Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001572853
Ethics application status
Approved
Date submitted
11/10/2021
Date registered
18/11/2021
Date last updated
3/11/2022
Date data sharing statement initially provided
18/11/2021
Date results information initially provided
3/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Needle-free Blood Glucose Sensing
Scientific title
Needle-free Jet Injection with suction to Measure Glucose Concentration in Capillary Blood for Diabetes
Secondary ID [1] 305403 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 323834 0
Condition category
Condition code
Metabolic and Endocrine 321340 321340 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be subjected to four capillary blood sampling interventions. These interventions will be performed on the side of the fingertip of the middle (3rd finger) and ring finger (4th finger) of either hand.

Two of the four interventions will use a lancet to prick the finger to release the capillary blood sample. This is the current gold standard recommended by the WHO. Suction will be applied to the fingertip following one of the finger pricks.

The other two interventions will use a needle-free jet injection device in place of the lancet to break the skin. This injection device will use a thin stream of fluid (<0.05 mL) to break the skin, targeting the same penetration depth as a lancet (2.3 mm). The fluid used by the injector will be isotonic saline solution marked with a very low concentration (10 mg/L) of Indocyanine Green (ICG). ICG is an FDA approved fluorescent marker typically used in the body at a concentration of 5 g/L. Suction will be applied to the fingertip following one of the finger pricks.

The study is divided into three arms that differ only in the magnitude of the suction pressure applied following two of the four interventions. All participants will receive the same 2 lancet pricks and 2 jet injections, one jet injection and one lancet prick will then be followed by the application of suction. Participants will be randomly assigned to one of the arms as follow:

Arm 1: -20 kPa pressure applied following 2/4 interventions
Arm 2: -40 kPa pressure applied following 2/4 interventions
Arm 3: -60 kPa pressure applied following 2/4 interventions

All participants will receive all four interventions, however, the order and location (which fingertip) of each intervention will be randomised. The time between each intervention will be approximately 5 minutes. The interventions will be performed by a study researcher with a nurse present. A checklist will be prepared in advance of the study that includes the randomised sequence of interventions to ensure adherence to protocol.
Intervention code [1] 321883 0
Treatment: Devices
Comparator / control treatment
Each participant will be subjected to a lancet prick based method of capillary blood sampling. This is the current best practice recommended by the WHO. As such each participant will serve as their own control.
Control group
Active

Outcomes
Primary outcome [1] 329153 0
Blood Volume. Measured by area of blood in a picture taken of blood within a capillary with known internal dimensions
Timepoint [1] 329153 0
A single measurement will be made on each of the blood samples within 2 hrs following the interventions.
Primary outcome [2] 329154 0
Dilution of blood sample.
Measured using a custom fluorimeter which indicates the concentration of indocyanine green (ICG)in the sample. As a small, known volume of ICG is present in the fluid used to break the skin this provides a measure of the amount of this fluid present in the blood sample.
Timepoint [2] 329154 0
A single measurement will be made on each of the blood samples within 2 hrs following the interventions.
Secondary outcome [1] 401662 0
Perceived pain, using visual analog scale.
Timepoint [1] 401662 0
Measured immediately after each intervention.
Secondary outcome [2] 401663 0
Blood glucose concentration. Measured using point of care glucometer (CareSens N).
Timepoint [2] 401663 0
A single measurement will be made on each of the blood samples within 2 hrs following the interventions.
Secondary outcome [3] 401664 0
Perceived ongoing pain.
Measured using study specific questionnaire.
Timepoint [3] 401664 0
Questionnaire will be completed 24hrs after the interventions

Eligibility
Key inclusion criteria
Aged between 20 and 60 years old.
Able to communicate in English
Able to give full informed consent (i.e. no neurological impairment)
Minimum age
20 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Insulin-dependent diabetes
Haemophilia (or other bleeding/clotting disorders)
Carrier of blood-borne infectious agent (e.g. HIV, HBV)
Reduced peripheral circulation (eg. from Raynaud’s disease or beta blocker use)
Amputation affecting a number of fingertips
Allergy to iodides and/or indocyanine green

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
statistical power calculations were made for group sizes of 5 participants to enable the establishment of significant differences in the mean volume released as low as 1.4 µL (s_BloodVolume= 0.7 µL, a= 0.05, ß= 0.1). Differences in mean blood dilution as low as 6 % between groups (s_fluorimeter= 3 % , a= 0.05, ß= 0.1). Differences between groups whose mean glucose concentration differs by as little as 10 % (s_glucometer= 0.28 mmol/L, a= 0.05, ß= 0.1).

