ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001362189

Ethics application status

Approved

Date submitted

17/09/2019

Date registered

4/10/2019

Date last updated

3/12/2021

Date data sharing statement initially provided

4/10/2019

Date results provided

3/12/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Needle-free Sensing of Blood Glucose

Scientific title

Using Needle-free Jet Injection to Measure Glucose Concentration in Capillary Blood for Diabetes

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1240-5083

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 will be performed at four different finger tip sites on the participants by a medical proessional.
One of the four interventions will use a lancet to prick the finger to release the capillary blood sample. This is the current gold standard recommenended by the WHO.
The other three 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, targetting the same penetration depth as a lancet (2.3 mm).
The jet injections will be performed with isotonic saline as the injected fluid. All participants will recieve all four interventions, however the order and location (which figer-tip) of each intervention will be randomised. The time between each intervention will be approximately 5 minutes.

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 thier own control.

Control group

Active

Outcomes

Primary outcome [1]

Blood volume. Measured by the height of fluid collected into a cappilary tube of known 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.
The dilution will be implied based on the colour of the retrieved sample. A photograph will be taken under controlled lighting conditions to measure the colour.

Timepoint [2]

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

Secondary outcome [1]

Percieved 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]

Percieved ongoing pain.
Measured using study specific questionaire.

Timepoint [3]

Questionaire 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)
Amputation affecting a number of fingertips

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)

Subjects will be recruited into two different groups. Subjects will be aware of which group they are being recruited into and the differences between the groups. All recruitment and interventions on group 1 will be completed before recruiting participants into group 2.
Groups one and two differ only in the method by which sample dilution will be measured and the associated change in the injected fluid for this measurement. Participants in group 1 will recieve jet injections of isotonic saline and the dilution of the resulting blood samples will be infered by the colour of the sample. Participants in group 2 will recieve injections of isotonic saline containing 10 mg/L of indocyanine green (a fluoroescent marker) to allow precise measurement of sample dilution using a fluorometer.

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

Statistical methods / analysis

We intend to recruit up to 35 healthy participants to take part in this study. These participants will be divided into two groups with up to 25 participants in the first group and up to 10 in the second.
We would like to ensure a minimum final sample size of 30, and do not expect drop outs to be a significant issue as the study involves only a single visit. A sample size of 30 and our predicted measurement variability (standard deviations of ± 1 µL in blood volume and ±5% in blood dilution) will allow us to observe differences between the groups as low as 0.84 µL in volume and 6% in blood dilution (a=0.05, ß=0.1).With a minimum sample size of 20 in the first group we predict we will be able to distinguish statistically significant differences between groups whose mean dilution differs by as little as 10% (s_glucometer=0.6 mmol/L, a=0.05, ß=0.1). We predict we will be able to observe differences in mean dilution as low as 5% in group 2 with a sample size of at least 8 (s_fluorimeter=3% , a=0.05, ß=0.1). Sample volume is measured identically across both groups and we predict we will be able to observe differences in mean volume released as low as 0.84 µL (s_BloodVolume=1 µL , a=0.05, ß=0.1).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/11/2019

Actual

1/09/2020

Date of last participant enrolment

Anticipated

1/04/2020

Actual

4/12/2020

Date of last data collection

Anticipated

2/04/2020

Actual

4/12/2020

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

Associate 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]

University

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]

Health and Disability Ethics Committees, New Zealand Ministry of Health

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]

20/09/2019

Approval date [1]

21/08/2020

Ethics approval number [1]

19/NTB/168/AM01

Summary

Brief summary

Currently, diabetics work out what volume of insulin to inject based on a blood glucose measurement made by pricking the fingertip with a small needle (lancet). This uncomfortable process must be performed multiple times per day in order to measure and maintain the balance of glucose and insulin in the body. To avoid the use of lancets and needles, we have been developing ‘jet injectors’ that use only a thin stream of liquid to penetrate the skin. We believe a jet injector can avoid the issues associated with lancets/needles while also producing an equally useful measurement of blood glucose. This is the idea that we plan to test in this study. Specifically, we will test the ability of the liquid jet to prick the skin in a similar way to a lancet and what effect, if any, this has on the measurement of glucose concentration. We are also interested in investigating whether the jet injector is able to achieve this with less pain and discomfort relative to a lancet.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/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
4844	Study protocol					378392-(Uploaded-08-09-2020-08-52-26)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Jet-Induced Blood Release From Human Fingertips: A Single-Blind, Randomized, Crossover Trial.	2023	https://dx.doi.org/10.1177/19322968211053895

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically