Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000537651
Ethics application status
Approved
Date submitted
17/05/2023
Date registered
22/05/2023
Date last updated
22/05/2023
Date data sharing statement initially provided
22/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
First-in-human Testing of a Multi-Analyte Sensor Platform for Glucose/Lactate/Oxygen/Choline in People with Diabetes
Scientific title
Accuracy and Feasibility of a Novel Glucose/Lactate/Oxygen/Choline Multi-Analyte Sensing Platform in Humans
Secondary ID [1] 309674 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 330032 0
Condition category
Condition code
Metabolic and Endocrine 326938 326938 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a single site feasibility study to collect data on the glucose/lactate and lactate/choline/oxygen sensor performance of a multianalyte sensor platform. There will be no randomisation of participants. The data will not be blinded to the investigators. Data from study devices will not impact upon decisions involving care of the participants as sensor generated glucose or other analyte data will not be available to the participants. All participants will wear the investigational sensing platform for the approximate 3-4 day duration. Each participant will wear the following:
• Two separate multi-analyte sensors (glucose/lactate and lactate/choline/oxygen) inserted subcutaneously preferably in the upper arm area and connected to a data recorder.
• A commercially available continuous glucose monitor inserted in the upper arms of the participant.
If the participant is managed with multiple daily injections, they will continue to administer rapid acting and intermediate/ basal insulin as per established regimens. If the participant is managed using an insulin pump they will continue to infuse subcutaneous rapid acting insulin as per the participant’s established insulin pump infusion protocols.
Participation in this research study will occur over approximately 3-4 days and participants will be required to attend the clinical trials centre at St Vincent’s Hospital, Melbourne twice, on day 1 and day 4. On the first study day, participants will attend the trials centre at ~7:30AM having fasted overnight (unless required to treat a hypoglycemic event). The first study visit will run for approximately 7 hours. Informed consent will be obtained from all participants. If a participant meets all screening eligibility criteria, he or she will be considered enrolled into the study. Participant demographic and baseline characteristics, including age, gender, race, ethnicity, and medical diagnosis will be collected during this visit. A trained study investigator will insert the investigational and study sensors. The insertion of the investigational sensors is comparable to commercially available interstitial sensors.
Immediately after sensor insertion and warm-up, a meal test followed by a high-intensity exercise challenge will occur, resulting in acute increases in glucose and lactate respectively. Blood glucose levels are to be between 4.0-15.0 mmol/L and blood ketones are to be <0.6 mmol/L prior to commencing the test meal protocol. A standardised test meal containing 65g carbohydrate will be consumed by each participant immediately following sensor insertion and sensor warm-up. Participants will administer 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 lactate (YSI) levels will be measured immediately following sensor insertion (baseline) and every 15min following the test-meal for four hours. Four hours following the meal test, participants will undergo 40min of high-intensity exercise. This will involve 40 minutes of exercise on the cycle ergometer, including 5x4min ‘hard’ intervals, interspersed with 4min rest. The 4min ‘hard’ intervals will be performed at an intensity that elicits approximately 80-90% of the participants’ age-predicted heart rate maximum, and a perceived rating of exertion (RPE) of 8-10, on a 10-point scale. This protocol has been previously demonstrated by our group to produce a significant lactate excursion in people with type 1 diabetes. During exercise venous blood samples for glucose and lactate will be collected at 5-minute intervals and then at 10-minute intervals until the end of the study visit, which will occur 60min after exercise completion.
Following the initial visit, participants will continue wearing the sensors at home on Days 2 and 3. Participants will be instructed to monitor glucose levels at home a minimum of 8 times a day (pre-meals and 2 hours post-meals) between visits. Glucose readings will be recorded along with the amount and timing of insulin injected and a log of exercise/physical activity in a diary. Any exercise for 10 minutes duration or longer will be recorded, along with the type and intensity of the exercise performed. Fingerprick blood lactate readings will also occur at least 3 times per day, at any time (for ease, measurements can be taken at the same time as glucose). Additionally, fingerprick blood lactate readings should occur after any exercise performed in the study window.
The second study visit will occur on Day 4 of the study. The second visit will involve the same protocol as in visit 1 (without sensor insertion), repeating the Meal Test and Exercise Test. This study visit will last for approximately 6-7 hours. Participants will have the investigational and study devices removed following the testing procedures and will exit the study.
Intervention code [1] 326116 0
Treatment: Devices
Comparator / control treatment
The investigational multi-analyte sensor will be compared against multiple comparators:
- The glucose sensor will be compared with a current commercially available glucose sensor
- Both glucose and lactate sensors will be compared with current commercially available point-of-care handheld meters using fingerprick blood samples, and on trial days with YSI glucose/lactate measurements on venous blood
- The oxygen sensor will be compared with iStat measurements on trial days
Control group
Active

