in the two groups for assessment of device longevity.


Timepoint [1] 324721 0
Data regarding device longevity will be recorded continuously by the receiver and downloaded and recorded monthly until the study ends at 8 months, or is ceased for safety concerns.
Primary outcome [2] 325502 0
2. Evaluate the safety of the implanted device as measured through monitoring for anti-glucose oxidase and anti-catalase antibodies in blood samples at specified time-periods during the trial.
Timepoint [2] 325502 0
Safety parameters will be assessed monthly until the study ends at 8 months, or is ceased due to safety concerns.
Secondary outcome [1] 385561 0
The secondary outcomes of this study include:
1. Characterize circulating dexamethasone concentration in serum at monthly intervals.
Timepoint [1] 385561 0
Circulating dexamethasone will be assessed at monthly intervals while the device is implanted until completion of the study at 8 months, or the study is ceased for safety concerns.
Secondary outcome [2] 388213 0
2. Evaluation of tissue characteristics adjacent to the implanted devices through histological analysis of tissue specimens obtained upon device removal
Timepoint [2] 388213 0
Tissue characterization will occur upon removal of the device

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
* Use of paracetamol during the trial
* c-peptide <150pmol/L

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/08/2020
Date of last participant enrolment
Anticipated
11/11/2020
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
12
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306435 0
Commercial sector/Industry
Name [1] 306435 0
Glysens incorporated
Country [1] 306435 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
35 Victoria Pde, Fitzroy 3065, VIC Australia
Country
Australia
Secondary sponsor category [1] 306952 0
None
Name [1] 306952 0
Address [1] 306952 0
Country [1] 306952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306644 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 306644 0
Ethics committee country [1] 306644 0
Australia
Date submitted for ethics approval [1] 306644 0
Approval date [1] 306644 0
19/06/2020
Ethics approval number [1] 306644 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104530 0
Prof David O'Neal
Address 104530 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 104530 0
Australia
Phone 104530 0
+61 3 9288 2012
Fax 104530 0
Email 104530 0
dno@unimelb.edu.au
Contact person for public queries
Name 104531 0
Dale Morrison
Address 104531 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 104531 0
Australia
Phone 104531 0
+61 413137853
Fax 104531 0
Email 104531 0
dale.morrison@unimelb.edu.au
Contact person for scientific queries
Name 104532 0
Dale Morrison
Address 104532 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 104532 0
Australia
Phone 104532 0
+61 413137853
Fax 104532 0
Email 104532 0
dale.morrison@unimelb.edu.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.