eedle-free Blood Glucose Sensing

Not Applicable

Completed

• Conditions: Metabolic and Endocrine - Diabetes; Diabetes

• Registration Number: ACTRN12621001572853
• Lead Sponsor: Professor Andrew Taberner

Brief Summary

We have found that the application of suction significantly increases the volume of capillary blood collected following either lancing or jet-injection. The samples collected after jet-injection show statistically significant increase in dilution than samples collected after lancing. There was no evidence of any difference in pain between the interventions. Blood glucose concentrations were statistically equivalent within the accepted glucose test strip accuracy. For all interventions, there was no ongoing pain in the following 24 hours.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-18
• Study Completion: 2022-09-23
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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)
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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Volume. Measured by area of blood in a picture taken of blood within a capillary with known internal dimensions[A single measurement will be made on each of the blood samples within 2 hrs following the interventions.];Dilution of blood sample.<br>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.<br>[A single measurement will be made on each of the blood samples within 2 hrs following the interventions.]

Secondary Outcome Measures

Name	Time	Method
Perceived pain, using visual analog scale.[Measured immediately after each intervention.];Blood glucose concentration. Measured using point of care glucometer (CareSens N).[A single measurement will be made on each of the blood samples within 2 hrs following the interventions.];Perceived ongoing pain.<br>Measured using study specific questionnaire.<br>[Questionnaire will be completed 24hrs after the interventions]