None listed
Conditions
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.
Interventions
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 u
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.
Sponsors
Associate Professor Andrew Taberner
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
20 Years to 59 Years
Healthy volunteers
Yes
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)
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
Outcome results
None listed