Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000701426
Ethics application status
Approved
Date submitted
18/06/2025
Date registered
2/07/2025
Date last updated
2/07/2025
Date data sharing statement initially provided
2/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility Study of a Combined Glucose and Ketone Sensor in People with and without Diabetes
Scientific title
A Feasibility Study of a Prototype Combined Glucose-Ketone Sensor in Humans
Secondary ID [1] 314360 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 337873 0
Condition category
Condition code
Metabolic and Endocrine 334201 334201 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants enrolled at St Vincent's Hospital Melbourne will continuously wear a combined glucose and ketone monitor (CGKM) over 72 hours under free-living conditions. Standardized meal and ketone drink tests in the clinical trial centre including frequent blood sampling will be performed on Day 1 (the day of sensor insertion) and Day 4 (the final day of study). All sensor data will be masked to participants and total duration of sensor wear and persistence of sensor signal will be monitored throughout the intervention.

The prototype CKGM device consists of a sensor probe inserted transcutaneously and an optoelectronic wireless wearable (OEW) device connected to the inserted probe and placed on the surface of the skin, aligned above the inserted probe. The CKGM measures interstitial ketones (beta-hydroxybutyrate) and glucose directly, as well as oxygen partial pressure, which is used as a reference measurement to correct collected ketone and glucose values.

On the first and last day of CGKM wear, a standardised test meal containing 65g carbohydrate will be consumed by each participant. Participants with diabetes will administer half their usual insulin dose using either an injection or an insulin pump immediately prior to the meal. Venous blood glucose (study meter and YSI) and ketones (meter) levels will be measured immediately following sensor insertion (baseline) and every 15min following the test-meal for four hours.

Three hours following the meal test, participants will ingest a ketone ester drink (at ~12:00PM - 573mg/kg of ketone ester in ~100mL water/solution). Venous blood samples for glucose and ketones will be collected at 15-minute intervals until the end of the study visit, which will occur 120 min after the ketone drink has been ingested (~2:00PM).
Intervention code [1] 331298 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341862 0
The proportion of investigational devices achieving a viable ketone sensor signal for the study duration.
Timepoint [1] 341862 0
In total minutes from 0-72h post sensor insertion.
Secondary outcome [1] 448830 0
Proportion of sensor devices achieving a viable sensor signal for the duration of the study.
Timepoint [1] 448830 0
72h post-insertion
Secondary outcome [2] 449053 0
Duration of device survival for the ketone sensor.
Timepoint [2] 449053 0
Percentage of time across the entire study duration (0-72h)
Secondary outcome [3] 448829 0
Duration of device survival for the glucose sensor.
Timepoint [3] 448829 0
Percentage of time across the entire study duration (0-72h)
Secondary outcome [4] 448831 0
Estimated sensor delay.
Timepoint [4] 448831 0
An average of all recorded timepoints from 0-72h post-sensor insertion.
Secondary outcome [5] 448827 0
Comparison of investigational sensor outputs and retrospective accuracy of the investigational sensor glucose data.
Timepoint [5] 448827 0
Day 1 and Day 4, as well as comparison of Day 1 vs. Day 4.
Secondary outcome [6] 448828 0
Comparison of investigational sensor outputs and retrospective accuracy of the investigational sensor ketone data.
Timepoint [6] 448828 0
Day 1 and Day 4, as well as comparison of Day 1 vs. Day 4.

Eligibility
Key inclusion criteria
1. Participant is >18 years of age at time of screening.
2. Healthy participants (n=10) or clinical diagnosis of Type-1 diabetes, or insulin requiring Type-2 diabetes (n=10) as determined by the Investigator.
3. Participant is willing to comply with all requirements associated with the protocol.
4. Participant can wear a CGM.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participant has experienced an episode of major hypoglycaemia or diabetic ketoacidosis within the last month
2. Participant has a major physical or psychiatric illness precluding safe implementation of the protocol
2. Participant is or plans to become pregnant during the study.
3. Participant is unable to tolerate tape adhesive with their sensor.
4. Participant has any unresolved adverse skin condition with 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
6/04/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318880 0
Charities/Societies/Foundations
Name [1] 318880 0
Helmsley Charitable Trust
Country [1] 318880 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321711 0
None
Name [1] 321711 0
Address [1] 321711 0
Country [1] 321711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317494 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 317494 0
Ethics committee country [1] 317494 0
Australia
Date submitted for ethics approval [1] 317494 0
16/04/2025
Approval date [1] 317494 0
21/05/2025
Ethics approval number [1] 317494 0

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

Contacts
Principal investigator
Name 141234 0
Prof David O'Neal
Address 141234 0
University of Melbourne Department of Medicine, St Vincent's Hospital, 35 Victoria Parade, Fitzroy VIC 3065
Country 141234 0
Australia
Phone 141234 0
+61 03 9231 2574
Fax 141234 0
Email 141234 0
[email protected]
Contact person for public queries
Name 141235 0
David O'Neal
Address 141235 0
University of Melbourne Department of Medicine, St Vincent's Hospital, 35 Victoria Parade, Fitzroy VIC 3065
Country 141235 0
Australia
Phone 141235 0
+61 03 9231 2574
Fax 141235 0
Email 141235 0
[email protected]
Contact person for scientific queries
Name 141236 0
David O'Neal
Address 141236 0
University of Melbourne Department of Medicine, St Vincent's Hospital, 35 Victoria Parade, Fitzroy VIC 3065
Country 141236 0
Australia
Phone 141236 0
+61 03 9231 2574
Fax 141236 0
Email 141236 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.