Comparisons of results will be conducted using t-tests and related methods to assess differences in measured values across interventions

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2021
Actual
20/06/2022
Date of last participant enrolment
Anticipated
21/01/2022
Actual
23/09/2022
Date of last data collection
Anticipated
21/01/2022
Actual
23/09/2022
Sample size
Target
15
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 24170 0
New Zealand
State/province [1] 24170 0
Auckland

Funding & Sponsors
Funding source category [1] 309766 0
Government body
Name [1] 309766 0
New Zealand Ministry of Business, Innovation and Employment
Country [1] 309766 0
New Zealand
Primary sponsor type
Individual
Name
Professor Andrew Taberner
Address
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 310794 0
University
Name [1] 310794 0
University of Auckland
Address [1] 310794 0
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 310794 0
New Zealand
Secondary sponsor category [2] 310877 0
Individual
Name [2] 310877 0
James Mckeage
Address [2] 310877 0
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
Country [2] 310877 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309523 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 309523 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 309523 0
New Zealand
Date submitted for ethics approval [1] 309523 0
21/10/2021
Approval date [1] 309523 0
14/12/2021
Ethics approval number [1] 309523 0
2021 FULL 11035

Summary
Brief summary
Type 1 and insulin dependent type 2 diabetics require injections of insulin multiple times per day to manage the glucose concentration in their blood. The appropriate dose of insulin is determined using a measurement of blood glucose concentration that typically requires the fingertip be pricked with a lancet. The drop(s) of blood resulting from this prick are used to perform the glucose measurement. In an effort to make this process easier for diabetics, we are investigating whether glucose testing can be integrated into a needle-free jet injection device, thus totally avoiding the need for a lancet to prick the skin. Performing this process without a needle/lancet will avoid the associated issues of sharps waste, accidental needle stick, and needle-phobia.

Towards this goal, we recently completed a study investigating the relationship between the shape of a jet injection and the volume of blood released. This study demonstrated that enough blood was released by jet injection for a glucose test, although the jet injection released less blood than a lancet. We believe that by applying a small suction cup after jet injection, we can significantly increase the volume of blood released. By enhancing the volume of blood released in this way, we want to collect a sample with the least discomfort to the participant possible.

We now wish to perform a pilot study aiming to assess the feasibility of using a jet injector assisted by suction to retrieve a capillary blood sample. Each participant in the study will receive four interventions: a lancet prick, a lancet prick with suction applied, a jet injection, and a jet injection with suction applied. Participants will be aware they are receiving one of each intervention, but will be blinded to the order and which intervention is occurring at which site.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114450 0
Prof Andrew Taberner
Address 114450 0
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand
Country 114450 0
New Zealand
Phone 114450 0
+64 9 923 5024
Fax 114450 0
Email 114450 0
[email protected]
Contact person for public queries
Name 114451 0
Prof Andrew Taberner
Address 114451 0
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand
Country 114451 0
New Zealand
Phone 114451 0
+64 9 923 5024
Fax 114451 0
Email 114451 0
[email protected]
Contact person for scientific queries
Name 114452 0
Prof Andrew Taberner
Address 114452 0
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand
Country 114452 0
New Zealand
Phone 114452 0
+64 9 923 5024
Fax 114452 0
Email 114452 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
Given the extent of device specific and laboratory specific measurement involved in this trial it is best only to publicly release the analysed data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13461Study protocol    382848-(Uploaded-07-10-2021-11-51-24)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 382848-(Uploaded-02-11-2022-12-36-54)-Basic results summary.docx
Plain language summaryNo We have found that the application of suction sign... [More Details]

Documents added automatically
No additional documents have been identified.