Trial Review

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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 information initially 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] 299311 0
None
Universal Trial Number (UTN)
U1111-1240-5083
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 314443 0
Condition category
Condition code
Metabolic and Endocrine 312781 312781 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 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] 315578 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 thier own control.
Control group
Active

Outcomes
Primary outcome [1] 321407 0
Blood volume. Measured by the height of fluid collected into a cappilary tube of known dimensions.
Timepoint [1] 321407 0
A single measurement will be made on each of the blood samples within 2 hrs following the interventions.
Primary outcome [2] 321408 0
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] 321408 0
A single measurement will be made on each of the blood samples within 2 hrs following the interventions.
Secondary outcome [1] 374887 0
Percieved pain, using visual analog scale.
Timepoint [1] 374887 0
Measured immediately after each intervention.
Secondary outcome [2] 374888 0
Blood glucose concentration. Measured using point of care glucometer (CareSens N).
Timepoint [2] 374888 0
A single measurement will be made on each of the blood samples within 2 hrs following the interventions.
Secondary outcome [3] 374889 0
Percieved ongoing pain.
Measured using study specific questionaire.
Timepoint [3] 374889 0
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
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 21865 0
New Zealand
State/province [1] 21865 0
Auckland

Funding & Sponsors
Funding source category [1] 303831 0
Government body
Name [1] 303831 0
New Zealand Ministry of Business, Innovation and Employment
Country [1] 303831 0
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] 303958 0
University
Name [1] 303958 0
University of Auckland
Address [1] 303958 0
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 303958 0
New Zealand
Secondary sponsor category [2] 304060 0
University
Name [2] 304060 0
James Mckeage
Address [2] 304060 0
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
Country [2] 304060 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304346 0
Health and Disability Ethics Committees, New Zealand Ministry of Health
Ethics committee address [1] 304346 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304346 0
New Zealand
Date submitted for ethics approval [1] 304346 0
20/09/2019
Approval date [1] 304346 0
21/08/2020
Ethics approval number [1] 304346 0
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 96626 0
A/Prof Andrew Taberner
Address 96626 0
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand
Country 96626 0
New Zealand
Phone 96626 0
+64 9 923 5024
Fax 96626 0
Email 96626 0
[email protected]
Contact person for public queries
Name 96627 0
A/Prof Andrew Taberner
Address 96627 0
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand
Country 96627 0
New Zealand
Phone 96627 0
+64 9 923 5024
Fax 96627 0
Email 96627 0
[email protected]
Contact person for scientific queries
Name 96628 0
A/Prof Andrew Taberner
Address 96628 0
Level 6,
Auckland Bioengineering House, University of Auckland
70 Symonds Street,
Auckland, 1010
New Zealand
Country 96628 0
New Zealand
Phone 96628 0
+64 9 923 5024
Fax 96628 0
Email 96628 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
4844Study protocol    378392-(Uploaded-08-09-2020-08-52-26)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Xu, Jiali, James W. McKeage, Bryan P. Ruddy, Poul ... [More Details] 378392-(Uploaded-11-11-2021-05-55-10)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseJet-Induced Blood Release From Human Fingertips: A Single-Blind, Randomized, Crossover Trial.2023https://dx.doi.org/10.1177/19322968211053895
N.B. These documents automatically identified may not have been verified by the study sponsor.