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Trial registered on ANZCTR


Registration number
ACTRN12617000919314
Ethics application status
Approved
Date submitted
12/06/2017
Date registered
22/06/2017
Date last updated
22/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of a long-term continuous glucose monitor in type 1 diabetes
Scientific title
Accuracy of long-term implantable glucose monitoring in type 1 diabetes
Secondary ID [1] 292129 0
None
Universal Trial Number (UTN)
U1111-1197-7246
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 303556 0
Condition category
Condition code
Metabolic and Endocrine 302965 302965 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed to provide frequently-sampled data from an investigational long-term continuous glucose monitor to optimise signal processing techniques and improve sensor performance.

The investigational device is a subcutaneously implanted metal sensor about the size of a large USB that is designed to measure interstitial glucose levels. The sensor contains a small battery and a transmitter that wirelessly transmits data from the device to a handheld receiver and is stored in the receiver’s memory for later download and processing. It is fully implantable i.e. nothing is worn on the skin and will remain in-situ for approximately 4 months. It will be implanted into the subcutaneous tissue of the lower abdomen by a qualified surgeon under local anaesthetic and light sedation.

Following implantation, the sensor requires no user interaction or maintenance, although the receiver needs to be kept close by to ensure that data packets are reliably recorded. The only maintenance required for the receiver is battery changes and download of receiver data.

Participants with type 1 diabetes will have the device implanted under local anaesthetic and will undergo weekly clinic visits during the 4 months of implanted sensor wear. Additionally, participants will undergo four meal-driven glucose excursion visits where hourly capillary blood finger-prick and 15-minute venous blood glucose sampling will occur for up to 8 hours. Once per month, at one of the weekly visits, participants will be asked to wear an activity tracker and to complete the standing and sitting activity over a 1-hour and 15-minute period. Finger-prick glucose measurement will be performed before and after the one hour and 15-minute data collection.

Between clinical site visits, participants will carry a data logger receiver that records signal outputs from the implanted sensor (display shows date/time, but no glucose information), change the AAA batteries in the study receiver daily and confirm the receiver is receiving data, self-monitor blood glucose (SMBG) a minimum of 4 times per day, respond to daily text or phone call confirming the receiver is working with an appropriate date / time and record study activities in a participant diary.

Trial participants will be provided with a commercially approved continuous glucose monitor (CGM) for use during the study and participants will be trained on the use of the CGM by the study site. Participant data from the CGM (de-identified) will be downloaded during the monthly in-clinic visit.

Explantation of the sensor may occur immediately following the final meal excursion visit or up to 4 months and 20 days from the date of implant. The explantation procedure, in general, mimics the implantation procedure and is performed under local anaesthetic.
Intervention code [1] 298272 0
Treatment: Devices
Comparator / control treatment
Continuous glucose monitor values
Venous blood glucose values
Finger prick blood glucose measurements
Control group
Active

Outcomes
Primary outcome [1] 302360 0
Investigational sensor MARD, compared with reference venous blood glucose measurements
Timepoint [1] 302360 0
During four in-clinic visits approximately one month apart
Secondary outcome [1] 335847 0
Investigational sensor MARD, compared with finger prick blood glucose measurements
Timepoint [1] 335847 0
At least 4x/day during at-home periods throughout the 16-week trial duration
Secondary outcome [2] 335848 0
Investigational sensor MARD, compared with reference venous blood glucose measurements during different controlled physical movements and activities
Timepoint [2] 335848 0
Once per month
Secondary outcome [3] 335886 0
Investigational sensor MARD, compared with reference continuous glucose sensor measurements
Timepoint [3] 335886 0
During at-home periods throughout the 16-week trial duration

Eligibility
Key inclusion criteria
* Type 1 diabetes mellitus for at least 5 years
* HbA1c <10%
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Serious chronic illness
* Use of paracetamol during the trial

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
Not yet recruiting
Date of first participant enrolment
Anticipated
27/06/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8307 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 16370 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 296667 0
Commercial sector/Industry
Name [1] 296667 0
GlySens Incorporated
Country [1] 296667 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Pde
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 295626 0
None
Name [1] 295626 0
Address [1] 295626 0
Country [1] 295626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297892 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 297892 0
Ethics committee country [1] 297892 0
Australia
Date submitted for ethics approval [1] 297892 0
Approval date [1] 297892 0
25/05/2017
Ethics approval number [1] 297892 0
HREC 081/17

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

Contacts
Principal investigator
Name 75382 0
A/Prof David O'Neal
Address 75382 0
St Vincent's Hospital Melbourne
35 Victoria Pde Fitzroy VIC 3065
Country 75382 0
Australia
Phone 75382 0
+61 3 9231 2211
Fax 75382 0
Email 75382 0
dno@unimelb.edu.au
Contact person for public queries
Name 75383 0
Barbora Paldus
Address 75383 0
St Vincent's Hospital Melbourne
35 Victoria Pde Fitzroy VIC 3065
Country 75383 0
Australia
Phone 75383 0
+61 3 9231 2211
Fax 75383 0
Email 75383 0
barbora.paldus@svha.org.au
Contact person for scientific queries
Name 75384 0
Sybil McAuley
Address 75384 0
St Vincent's Hospital Melbourne
35 Victoria Pde Fitzroy VIC 3065
Country 75384 0
Australia
Phone 75384 0
+61 3 9231 2211
Fax 75384 0
Email 75384 0
sybil.mcauley@svha.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Embase3D biosensors in advanced medical diagnostics of high mortality diseases.2019https://dx.doi.org/10.1016/j.bios.2018.12.057
N.B. These documents automatically identified may not have been verified by the study sponsor.