Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000466549
Ethics application status
Approved
Date submitted
12/03/2024
Date registered
16/04/2024
Date last updated
16/04/2024
Date data sharing statement initially provided
16/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Seven Day Study of the SynerG Combined Insulin-Delivery and Glucose Sensory System in Persons with Type 1 Diabetes
Scientific title
A Seven Day Study of the SynerG TM Insulin-Delivery and Glucose Sensor System in Persons with Type 1 Diabetes
Secondary ID [1] 311662 0
none
Universal Trial Number (UTN)
Trial acronym
SLC-7
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 333119 0
Condition category
Condition code
Metabolic and Endocrine 329810 329810 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study participants will have an experimental combined insulin cannula and glucose sensor (SynerG) delivering insulin via an insulin pump. The device will be inserted subcutaneously and will deliver the insulin via the commercially available Medtronic 780G or Tandem T-Slim insulin pump which is also inserted into the participant. The overall system is therefore the SynerG (combined cannula and glucose sensor) with the commercially available insulin pump, and there is no control device. The system will be inserted by the study staff, and used on the participant's usual insulin delivery settings. The participants may use Basal-IQ (Tandem) or the fully open-loop system (Tandem or Medtronic). The participants will also have a Dexcom G6 Continuous Glucose Monitor (CGM) system inserted.

The study period will involve a 7 day period of wearing the SynerG device with the Medtronic 780G or Tandem T-Slim insulin pump. The participants will wear the devices for 24 hours a day, for 7 days. Data from the insulin pumps will be able to used to assess for adherence to the devices. There will be three mixed meal tests throughout the 7 day period on days 1,4 and 7, with free living days in between. The mixed meal test will last over 4-5 hours with 15 minutely interval blood sampling. The mixed meal test will involve 30-60g carbohydrates + 10g protein + 10g fat with the goal of accumulating glucose values in the hypoglycaemic, euglycaemic and hyperglycaemic ranges. Experimental device CGM data will be collected throughout the seven days. Experimental device CGM accuracy will be compared with reference Yellow Springs Instruments (YSI) blood glucose level (BGL) as well as commercially available Dexcom G6 CGM readings.
Intervention code [1] 328125 0
Treatment: Devices
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337583 0
Glucose sensor accuracy
Timepoint [1] 337583 0
Over a 7-day duration - during mixed meal tests on day 1, 4 and 7 after experimental device insertion. Experimental device glucose sensor readings (which will be continuous glucose readings) will be compared to 15 minutely blood samples tested via YSI glucose analyser and finger test strips during the mixed meal tests - over a 4-5 hour period on those days.
Primary outcome [2] 337584 0
Infusion set survival
Timepoint [2] 337584 0
Infusion set failure defined by any of the above over a 7 day period, from insertion (day 1) to day 7 of trial. Primary timepoint would be day 7, to see if in the infusion set lasts the full 7 days. Glucose readings will be done via continuous glucose monitoring on the experimental device. Blood ketone readings will be done during mixed meal tests if the patients blood glucose is greater than 13.9 mmol/L and/or the participant is nauseated or vomiting.
Secondary outcome [1] 432379 0
Participant tolerability of the SynerG system
Timepoint [1] 432379 0
Over 7-day duration
Subjective discomfort at insertion questionnaire will be done 10min post insertion of intervention (on Day 1)
Subjective discomfort questionnaire at night or other times will be done on end of study visit (day 7) and ask regarding discomfort for the entire 7 day period.
Erythema or oedema at cannula site will be assessed by study staff on removal of device, at end of study visit (day 7)

Eligibility
Key inclusion criteria
1. T1D, of at least 6 months duration.
2. Age 18-75
3. Insulin pump usage at the time of screening and for at least 3 months prior to screening
4. HbA1c between 5.8 and 10%
5. Willingness and ability to follow all study procedures and to attend all clinic visits.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Skin reactions and infections.
2. History of recurrent infusion site failure.
3. Any other major medical or psychiatric condition which in the opinion of the investigator would preclude safe implementation of the protocol.
4. Vulnerable population ie. Children/neonates, Pregnant women, cognitively impaired adults, prisoners.

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
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/04/2024
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
45
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315990 0
Commercial sector/Industry
Name [1] 315990 0
Pacific Diabetes Technology
Country [1] 315990 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent’s Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318136 0
None
Name [1] 318136 0
Address [1] 318136 0
Country [1] 318136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314815 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314815 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 314815 0
Australia
Date submitted for ethics approval [1] 314815 0
05/09/2023
Approval date [1] 314815 0
08/11/2023
Ethics approval number [1] 314815 0

Summary
Brief summary
This study will evaluate the accuracy of an experimental CGM measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy. Glucose sensory accuracy will be measured over a 7 days period, along with device survival and tolerability over the same period. Accuracy of the device will be tested in both a free living state, as well as over three seperate mixed meal challenges in order to test the device accuracy over a range of glucose levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132814 0
Prof David O'Neal
Address 132814 0
St Vincent's Hospital Melbourne, 41 Victoria Parade,Fitzroy 3065, Victoria
Country 132814 0
Australia
Phone 132814 0
+61 425731665
Fax 132814 0
Email 132814 0
dno@unimelb.edu.au
Contact person for public queries
Name 132815 0
Ms Catriona Sims
Address 132815 0
The University of Melbourne, Department of Medicine, 41 Victoria Parade, Fitzroy 3065, Victoria
Country 132815 0
Australia
Phone 132815 0
+61 417482010
Fax 132815 0
Email 132815 0
catriona.sims@unimelb.edu.au
Contact person for scientific queries
Name 132816 0
David O'Neal
Address 132816 0
St Vincent's Hospital Melbourne, 41 Victoria Parade,Fitzroy 3065, Victoria
Country 132816 0
Australia
Phone 132816 0
+61 425731665
Fax 132816 0
Email 132816 0
dno@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.