Outcomes
Primary outcome [1] 334773 0
Comparison of the investigational sensor accuracy for glucose and lactate (including Day 1 vs. Day 4 performance and performance in the high vs. low glucose range) compared with point-of-care meter data, commercial continuous glucose sensor data and YSI glucose and lactate values as reference values.
Timepoint [1] 334773 0
Day 1 and Day 4 of wearing the investigational sensing platform
Secondary outcome [1] 422032 0
Descriptive comparison of differences in sensor lactate values for the two investigational lactate sensors between devices.
Timepoint [1] 422032 0
Day 1 and Day 4 of wearing the investigational sensing platform
Secondary outcome [2] 422033 0
Comparison of investigational sensor currents and retrospective accuracy of investigational sensor oxygen data
Timepoint [2] 422033 0
Day 1 and Day 4 of wearing the investigational sensing platform
Secondary outcome [3] 422034 0
Descriptive analysis of the investigational sensor currents for the choline sensor including stability over the study and response dynamics during challenge periods.
Timepoint [3] 422034 0
Day 1 and Day 4 of wearing the investigational sensing platform

Eligibility
Key inclusion criteria
Participants will be considered for inclusion in the study if they meet all of the following criteria:
1. Participant is 18-65 years of age at time of screening.
2. A clinical diagnosis of Type-1 diabetes, or Type-2 diabetes as determined by the Investigator.
3. Participant is willing to comply with all requirements associated with the protocol.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study for any of the following reasons:

1. Participant has experienced an episode of major hypoglycaemia or diabetic ketoacidosis within the last month
2. Participant has a major illness precluding safe implementation of the protocol
3. Participant is or plans to become pregnant during the course of the study.
4. Participant is unable to tolerate tape adhesive in the area of sensor placement.
5. Participant has any unresolved adverse skin condition in the area of 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
1/06/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
14/10/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313866 0
Charities/Societies/Foundations
Name [1] 313866 0
The Leona M. and Harry B. Helmsley Charitable Trust.
Country [1] 313866 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 315707 0
None
Name [1] 315707 0
Address [1] 315707 0
Country [1] 315707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313015 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 313015 0
Ethics committee country [1] 313015 0
Australia
Date submitted for ethics approval [1] 313015 0
Approval date [1] 313015 0
21/04/2023
Ethics approval number [1] 313015 0

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

Contacts
Principal investigator
Name 126686 0
Prof David O'Neal
Address 126686 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 126686 0
Australia
Phone 126686 0
+61 3 9288 2012
Fax 126686 0
Email 126686 0
[email protected]
Contact person for public queries
Name 126687 0
Dale Morrison
Address 126687 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 126687 0
Australia
Phone 126687 0
+61 92314164
Fax 126687 0
Email 126687 0
[email protected]
Contact person for scientific queries
Name 126688 0
David O'Neal
Address 126688 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 126688 0
Australia
Phone 126688 0
+61 3 9288 2012
Fax 126688 0
Email 126688 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.