ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Blood Volume. Measured by area of blood in a picture taken of blood within a capillary with known internal dimensions

Timepoint [1]

A single measurement will be made on each of the blood samples within 2 hrs following the interventions.

Primary outcome [2]

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]

A single measurement will be made on each of the blood samples within 2 hrs following the interventions.

Secondary outcome [1]

Perceived pain, using visual analog scale.

Timepoint [1]

Measured immediately after each intervention.

Secondary outcome [2]

Blood glucose concentration. Measured using point of care glucometer (CareSens N).

Timepoint [2]

A single measurement will be made on each of the blood samples within 2 hrs following the interventions.

Secondary outcome [3]

Perceived ongoing pain.
Measured using study specific questionnaire.

Timepoint [3]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

New Zealand Ministry of Business, Innovation and Employment

Address [1]

15 Stout Street, Wellington 6011

PO Box 1473, Wellington 6140

Country [1]

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]

University

Name [1]

University of Auckland

Address [1]

Private Bag 92019
Auckland 1142
New Zealand

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

James Mckeage

Address [2]

Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

21/10/2021

Approval date [1]

14/12/2021

Ethics approval number [1]

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

Prof Andrew Taberner

Address

Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand

Country

New Zealand

Phone

+64 9 923 5024

Fax

a.taberner@auckland.ac.nz

Contact person for public queries

Name

Andrew Taberner

Address

Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand

Country

New Zealand

Phone

+64 9 923 5024

Fax

a.taberner@auckland.ac.nz

Contact person for scientific queries

Name

Andrew Taberner

Address

Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand

Country

New Zealand

Phone

+64 9 923 5024

Fax

a.taberner@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
13461	Study protocol					382848-(Uploaded-07-10-2021-11-51-24)-Study-related document.docx

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically